IQVIA Holdings Inc. (IQV) Earnings Call Transcript & Summary

All right. Good morning, everyone, and welcome to our symposium today here at -- in Chicago, and welcome to those who are joining us by live stream or on-demand viewing. We're delighted to host this session today and looking forward to a very productive 90 minutes. So I'm Murray Aitken, I'm Executive Director of the IQVIA Institute for Human Data Science. It's my pleasure to moderate this symposium, which has been planned and organized by the Institute in collaboration with our colleagues in the IQVIA Oncology Center of Excellence, which includes Rachael Fones, who joins us on the stage today and we'll be hearing from later. But the idea is to really have a multi-stakeholder, direct and dynamic discussion on the topic of designing and delivering diversity in oncology clinical trials. And I know that this topic has risen to the top of the agenda by -- for many stakeholders in recent times. We also know this is not the first discussion of this type, but we are hoping that today we can move the ball forward, be pragmatic and realistic in terms of how we can advance towards the goal of increasing diversity and representative diversity in clinical trials. And to help with that, we have a truly exceptional panel of speakers. We're very appreciative of everyone's willingness to join us today and contribute to the discussion. And I thought we'd maybe just start off by going down the line and having each of the panelists introduce themselves, their affiliation and what brings them to this topic. So we'll start with Bardia, and then we'll just go down the line. Bardia, welcome.

Thank you. I'm Bardia. I head the Oncology Clinical Operations Group at AbbVie. Quite excited to be here. Obviously, it's a topic that has been on top of [ many's ] agenda, but just in the aspect of the health equity and access to healthcare for everyone, I think it's a public health issue. So glad to be here and talk about it.

Great. Thanks.

I am Tania Small. I'm the Global Medical Oncology Head at GSK. I also chair the diversity, equity inclusion R&D program at GSK. And why am I here? I mean, I think we've been talking about clinical trial diversity for now decades, but I think this is the first time in a long time we've seen some action associated with it. so I am excited to be here and talk about [ resolution ].

I am Rachael Fones, Director of Government and Public Affairs at IQVIA and a strategic adviser to our diversity in clinical trials, offering an internal -- both internal and external with customers and also continuing on the public affairs front by engaging with regulators and policymakers. What brings me here today is the same thing that brought me to this issue, well, decades ago, but within -- we've been into it as a [ CRO ], I saw it as a policy opportunity. Everybody was talking about in Washington. And I thought, well, surely, we can engage and make a difference. And what struck me is the same thing that struck me then is there must be some friction in the difference between what we want to achieve and what we can achieve. It's a complicated business. It's a complicated thing. And so trying to build that understanding and find where those opportunities are for pragmatic steps forward in achieving it is a passion of mine. And the fact that we're here today and the discussion has changed so much, it's fantastic. But there's no place more clear than oncology, where the need is there, and we need to make it happen, but it's so challenging to what's there. So I'm excited about this conversation to get at those challenges.

Well, good morning. Amanda Bilbrey. I'm the AVP, Research Operations at Sarah Cannon Research Institute. So our organization has recently expanded. We've entered a joint venture, so we now have over 250 locations in the community setting and the 1,300 physicians, and we treat about 1 in 5 patients in the community. So that is -- that, in turn, is the reason that I'm excited to be here. We share -- I mean, I think in order to be able to impact the most amount of patients not only be in the community setting, but offer a diverse group of patients the opportunity to enroll in clinical trials. So glad to be here.

Good morning, everyone. I'm Lola Fashoyin-Aje, I'm a medical oncologist. I wear 2 hats at the FDA. I provide oversight over multidisciplinary teams reviewing oncology development programs for solid tumor malignancies. And I'm also an Associate Director in the Oncology Center of Excellence, where I lead some regulatory science policy initiatives, one of which is project equity, which I lead and whose aim is to improve the representativeness and diversity of the study populations in clinical trials. I'm here because I am singularly driven and motivated by the real need to act on our collective commitments to improving the diversity of our clinical research participants. This has been a passion of mine since well before I became a medical oncologist. And I will participate in any and every conversation that leads to actionable implementation of the various policies. Thank you for inviting.

My name is Manuel Espinoza. I'm an Assistant Professor of Medicine at the University of Alabama at Birmingham, where I practice as a malignant hematology [indiscernible] specialist. And the reason why I'm here is because -- basically because of my daily practice of medicine, my patients come from all walks of life and have all different kind of ancestries. And I want them to be able to access the latest and greatest medications and trials because at the end of the day, what we want to do is make them live longer, hopefully cure their cancer, help them have a better quality of life. So I think everybody should be able to access that. Thank you for having me.

Hi, everyone. I'm Jen Horonjeff. I'm the Founder and CEO of Savvy Cooperative. If you're not familiar with Savvy, we are a patient-led organization that focuses on patient insights and user experience research. I myself been a patient, and a researcher. And what we do is help to elevate those voices of the everyday patient as well. And so I'm here to make sure that we're also thinking about those stores, the real tangible experiences that we hear in our work day to day to make sure we don't lose sight of it by just kind of talking up here, but understand the actual impact on what patients are saying.

Good morning, everyone. I'm Yasmeen Long. I am recovering from my allergies, but I'm [indiscernible]. I'm a Director at FasterCures, which is the center of the Milken Institute. The Milken Institute is a nonprofit, nonpartisan think tank. I'm based in Washington, D.C., but we have offices in Los Angeles, Santa Monica, Abu Dhabi, London, Singapore, New York and Miami. I lead our health equity portfolio, where we are looking at achieving health equity across the entire biomedical research ecosystem, and that includes how we focus on diversity in clinical trials, the role of diversity in the medical and health research workforce, also the role of patient and community engagement and the role that, that plays in increasing diversity and equity across the system. And then also looking at the role of digital technologies such as decentralized clinical trials, wearable devices, how data is collected and how we apply that and to really make action -- taking action into this issue because as we've said earlier, it's just something that's been taking place for decades. So why are we still here -- why are we still here?

Why are we just beginning?

And why are we just beginning? Exactly. So I'm here to be very frank and of course, join my fellow panelists on this important discussion.

I guess one last. My name is Pat Russo, I'm a medical oncologist. I practice at Yale University at Yale Cancer Center and one of the [ professors ] of medicine there. And I run the Early Phase Clinical Trials program and, I am the Associate Center Director at the Cancer Center for Investigator -- Experimental Therapeutics. I've been doing early-phase clinical trials all my life, formerly in Detroit, Michigan, currently for the last, soon to be 9 years at Yale University. First and foremost, I believe it really expands way beyond inequalities in clinical trials. I think the problem is lack of health equity across the board, especially in the United States. I think clinical trials and the inequalities that we see in terms of lack of recruitment of underrepresented populations is just part of the big picture. And so focusing on recruitment of underrepresented populations in early clinical trials, I, over the last few years, have been working towards hybrid decentralization project, where I only do early-phase trials. They're very difficult to place in community settings. But what we're doing is bringing those trials into community settings that are high underrepresented populations in hopes that we can service their social and structural determinants of help. And by doing so, we can increase their accessibility to what I think are some of the best therapeutic interventions for patients with advanced metastatic solid tumors.

Great. Thank you, and I really do look forward to hearing everyone's contributions this morning and bringing the different perspectives that you're coming from at this issue. In terms of how we're going to spend our time, I'm first going to share some research findings from work that we've done at the IQVIA Institute, and then we'll divide the discussion into -- really into 3 parts. First, we want to talk about the sort of unique oncology recruitment and diversity challenges. How the number of -- and type of trials has evolved? What impact that has on the ability to bring representative populations into trials? So that will be the first segment. Then we'll move to the second, where we want to focus on how to enable diverse patient populations to enter trials and especially the value propositions that are effective in bringing those populations into the trial system. So here, we want to -- we do want to focus on what works, what's working, what makes a difference, where we're seeing some of the traditional barriers that we've been talking about for a long time, actually overcome. So we want to make this positive forward-looking and demonstrate that we know where progress is being made and can be made. And then the third section really comes back to this issue of finding the right balance between achieving representative diversity in trials, while also moving novel treatments through the confirmatory trial phase and regulatory review and ultimately to the patients who will benefit from them and doing that as quickly as possible. So we'll look at the levers that can be adjusted and how stakeholders can best partner with the regulator, with FDA to agree on the right goals and actions that go into the oncology diversity action plans, which are now -- will be required to be submitted. So that's how we want to sort of divide up the time we have. And let me just quickly run through -- sorry, Pat, you may want to adjust your chair, and Yasmeen, a little bit as well. Just to run through some of the research that we have published that's in the public domain, it includes this new report, Global Oncology Trends, 2023 that we just released. And I think we have some hard copies for you on the way out if you prefer printed material. But we've also done a report late last year on advancing diversity in clinical development. And we also do an annual trend report on what's going on broadly in R&D that, if you haven't seen this, you might find them of interest. So I don't need to dwell on this slide, but it is one that we should always remember and I think position what we're talking about here in terms of the issues of representative diversity and trials in the broader context, as Pat mentioned, of disparities in health outcomes. So from the work that we have done and the position that we take, what matters is that right-hand side where we see the different mortality rates by demographic index to the total population and where you can see across all cancers, there's a 12% higher mortality rate for Black and African Americans. But then when it comes to prostate cancer, it's 93% higher, it's 83% higher for multiple myeloma and so on down the track. We also recognize that socioeconomic barriers are real and are part of the issue. And I think this is where we also need to recognize that we can't solve all the problems at once, but that doesn't -- that shouldn't prevent us from solving the problems that we can solve and making progress where we can. But keeping our eye on this as the prize, we think, is important. Another sort of principle that we have taken with our research is that when we talk about diversity in clinical development programs, we need to ensure we're not only focusing on enrollment in confirmatory trials. That gets a lot of attention. The FDA snapshot reports draws a lot of attention to pivotal trials for approved drugs. But we recognize that there are important elements here, both in terms of target discovery and exploratory trials as well as, importantly, I think, in post-approval real-world use of the medicines. Once they've been approved, are those medicines reaching the populations who will benefit from them? And are we seeing the outcomes, both from an efficacy and a safety perspective, for those subpopulations and especially underrepresented populations? And so we do think also that this is a picture worth keeping in mind, even as we maybe narrow down our discussion to talking about underrepresented populations in Phase I trials or in Phase II, Phase III trials. A couple of other pieces of the story that are important to remember is, there's a lot going on in oncology, and I don't need to tell that to anyone in this room, I suspect. But the pipeline of oncology molecules is at an all-time high. It's increasingly diverse in terms of the types of mechanisms that these new molecules in development are bringing forward, including what we refer to as next-generation biotherapeutics at the top of the bar there, both for hematological cancers and solid tumors. There's a lot going on. By our count, about almost 700 molecules in development for Hem-Onc and about 1,900 for solid tumors across all of the modalities. We also know that new oncology clinical trial starts are at all-time high levels. This is why everyone feels stretched. If you're a sponsor trying to make decisions about priority candidates to advance, if you're a site, if you're an investigator, if you're a CRO, right, everyone is working at capacity. And we've been climbing that rather steep uptick for some time. The pandemic has had an impact. You can see the flattening there. But we're still up 20% over the 2018 levels, with about 2,300 new oncology trials slated to start in 2022. And you can also see the split on the right between rare and nonrare solid and [ hem ]. So there's a lot going on. And I think that is part of the background and the context that we're dealing with. This is also a part of the story, and this is based on our analysis of the completed trials that have reported their results and demographics on to clinicaltrials.gov, and showing the -- so where oncology sits relative to other therapeutic areas. So it's at the right hand there but also, on the right-hand side of this chart, showing the progress over the past decade. And you can see the trend line there. Certainly, for Black and African Americans, participation in trials has fallen from about 9% back in 2013 to 4.2% in 2022. Hispanics, a little higher and a little bit of a mixed trend there, but still ended up with the, again, completed reported trials in 2022, representation of 7.6%. The dotted lines indicate cancer incidents for those 2 groups. And again, we know there's lots of reasons behind this. This is not the sort of only metric that we should be using. But it is one that we can access, and we can see and we can reflect on what it tells us about the progress that is being made. This is a little bit of a deeper dive, where we've taken 8 specific cancer types and indexed them relative to mortality rates by -- for White Americans, Hispanics and Black, African Americans on the X-axis and then the inclusion in the clinical trials on the Y-axis. So on the left part of the chart, you can see the green dots there, that's White population for those 8 cancers all crowded around the 100 lines. And then you can see on the right-hand side, we've sort of taken apart the African-American and Hispanic dots, rescaled it, and you can see the level -- this is a decade-long cohort of studies, Phase I, II and III that we looked at. So for all cancers, for Hispanics, the mortality rate is 72 against a U.S. mortality rate of 100, the inclusion rate relative to the epidemiology is at 53. And then for Blacks, it's 112, I mentioned before, on the [ mortality ] rate and a 45 score against the index on a 100, based on the epidemiology of those cancers in Black, African-Americans. You can also see there's a fairly wide spread there, and that may be something we come back to in the discussion. We've also taken a look at some of the potential dimensions that contribute to greater or lesser levels of inclusivity in trials. The first panel are the -- measures a number of inclusion/exclusion criteria. And then the bars are based on quintiles of all the, again, completed trials during the 10-year period, 2013 to 2022, and shows the clear correlation that has been talked about before, more inclusion/exclusion criteria correlates with lower inclusion rates in the trials. And again, these inclusion rates are all indexed against the oncology incidents set at 100 for that -- for the 2 racial ethnic groups. The next panel is showing the number of subjects in the trial, and again, some correlation there. And then the third panel looking at the number of sites also by quintile and showing that correlation as well. The number of sites will -- to the extent there's 1 site that is going to be a U.S. site because these are all trials that include at least 1 U.S. site, even though the analysis is based on the totality of the global trials. So again, not too surprising that when there's 1 site in the U.S., the inclusion level is higher. And as you include more sites, that often means more ex-U.S. sites, then the inclusion rate is going to decline. But one additional analysis we've done is actually then to isolate trials that only have U.S. sites, so U.S.-only site trials, which historically have been about 40% of trials. Again, this is all Phase I, II, III interventional trials with industry sponsorship. It has fallen, interestingly, in the last couple of years, and we're not quite sure what's been driving that. But a significant number of our clinical trials do have sites only in the U.S. And there, you can see on the right-hand side, again, not surprisingly, we can see higher rates of inclusivity, again, indexed against cancer incidents. Though, again, the trend line over time has been falling and falls well short of 100 in these views, better for Hispanic than for Black African-Americans. A couple of other things to throw in the mix. Not all oncology trials are the same. And we do think that talking about sort of archetypes of trials may be helpful and differentiating those that are for rare cancers, where there's very sort of niche populations for one reason or another. And on the other axis here, the sort of extent of the unmet need or the -- or where naive patients may be hard to find. So these are other considerations we think that are relevant in the context of why are we still discussing this and how do we make progress. And on the right-hand side, again, we've sort of illustrated where different tumor types may fit within that sort of archetype framework. Finally, when we think about the key questions and the levers to consider in building an optimized oncology diversity plan, we sort of think about these sort of interconnected 4 different levers you can see going around in the circle. One is the inclusion and exclusion criteria that are incorporated into the trial protocol. We know that, that is a variable. And as you saw from the data, it demonstrates the extent to which that is a factor. Country mix is clearly important as well. And U.S.-only trials do look different than global trials. But they also look different in more respects than just the inclusiveness level, and we can get to some of that. The site mix, partly the mix of community sites, academic medical center sites, on top of the country mix, is another variable to think about. And then the approach to patient screening and the effort and the value proposition that gets presented to patients, we think, is sort of the fourth lever here, right? These things all go together in order to answer the questions around the outside. And just, finally, from a sort of illustrative perspective, this is the way we think about the -- striking this balance between optimal speed to advance therapies through the pipeline and to the patients who will benefit from them and the inclusion of representative populations in those patients. And there's a series of trade-offs we sort of illustrate with the curves there between the level of diversity and, if you like, the investments that goes into the trials, and that could be a mix of money and time and risk that are all considerations when designing protocols and when executing the trials. So that's sort of our view of what we're facing. So a little bit about the sort of context of what's going on broadly in clinical trials and the sort of all-time high level of activity, some of the sort of recent data in terms of what we are seeing in terms of the representativeness of ethnic and racial groups within those trials and then some of the considerations that I think we'll get to discuss. So that's enough for me. There's more of all of that in our reports, you're welcome to chew over. But for now, let me come back to the panel and bring us to the discussion.

So again, we've got 3 segments to walk through. And I want to start with really just a reflection on the challenges. We don't want to overplay this because we know there's a lot of them. But I think getting a sense -- and maybe starting with Bardia and Tania from a sponsor perspective, in terms of what they're experiencing, what they're seeing. In the context of your trial portfolios and in the context of your efforts to improve the diversity that you include in your trials, what's going on, what do you see happening? What do you see as the challenges that you're facing? And I'll just -- since Bardia's next to me, I'll ask you to lead off.

Absolutely. I think not only within oncology, but in general in drug development, there has been more emphasis on really better planning for inclusion of diversity proactively. I think if you want to reflect back about a year ago or even 2 years ago, we tried to retrofit our protocols and try to add different components to make it -- to meet the diversity and inclusion requirements. But now, we are actually taking a much more proactive role. Needless to say, there has been more emphasis on this issue, both in the communities, but also from regulators as far as what the request is, what the expectations are. And that has impacted how we think about the conduct of the clinical trials, about the placement of the clinical trials and the design of the clinical trial. So in all, it's a much more comprehensive look and a clinical development plan in general to be able to meet this [ claim ]. One other thing that actually is coming to forefront in this discussion is that if you look over time, the percentage of the patients coming from the U.S. in all trials, including oncology, has been declining, it's been declining in the past 20, 25 years and is continuing that trend. Now we may see more centers, but the patient numbers are decreasing. So we have a compound problem. What the population we have in the trial is going down in the U.S. while we want to increase the diversity of the patient population. So it goes a little beyond the equity and inclusion of the patient population, but also how do we increase the proportion of the patients within the U.S., either a representative patient population. And then the second part of that, how would we include diverse patient population upfront?

And I completely agree, and we've been looking at this over time. I mean I'm thinking about back in the days when I was in med school, and I saw something like risk factor for death. And it was like Black race, Black race, Black race. No matter what disease it was, it was Black race. And when you would ask those questions, we go back into talking about [ dispute ] and the mistrust and then over to 2,000, mistrust. And then we become -- we stated just blame the victim, the victim, these people did not trust the physicians, and therefore, they weren't getting the right healthcare and they didn't come on clinical trials, full stop. And that was a discussion. And so I would, say over the last few years, and really COVID seem to me push this at the forefront even more, we've taken a real look at the challenges, the real institutional barriers that are preventing people of color from coming on clinical trials. And I think this is where I see a big pivot because we are now heavily investing in making sure that we're increasing the true representative -- representation of patients on clinical trials. So with that, I would say that, we now have most pharma companies in GSK, beyond GSK, we have teams solely focused on how do we improve access of clinical trials, how do we improve the representation in clinical trials and how do we improve the retention of people of color on clinical trials. And we've taken a hard look. We've looked at from our protocols as you talk about the inclusion criteria. [indiscernible] we reset baselines because our baselines are based on usually just white males. And you realize a lot of people were excluded because of that. So we're looking at that, looking at consent forms, why are they only in one lane, which how do we make sure that they're accessible, and let's understand the culture that the people who are reading it, how do we meet their needs. And then we look at institutions. And quite frankly, a lot of physicians were not even offering patients of color clinical trials. And we know the data shows that, yes, when you ask them, would you come on clinical trials? The answer is yes, when you offer, the answer was no. So a lot of us in the industry are now going to these sites and saying, if you want to participate on our clinical trial, you need to be upskilled on and culture competency and cultural intelligence, understanding your patient population. And then another look at the true barriers, they can't even get to our sites, the cost, the extra lab tests, that extra -- just the burden that we demand of patients. And so we've done a lot of work, investment, that's how do you decentralize trials, but also how do we make sure that the trials are now in the communities where these patients are. So I can tell you like GSK alone, we have switched the mix, where 75% of our trials now are actually in the community and 25% of them are in academic center because that's where the patients are. And we've lasted out to many sites. Instead of doing a finite group, we open it up, and we're investing in it. And then we hold the sites accountable, how do we even work with you to make sure you are recruiting? So I think there's a lot more thought that we're putting in to ensure that we do all that we can to recruit diverse patients down to clinical trial material. But I think that has been a big shift because when we stopped and just said, "it's a mistrust issue", we sat on it and just let it happen. But now because we're identifying the real institutional barriers, we're starting to see a big change. And some of our numbers are really reflective of it. But I think that's been the change, that's been, to me, the promise to hope that I'm seeing. And again, we're putting our money where mouth is. And again, not just GSK, but across the industry, I'm seeing a big collaboration across pharmas saying how do we work together not competitively, but together to improve this.

Amanda, do you want to -- just speaking of sites, 75% focus on community sites. Again, from the -- I mean just we do want to focus a bit on the challenge that's out there, and then we'll talk more about the way forward. But how do you see the challenge today?

Yes. Time to hit on a lot of the pieces that we really encounter. A lot of it is around access to the site in general, like patients -- we're in the community. And a lot of the communities, patients don't have ready access to things like transportation or housing -- or lodging, excuse me, and things of that nature. And so how do we provide them access to that on the front end? So many sponsors and CROs offer reimbursement, but the challenge is patients don't have that front-end ability to front those costs. So I think that's a big piece. You also talked about the informed consent forms. When we are in communities with patients that speak other languages, and they have to have their consent forms in their native language, that process is very lengthy and laborious. And we're dealing with cancer patients, they don't have that kind of time. And so expediting that process and working together to figure out what those -- how we can do that more efficiently, I think, is a big part of it. Education in the community, so you talked about the -- there is still -- it always -- I'd say, surprises me. I just find it unfortunate that even today, there's still a lot of mistrust, a lot of misunderstanding about what going on in clinical trial is. And so how do we help better educate about what it truly is as opposed to what the perception is? And I think that will help us in ensuring that we're diversifying our enrollments at our site in helping our community.

And maybe move to Manuel. From your perspective, there is an [ investigative study ] maybe with a -- on Hispanic populations. How do you see the challenges today?

Yes. Thank you. I think some of the challenges that we faced, I think Tania made a lot of good points on how to best tackle -- another one that I wanted to mention is sort of pivoting the last comment that geography is not destiny, but it's a big part of this. So if you're trying to target a specific population, whether these are Hispanics or Asian-Americans or African-Americans, you have to be cognizant of "I want to open or give more slots to this center." And it's not something nice to see, but I think it just reflects reality. And in that way, being deliberate and being conscious of where this population is located at, whether it's [ SEER ] -- looking at [ SEER ] data or a state cancer registries and looking at the ethnic breakdown of patients with a specific malignancy, that would tell you this place -- specific place will give you more [ bang for the buck ]. And then not to our own [ horn ], but [ DAV ], for example, at least in the [ malignancy ] hematology space, we recruit a lot of patients from my [ myeloma ] trials. Same thing with [indiscernible]. And it's just -- it's not -- we're not magicians, right? It's just we have the population, and we include a [indiscernible] getting into our trials. And I think that sort of effort can be replicated in a lot of cities. In -- the Southwest has a large Hispanic population from the malignant hematology standpoint. ALL is a bit -- I think [indiscernible] that all-time [indiscernible]. They should be focusing there. And I don't think at times -- or I think that's something that needs to be made more deliberate and more upfront.

And if I can add one up on that because I think one of the challenges to your point in terms of geography or even site selection, we tend to go to the same sites over and over and over again. We know the investigator as well. We know that they're going to recruit. We want to move fast. And so what you're doing is -- I mean you're isolating a whole sector of the investigators who have actually worked where the patients are. And that's something that I think we've really, just in general, try to change, but I think that's been, and still is, a huge challenge. How do you expand out beyond your typical site because you're facing it as a timeline that you need to deliver quickly, so that's your default. But I think that's one of the things that we're tackling because now we're seeing when you do go into those sites, we do provide the right resources, then you actually get the patient population that have the disease.

Right. One...

You have to make sure that when you're going into those new communities, you train physicians because there's nothing worse than recruiting patients for which data cannot be effectively utilized. That's almost worse than not collecting the data.

Yes. And here's the thing -- I mean this is one of the -- and I don't -- I guess we're going to talk about physicians later, but that actually is one of the things I think we, as an industry, need to just start talking about and actually investing in, really upskilling, to your point, the physicians in the community. We pumped a lot of money into the academic institutions to help build some of that infrastructure so they can do the clinical research. We need to use the same type of resources to do the same thing in the community because that's the only way, to your point, it will be successful.

And one of the strategies we put in place actually is almost like an academy for investigators that are not as experienced in clinical research to teach how the clinical research is done, what are the infrastructures you need, what is the process. So we always say that by the time you have a trial, if you want to do that, it's too late. So you already put this investment ahead to create that awareness, [ grab ] that community, so when time comes and the need comes, then you have a pool of investigators ready to participate.

And then, may I? I don't know that talking about challenges is not my favorite topic, absent solutions to go along with them. But just to add on the -- some of the statements that a lot of my fellow panelists have mentioned here, I think there was -- mistrust is something that comes up a lot. And I think that in some regard, it's sort of self-inflicted, right? We have -- and to me, I don't view the trusting abilities of these communities to be amiss really, considering sort of how we have engaged with them in the past, and how we've come short, really falling short of really our commitments to those communities. So to me, that's sort of our problem. It's not a problem of the communities or the patients who are members of these communities. So that's one thing. And I also -- the other point is that trust is a bidirectional thing. And so I think many of us need to really ask ourselves a question, do we trust these communities? Do we trust participants who are members of these communities to know what's a priority and to know how the disease affects them and to understand what their sort of ability and willingness to participate in that -- in the clinical research. So it's not a one-way thing, where the patient should trust us. And we're working hard to ensure they trust us. I think we also have to work on how [ we ] are partners in that trusting relationship and ensuring that the relationship is one that is being built and that it's sustainable and that is mutually beneficial. Because if you're a member of a community that's been historically not included in clinical research, all you see is these profits, right? You see all these drugs coming on the market. You see all this money that a lot of different stakeholders are making, and you hear them talking about representativeness and how everyone is committed, and you don't see anything that's different. So our -- these communities are very smart, and they know what's up. And I think that it's really -- I'm very pleased to see very tangible actions being implemented. But I think we have to kind of redefine how we even speak about the challenges because they're not always out there, sometimes they are within, and it's a huge cultural shift, I think, that needs to be undertaken. And I think one that we don't talk a lot about, we talk about sort of our outward efforts to address challenges that are out there, but it's really important to also be very transparent about barriers and challenges within, right, that may impact how we deliver on our commitments.

Was that you, Jen?

Yes.

Go ahead.

Let me build on that because it relates directly to what everybody here is saying and about trust and so to bubble up some actual patient stories and the conversations that we're hearing. Back when the COVID-19 trials were happening, one of the patients that I had spoken with, who was in a tribe -- indigenous tribe up in the Pacific Northwest, had said that their tribe was approached to participate in the vaccine trials and that new tribal elders had asked about various questions. Of course, this is a community who has experienced a lot of historical injustices. They were doing their due diligence and just asking smart questions. And they didn't get the answers that they were really hoping to get answered, so they declined to participate. However, this patient was making sure that we understood that when the vaccine was actually approved and came to market that their tribe was vaccinated more quickly than the general population. Because when they have the data, they had the information they were looking for, then they felt comfortable. So this goes back to the informed consent process, how are we communicating that information to people that wanted to participate, but they were like, "This is shady. If you're not going to tell me this information, no, thank you. We've done this before." So I think that, that's important to bubble up. And also, I like this framing about turning within, and how can we make sure that this trust is going both ways? I never forget a conversation that I had with one patient when speaking about decentralized trials. And I think, in the pandemic, we're all in our ivory tower being like, "Oh, here are the solutions. Let's just throw all this technology at patients. We're going to go to their homes, everyone's going to love it." And one patient I remember talking to them, and they were African-American, and they were saying, "I don't want to see the look on the person's face as they're walking into my housing complex looking over their shoulder not feeling safe." So thinking about that, that like even like the training of the team and how that can really play into somebody feeling like "If you don't feel like you can be here, then I don't want to hear." So really making sure we're thinking about that.

Yes. And another piggyback on this trust factor, thinking of two things. One, you have to engage with the community, right? And I think sometimes -- that doesn't mean you're just knocking on individual people's doors, but building relationships with the people that are -- you want to interact or study. And not just coming in and say, "Hey, well, we thank for the data, see you." But also, what impact does the research have on them? Is that being communicated to them? And also valuing lived experience as expertise, right? I mean, they know their [ price ]. They know what they're dealing with. They might not be speaking the [ king's english ] or whatever. But the truth is the lived experience is expertise, and I think it should be valued. One other thing I want to mention quickly about the mistrust we talk about, disparities and mistrust in the health care system, we say Tuskegee. And most of us in this room are probably familiar with what Tuskegee is, but a lot of people aren't. It is the United States public health study on syphilis at Tuskegee University. In other words, the United States government put that study on for 20 years, okay? Where there was a syphilis treatment available, and it wasn't given to this particular black males. They've given them...

They were given the syphilis.

Yes, they were given the syphilis. Exactly.

They were infusing syphilis into the black population.

Exactly. Right. And that runs pretty deep in terms of...

There are other examples like that...

Many, several horrors, I'd like to call because that's where they are in terms of all types of underrepresented populations. And on another coin, it could be -- you walk into your doctor's office. And no one says good morning to you, doesn't speak to you, doesn't look you in the eye, denies your pain. So I think all of these are the types of things that have to be considered when we're thinking about trust and how we're showing up into communities or how clinical trial researchers are showing up into communities and not just coming to get the data, but actually treating people as human beings and recognizing them as such and making sure that there's a bifold impact and investment in that community as well as providing that investment and getting that accurate data collection.

And let me make sure not to forget, Rachael and maybe to bring the perspective from, as a CRO, right, that, to some extent, gets caught in the middle, perhaps, between sponsors and sites. I mean your sort of reflection on the where we are in terms of the challenges that are faced as a CRO.

Right. Well, first of all, I think we -- the conversation that we're having here is amazing because you talked about people, thinking that the solution is that the community needs to trust us. That has been the issue as we throw money out at, I think. And that's the issue. And the issue is more so upfront. And the diversity planning guidance did what we had been advocating you needed to do, which is decide what your goal is. What does that population look like, embedded into your thinking? Will my protocol actually accomplish this? Will my site selection strategy have a chance of accomplishing this? Because for the most part trials, and I think, Bardia, you mentioned it, we were retrofitting it in the past. When you do that, of course, your trial will not be diverse and on time. Of course, you will fail, right? And so the [ scene ] change that you've seen is not just people being interested in it, but actually planning ahead. And huge credit to you all because you guys have been in this. I think we need to recognize that having enrollment goals, adding a criteria to a clinical trial causes consternation among clinical operations people. It just does. It's not because they don't care. And they have many other things they need to do. So the challenge is, as you try to get people to see this the right way and try to even pass those goals on down to the sites, how do you help people get comfortable with it that it's not so much at pass/fail, but at do better? This is where we need to be. And then you implement all these strategies that we're talking about. But until -- and in helping those who are in charge of doing these things get comfortable with that, I think it is important. But I think you should feel really good -- see the impact because that's what you see up here today so...

Can I just throw out 1 other variable that I don't hear talked about as part of the challenge? And that is insurance coverage, Medicaid.

Oh my God, yes. So should we deal with that as investigators? It is real.

To what extent is this part this need -- to what extent does this need to be part of the solution? Should we frame it that way?

Yes. So 1 of the problems is not necessarily that they won't let patients go on trials, but right now, I think the important thing is, how are we going to pay for all those data points that would not be standard of care? And so we've made a shift recently from doing Medicare coverage analysis in-house to farming it out to a CRO to do it for us. And it's made a huge impact already in a very short period of time. Because our internal process would look at all of those different tests. They'd go through the calendar and all of those different things, standard of care versus research, standard of care versus research. And when you're on an early phase trial, and you're being assessed every 8 to 12 weeks, you have to have a chest abdomen and pelvic CT scan, but lung cancer patients don't need pelvic CT scans. It's another $2,500 to $3,000 per scan depending on where you are. And so third party -- so what we've done is with the CRO, we've shifted from putting a lot of the standard of care things that now on the onus of the pharmaceutical company. And I know it's more money for them. However, I think that it will make an impact because of the fact that we will assure that those data points are obtained, and we won't have to worry about not getting them or not putting the patients on trial. Many -- so we've gone into community, and we're moving into a second community where there's a significant underrepresented minority population and implanted a clinical research infrastructure within that community for early phase trials, which are very, very difficult. Many of these patients have HUSKY, which is like a poor version of State Medicaid. And it's very, very challenging. It's very challenging. So to have the companies -- I know it's expensive, but to have them and not have to ask permission every time you need another pelvic CT, but have it embedded within the upfront budget, I think, makes a huge difference. I don't know about the other -- your operations for Sarah Cannon, what do you think?

I would agree. I mean we also have a Medicare coverage analysis process. I mean this is an active conversation we have going on right now about the philosophy or approach around things like that. It is -- I mean it is a real thing, and I think is that insurance coverages and the types of plans evolve, it becomes an even bigger point of conversation.

Like there was a patient recently that went all the way to the Head of Legal Counsel at the university of my patient, because university CAT scans are more expensive than community CAT scans, apparently. Thank God I've never had to have one. But the fact of the matter is it significantly impacted our co-pay. And she demanded that the scans go into the community setting, so her co-pay would not -- she would have less money to pay upfront. She's no longer working. She's on disability, and she doesn't have the money to pay for these things. If we didn't have to worry about that line item, it would have made, trust me, every 1 of our lives easier because of the legal ramifications that have recently been involved with her based on what was in the informed consent relative to what she is being built for, relative to defining research versus standard of care within the context of that informed consent. So you have to take all of these variables into effect.

Yes. So I want -- sorry. Go ahead.

All right. I'll layer in again. I'm here for the stories. I think 1 of the things that is interesting about if the insurance is covering it and those types of things that people are going to trials for, we've heard from patients that they will actually enroll in a trial because they're able to get different types of diagnostics done that they wouldn't be able to do with standard of care.

Like sequencing again on their tumor and giving them accessibility, ctDNA, which their insurance wouldn't be paid for.

Yes. So that's just something to keep in mind as well, is that's what drives some people to participate in the first place.

Yes. When we try to recruit patients, I think 1 of the first questions they ask us before...

[indiscernible]

Exactly. The first 1 is, would this save -- will this make me live better -- live longer? Is it going to cost me? And our stock answer, we're trying to say, "Oh, no. Listen, everything is covered. Don't worry about it." And then they -- on the back end, it's actually extremely embarrassing and obviously bad for the patients when they -- well, actually, did they charge me for this? Because this visit was a clinical research visit that was my payer. They don't say my payer, but my insurance didn't want to cover it. So that becomes a challenge for patients, and that makes them less likely to accept being included in the trial. And the patients talk to each other. They're in the waiting room. They're on Facebook. They're on social media. And this kind of bad experiences, they may not tell you, oh, I heard from another guy in a Facebook group of leukemia that they actually got charged, I'm not going to participate, but they would just say no. So that's something that I think we're working on doing upfront budgeting, like Dr. LoRusso has mentioned. I think that can go a long way. There has been some progress in that area. I would want to highlight that I think it was in no small part thanks to lobbying from ASCO that the Congress recently passed the legislation allowing Medicaid patients to have their clinical trial visits reimbursed, which, technically, it took an act of Congress to get that done, but it did. So I think advocacy can certainly help patients in this respect. The other thing that I want to mention is, now in the post-COVID world, we all want to use telehealth. I love telehealth personally, and there is challenges in reimbursement for that.

Yes. Now -- absolutely.

If the patients are rural...

Post-COVID, they've gotten rid of reimbursement for a lot of our telehealth visits.

And so not all the trial visits, obviously, Phase I is a different person, man is a different beast. But not all of our telehealth visits needs to be in person. If they're doing well, we can call them or have a video visit. And now with the emergency of COVID gone or most of it gone, a lot of those reimbursements have been declined. We've had issues with rural patients, which are another underrepresented population, and people that live out of state. We have patients that actually have to drive through the state line and then have the conversation in their car on the State of Alabama.

So that you can [indiscernible] telehealth.

Exactly.

Because you have to tell them exactly where the patient is and where you're doing it from.

And that's just...

I'm sorry. You're saying like Medicaid is not reimbursement, and based on that, are you saying pharma is not?

Any payers.

No, no. I'm talking about third-party payers. Not you guys. No.

I mean I think you appreciate the complexity and how layered these issues are. And the fact that there's no 1 -- these can be addressed in the context of a single trial, a single sponsor, and there are many different layers. And so I think that it's really important to have this broad understanding of like what we're actually dealing with and focusing on how to overcome that. So issues around sort of out-of-pocket costs to the patient for the various trial procedures, imaging, test, all of that. We have to think about sort of what can we do as the designers of the trial to limit that, to really answering the question that's germane to the clinical investigation. But in addition, how do we leverage our other sort of stakeholder groups that are focusing on policy to also address that from that perspective? So there are multiple layers to many of these issues that really needs to be uncovered. When you agree to participate in a clinical trial, you talk to your doctor about it and your doctor assures you that this is the appropriate step to take. And then you go and then you don't meet the eligibility criteria. It's very troubling for the patient. And particularly...

It's also troubling for the physician because they have to tell the patient. It is very, very painful.

Exactly. Especially that exclusion criteria isn't really important, right? Like you're being left out because your hemoglobin is 8.8 and it should be 9.

Oh my God. And you have to wait 14 days [indiscernible] transfuse the patient, even though for 6 months, their hemoglobin was 8.5 to 8.8. You got to get it above 9. Now you've got to wait 14 more days. And if you only give them 1 unit of blood because there's a blood shortage and they're 9.2, and then day 1 cycle 1, they're 8.9, you can't treat them any more. I mean it's ridiculous. Sorry, sorry.

I mean it's true. That's all it takes, right? It's like the physician is now on the call with whatever, the CRO, whomever, right, the monitor...

Can't waive it anymore.

Can we waive? No, no, no. We can't. Like the physician has to put time in that. And then the patient, the patient is there, right? They can be on this trial. And you've done all this work and now you've just dashed their hopes, right? So that's 1 thing, so that issue. And then not...

Sorry. Can I just add into that piece? Because it's not -- I mean it's the pharma companies, CROs, it's the policy, it's also the regulators. So I think all of us -- because to your point, if someone is not meeting eligibility criteria, pharma has a lot to answer for why they keep waiving, or even endpoints, or even multiple criteria why they need to keep getting these labs checked. I think it's all of us together holding hands and saying, "This is how we're going to change. This is the data we really need."

Well, I'm almost wondering because some of our patients are staying on Phase I trials a long time. Now I don't do Phase II, III. I don't have the luxury of understanding that world. I only do Phase Is. But the fact of the matter is, when you've got patients now that are staying on a Phase I trial for a year, 2 years, 3 years, which we're seeing, thank God, because of better scientifically-driven drug development, going into like a semi-pragmatic almost after so many cycles or after so much time where the data points that you're collecting may be somewhat different, I don't know. I don't know if it's even feasible with the regulatory agencies to allow that.

Well, we can talk about that, I guess, when we talk about solutions. [indiscernible] about the challenges, right? I do want to come back to this issue around the challenges, right? Because there's that issue that sort of takes away the trust and the patients talk to each other. So that's 1 issue. I think the other issue is around, can you tell me what the -- what's this going to cost me. And I think a lot of people who offer trials cannot do that, right? So that's 1 thing. The other issue that I've heard sponsors talk to us about as we've convened different working groups to understand what their challenges may be has to do with -- and I want to kind of move away from the cost of the trial to some of the data that you presented, the clinical trials being the proportion that are U.S.-based only or that enrolled U.S. patients dwindling over time. And sort of what has been shared has to do with the time it takes to actually initiate that trial at the U.S. sites because of contracting challenges and other things, and there may be other things. I think that's, again, another thing for us to take a look at as an ecosystem, right? It's like, why is it taking so long? And by the time you open the U.S. site, it fully enrolled in Poland and wherever else.

Australia.

Where you're not going to get the diverse representation. And so these are the kinds of challenges that I like to talk about because they're real things that we can identify that are internal, like to the -- that we can act upon at various levels.

I agree with her 150%. I mean activation is an issue with academic centers, especially because of legal provisions in these academic centers. That's why many of the community sites are thriving relative to some of the academic centers. And it's only going to get worse. And unfortunately, the people that are running the academic centers are not clinicians facing these patients on a daily basis. You know you have a drug that has a significant therapeutic potential with that patient, and you've been waiting 6 months, 8 months to open the trial.

Sometimes 12, I've seen.

The average time is 9 to 12 months. An average an academic in the U.S., we planned 9 to 12 months. So yes, it's problematic.

So we've noted that [indiscernible] problem, but I want to move -- and I also do think in future, these panels probably should include a payer to ensure that, that stakeholder is represented. And we'll come back to that.

But how are we going to address the solutions for that? Because I think there's real tangible solutions that we can talk about.

Yes. So let's move to talk about solutions, right? But maybe we'll start with Yasmeen because I want to bring you in and [indiscernible] what we -- we know that there are maybe hard and soft solutions, right? So some of the contracting issues and reimbursement issues are actually rather hard issues, not difficult, but just hard. The softer issues, value proposition to the patient, how we are bringing the patient to -- into the trial and to consider the trial, the conversations that are needed by the sites and so on. So -- and where are we seeing the progress, right? What's the good news that we can talk about that reflects that we actually do know how to have these conversations. We do know how to activate the community sites. We are seeing some progress. Can we share some of that?

Sure. Well, it's happening now because we're having a discussion. I think this is a discussion that has gained, I wouldn't call it, more attention. It's getting the recognition that it deserves. It's not a buzzword. It's not a trend. These are people's lives, right? And so I think we need to treat it as such in terms of just equity and diversity in general across the health care system, and that includes, exactly, clinical trials and clinical research. I do think that what's important is the prioritization of accountability, right? Does it take Congress to ensure that we're -- ensuring that we're making these investments, not necessarily financial investments, but it can be financial investments, human capital investment, whatever? But how do we ensure that we are holding entities accountable for ensuring that equity and diversity is implemented into the system processes, right? So I always say, let's not talk about it, let's be about it. So now it's time to be about it. And we talked about a lot of actions and solutions. And now it's time to talk about how we implement those at the different levels as appropriate, academic sites, CROs, pharma, but also the role of the patient and the role of the community. I can't stress that anymore. Inviting them to be a part of the design of the study. No, they don't have to analyze the data, okay? But it's as simple as asking them, what do you need? Ask them. Even no one asks them. What do you need that will make it easier for you to participate in a clinical trial, right? And perhaps that's going into the community and building some trust, maybe having a focus group, add food. Food goes a long way, I'm telling you. It really builds camaraderie. But let's say you're building this relationship with the community that you might want to obtain data from or have a part of the trial. Start bringing those relationships in early and bring them into the trial design. Not an afterthought. Not after you designed the study. You collected your data and then you realized, "Oh, we don't have enough Black folks. We don't have enough Latinos. We don't -- no, no, no. Start in the beginning of the research when you're designing it and implement those processes in. And perhaps there needs to be some policy accountability for that, and of course, this is dependent on the type of trial and location and all that. But there should be some level of standardization that's more than -- there's guidance and there's recommendations, but we need requirements now. It's time to require. Because if we don't, we're going to still be here. And as I said, it's like the dog chasing its tail, because we are still here. We're still trying to solve this issue. The positive thing, I would say, really quickly, Murray, is that the conversation is being elevated in a multi-stakeholder approach is how I describe my work, but it really does take all of us as a collective, not siloed into here's my research, here's this, here's this, but all of us coming together, including the payers, which they have a great perspective. And 1 last thing I'm going to say just to kind of go back to something we had said earlier. Generally, if you don't have a job, you might not have health insurance. If you don't have health insurance, you might not be able to access the clinical trial. So how do we get those patients enrolled? What are the mechanisms for that, that also meet the bureaucratic provisions to be diplomatic with that? So I'll pause there. That was a long answer, but...

Maybe, Jen, you want to talk about -- again, you talk about your experience engaging with patients and how this communication really needs to occur and how the value proposition of participating in trials needs to play out. What are you seeing that is working?

Yes. Well, thank you for the perfect setup of -- our whole tagline at Savvy is ask patients, like just do it. So I think that's first and foremost. And in doing that, we've learned a lot of things about what different communities are just saying. And again, like there's no 1 size fits all. So you actually have to do the work, trial after trial, protocol after protocol, figuring out even from the first stage of like which outcomes do people actually care about. Because what you do care about, spoiler alert, is highly likely not to be the top priority for patients or family members, et cetera. So first, like what outcomes are you actually measuring? And then you're designing the protocol. I remember there was another meeting, and one of the sponsors was saying, "Yes, we got this -- essentially, this new platform. You can plug in all the ePROs that you want." And I was like, "Oh, please do not do that. Like don't just do like 20 ePROs just because you can." I mean what is the burden to patients?

A Lot.

Exactly. So we regularly walk through trial protocols and recruit patients to give feedback on it and to really poke holes at it. Like that's what I find my job is, is like take the hypothesis that our clients have and be like, "Okay, let's go see if that holds any weight." So really going through systematically like what is that protocol, where are places that you can even add support. Because I know a lot of people come into this being like, "Oh, the protocol is really set." So we're afraid to talk to patients because, oops, we can't do anything. However, there's always something you can do to understand, what additional support? Is it communication? Is it the informed consent? Is it -- they need to know exactly like the emergency contact information so that if they think that they're having an adverse event, they and their family members can feel comfortable. So all of these different things that you can add there. And then the recruitment process. We work with a lot of the sponsors and/or their agencies to get feedback directly on the materials that are being used. And 1 example I'll share is that there was a particular campaign, and sometimes these agencies come to us with like 3 different options. Here's this one, and this one, and the titles are different, the pictures are different, and the patients will go through and give their feedback on them. And there was 1 trial that was recruiting, and it was in a therapeutic area that was predominantly affecting Hispanic and Latin Americans and as well as Black and African Americans. And what they were doing was that they had these like -- it seems like very artistic portraits. But the patients said, the way that we're being portrayed like -- in like a shadow makes us feel even worse and that you don't understand our community. So they're like, I would see this and absolutely not enroll. So these things matter as well. So how are you getting feedback on these materials? So just some examples of the fact that like if you actually do the work to get feedback on protocols, materials and then go into the community early on, that's what we hear from patients all the time. Like don't just come in like, helicopter in, hey, let's recruit you, and then, oops, the trial, we're shutting that down, and now you're never going to hear from us again, like really engaging to begin with.

It's hard. I just want to say that. This is hard. Okay. So let's take it in, and it's hard. So -- and when I say it's hard, we have to work hard. Otherwise, what are we doing, right? We're doing this to obviously overall improve people's health outcomes, including our own. We're all patients at times, too, right? So it's hard work. So I just want to -- it's hard.

Yes. It's hard because it's only part of a much bigger set of issues that we're dealing with.

Absolutely.

But Amanda, I want to come back to, again, the practical reality of running a site, recruiting, screening, enrolling, and again, the progress that you at Sarah Cannon are making in terms of being able to bring in those representative populations.

Yes. I get so excited hearing you guys talk about -- and I think it is very much what we're all saying in terms of it's got to be a collaborative effort across all different disciplines to really make it. I get really excited when we have some pharmaceutical partners that approach us around we're trying to do innovative things. How can we collaborate together? And it's a very bidirectional conversation like not just, hey, we have this greatest ePRO device or technology device that only a portion of the patients can use it. And so I think the innovation around -- like putting our heads together around what can really help is really, really important. And I know I'm not saying anything different than what you guys are, but it's critical to helping the patient have the experience that I know we all want and desire.

So time is ticking by here. And I want to make sure we get to this discussion and -- from the sponsor perspective, right? Because at the end of the day, you are the ones responsible for the protocol design and development for conveying goals, if you do, for representative inclusion. You are the ones that have to submit a diversity action plan to the regulator and get that approved and then execute the trial. And you're part of a business that has business goals as well. So let's talk about, again, where the rubber hits the road here in terms of how you are able to strike the right balance. And even within your organizations, right, how you debate -- I don't know if we want to call them trade-offs because we don't want to suggest this or that. But the recognition is we need -- we do need to move the ball forward here. And so how are you really approaching that?

Yes. I can go first. So I think I alluded to it initially that I think we were at the point 2, 3 years ago that a trial was done. It would go to the agency, and the agency would give a feedback that oh, you don't have the representative patient population. And then we're moving to the stage that even at the Phase I, we have a conversation with agencies on our diversity plan, what is it that we want to see. And that goes at multiple layer. I think the first 1 is just when we talk about the protocol. Let's say we are designing a second line and the patient has to be refractory to [ HNA ]. Well, guess what? Black patients don't necessarily receive that [ HNA ]. Have that conversation with the agency. If we want to do this, what are other avenues open? We have found the agency to be quite pragmatic in those discussions and assembling those diversity plan that apply specifically to the indications and what they were looking for. So that's the first step. And then the second step comes, I think we always say, finding where the patients are actually is the easy part of all the work, is getting that patient to come and be a patient in a clinical trial. And that's what I think this multilayer approach that we're talking about here becomes key, that this doesn't have 1 magic key. This is like everything that comes is complexity, you have to move 1 barrier at a time. The #1 reason we heard from our patients was that nobody asked them to be a part of a clinical trial. I think you've heard that many times, physician education, patient education and clinical trials. So then you can go to this multiple levels, I think. But the fact that we are actually looking at protocols, we're looking at inclusion, exclusion criteria, that this inclusion criteria will exclude Black and Hispanic patients and have that conversation with the agency. And, okay, if this is a must, then this is the impact. Then, again, we have found them to be really good partners in those conversations at this point, and that is a shaping of the environment of discussion around development plan.

I think -- I mean there's always a lot of challenges, right? Because our goal is to develop medicines, get it approved and get it in the hands of patients, and you're racing against time, particularly in oncology. Our patients die. And so you're trying to move fast to get it there. And then a lot of times, internal discussions play out because you're saying, "I want to make sure that my trial represents the people who actually have the disease." And then you know there potentially may be a lag in terms of getting that drug approved and recruited. But I think there's a lot of practical things we've done to -- I'm going to talk just industry-wide, to change a lot of those things. So we're talking about, for example, protocols and inclusion/exclusion criteria and making sure the patient's voice are there. I can tell you, we have something called protocol design lab for every single protocol. And that protocol design lab includes the patient, patient advocacy groups, the team, the physicians coming together to make sure that, that protocol is designed with the patient in mind. Because in the end, that patient is the 1 that's coming on the trial. And again, like I said, resetting your baseline consent forms. We've done so many things, to me, that I wouldn't even call innovative, but practical. We have 8 consent forms. Why can't the patient take the consent form home and go through it with their families and then come back and have that discussion? Why can't we make sure that all the consent forms are in the language that the patient speaks. It's a tiny budget to do that, but a lot of times, I'm learning that it's not even in your upfront contract. So a lot of institutions have to swallow the cost and they get reimbursed. But those are little things just to make sure that patients understand the study that they're going into and actually can make an informed decision. And then we talk about the recruitment challenge. Let's be honest, everyone has their own biases, and we need to acknowledge that, and we need to make sure that physicians and the sites actually are educated. Like I said, we mandate now that if you want to come on our trial, you take some kind of quick course to make sure that we've upscaled you in terms of what can your patient population look like? How do you engage? How do you interact? And then go a step further, retention. How do we make sure that the patients are comfortable with the study and we retain them? How do we make sure they understand what to expect during the study? How do we make sure that we're speaking the language that they understand? And so there's a lot of things that you can and we do to make sure that happens. We talked about going into the communities and upskilling the physicians in the community so that we set them up for success. We're pumping a lot of money in there. And my biggest fear, quite frankly, is that you're talking about an infrastructure change that cannot be temporary. And there's a lot of talk about it right now, but my biggest fear is that it's going to start dying down and we stop pumping money there. So how do you really create sustainable infrastructure across the community so that they can go to their research? How do we make sure that patients are getting the dollars upfront and not reimbursed and so they can travel? How do we -- I mean so all of those things we are doing to make sure that we can improve. And then we hold the sites accountable. If you tell us that you're going to recruit x amount of diverse patients, we build it into your contracts. You need to make sure that you do that. And we -- and there's 1 study we held open until we recruited the right amount of diverse patients. And I mean you take a financial hit with that, but it was worth it because if you found it, if you say you want to do it, I think you hold firmly dig your heels and you don't move until that happens. And then slowly institutions, sites will understand that you mean business. And if they don't recruit the diverse patients as promised, then we reassess whether we're going to continue to do business with you. But you have to take it seriously, and those are some of the things that we're implementing to make sure that we are taking it seriously. And then hopefully, over time, we can start seeing that recruitment because we've now set a new [indiscernible].

And when you talk about pumping money and the infrastructure, are you talking as 1 individual company doing that? Or is it being done collaboratively? And what's the nature of that collaboration?

It is being done collaboratively. There's a ton of different collaborations across pharma companies, patient advocacy groups coming together, institutions coming together, to look at the big challenges and seeing where we can invest together to solve them. So initially, you started seeing these different companies doing all these solo things, and it doesn't make sense. So what we're trying to do is come together as an industry and say, "We're going to solve this problem together with -- side by side with the institution, side by side with the patient advocacy groups, the patients, the payers, but pharma, in general, coming together to do it." And like I said, I've been in the industry for a while now and I would say, over the last, what, 3 years, I'm seeing just a big change in terms of investment together.

So I think that in the past 3 years, there has been obviously increased visibility of this issue, and everyone wants to just putting in their effort and their resources, and I think that's great. I do think that there's a need to maybe sometimes step back a little bit and make sure that we're not duplicating efforts. That they're not overlapping. Because in all of this, I hear -- when I hear companies that we're going and we're asking for accountability at the site level, and we're asking for this, and we're giving the money, and I think that's great, don't get me wrong, but it's the same sites. And so now you have Dr. LoRusso and her colleagues have to take the GSK training, the BMS training, the Merck training, all these company trainings. It's not sustainable, right? And also, you showed a lot of information about the number of oncology trials, right? So most of which are going to the same places. And so I think that there is really -- it's really important to really be having this conversation in the context of going where the patients are in a different way than we have in the past. So even if you are activating your site, your community sites that may be affiliated with academic hospitals, that actually having those sites be where the trial is, not at the large academic center. But I have a lot of concern really about the sustainability of what I see happening now because there's a lot that's being put on specific types of stakeholders who may not have the capacity. I mean we have workforce shortages at the large academic centers everywhere.

Nobody has addressed that. But 1 of the reasons for activation time lines in part and delivering, we lost a large portion of our workforce during COVID. We lost that workforce at the academic centers to CROs like IQVIA and pharma companies like GSK. That's the reality of life. Why did we lose them? Number one, they could increase their salaries conservatively by 50%. Number two, they had more of a hybrid model, a work-at-home model, which we're going to, but what about the increasing salary by 50%? One of the problems we have is retaining talent. Institutional memory is crucial to getting the job done right and delivering to the sponsor good data in a timely fashion. We need to be able to reimburse our people so that they're not stolen within 3 to 4 years after we spent an enormous amount of time training them. And that is also going to help recruit diverse populations as well. Because they understand the need, they're at the point beyond the quick learning or the early learning to be able to understand now the problems that we're dealing with at hand. But instead, we're cycling to train them for CROs and the pharma. We need to be able to pay them equitable to pharma and CROs. You guys, you're at Sarah Cannon. You're at Alabama. Do you agree or disagree with me?

Oh, 100%, but I'll actually tie the 2 things you guys are saying together, because the other component of that as to why colleagues will leave to sponsors and CROs is because then they have a singular focus or requirement on trainings and things like that. [indiscernible] 900 different sponsors...

[indiscernible] training. Every company has a different GCP training. Do you know how many GCP training -- no, no, no. This is real. We should have a general -- IQVIA Institute can do this. Set up a set standard of training sessions that can be universally used throughout multiple different sponsors.

But that's the discussion that we're saying we are actually having. So when we said that the pharma companies coming together with these types of CROs to say, it doesn't make sense. To address your point initially, where you said there's different physicians doing different [ DEI ] training, that is so true. And so we had it -- we've been having a lot of conversations and saying, how do we just stop having individualized types of programs and lean on, like you said, like IQVIA to come in and different areas and say, let's create a universal standard that we all align on and just leverage that.

And I'll accept.

Yes. Exactly.

Because it's not just I feel like giving you different GCPs.

Because it's a bit about that also. We're -- amount of money we're putting in for individualized training, it doesn't even make sense to do it that way. So I think, again, within the last couple of years, I am noticing, for the first time, all of us coming together to just have that conversation and saying, how can we do it instead of let's just have our own tunnel vision. And that's the big switch that I'm seeing recently.

And that's not just a diversity issue, it's a trial and capacity and efficiency issue.

I would say 1 of the stakeholders that is also not represented on the stage are the small biotech -- smaller companies, which do, all due respect, to large pharma, but actually, most of the oncology assets are being brought through by small companies that don't have the resources, don't have the buckets of money necessarily. And I think we also miss a point by not reflecting on how this plays out.

They tend to be more conservative in their recruitment strategies and their inclusion criteria. And it's basically a matter of the bottom line. But the other day, their business, they're trying to make their numbers work. And any kind of perceived threat that would make them -- they usually have 1 or 2 products only on their trial. So if the trial is negative, then their stock goes to 0 and they cease to exist. So I think it's harder to bring them into the fall, but we should make the effort.

Right. So as I was saying Tania, talk about all this great stuff, right, that's happened since I first started talking about the GSK 2018, right? And I know you guys started sooner. So the small biotechs are in a totally different ballgame. And I think as great as all of this that we've talked about, if we don't help them understand how to do the diversity planning and see that it's an incremental improvement, that the -- again, the consternation around goals is because it looks like it's a past fail. It's a requirement. If you don't mean it, you fail. We have 1 product, but you also -- if you can't get it to market in time. FDA has done -- I think your guidance is clear. I see it, but it is not there that way, and I try to advise sponsors that way. But I think the more advocacy around this is about setting your sights on doing -- your sight -- your goal is to do better, it's about investing in the community and collaborating. And all these great things we talked about, set it and do better and get there. Because once you understand your population and you start to deploy strategies, you can learn. You learn about your population, you learn what works and you refine and you do it again. And that would be my last point about the learn and refine again. I love hearing about the inclusion/exclusion criteria that doesn't work. We can look at our data and identify some things. But until we engage with the physicians and hear that, and collectively, if there is anything that can be done from the central level to share what those hurdles are inclusion/exclusion criteria-wise, I think that would do a huge thing.

And your database may not have all of the information you need to know to better understand that, because the patients may not even be screened or consented because they don't meet inclusion/exclusion.

And nor do we -- is there a central place for what screen fail? What's happening? Why did all these oncology patients -- I've heard about the folks who get a lot of diverse patients in and have screen fail. And their percentages are great on the recruiting -- or bringing to the screening stage, but terrible at enrolling. And it's not the ICF form, it's not trust, it's not any of that. It's got to be the I/E criteria. So how do we learn from that? So the next time there's a trial, they do it better.

The diversity plan is the end product of a lot of work that has to happen behind this. It is not the thing, right? It's just the thing that tells us what we are doing, how you're thinking about it. So there's this kind of focus on like, "I'm going to get my diversity plan, it's going to look good and the regulators are going to agree to it." But at the end of the day, it's really how you implement that strategy that's going to yield the results that you're looking at. So you can have a beautiful diversity plan, and it means absolutely nothing if you don't actually do the work behind the scenes that is required to actually meet that. And as we talked about, it includes many different things that you have to look at your own internal data, your own past performance on clinical -- the sites you have relationships with, the ones you want to establish relationships with. There are so many areas, and we didn't even get to the ex-U.S. experience today. But that's a huge part of this that is a huge barrier, I think, because the sites that are chosen ex-U.S. are not chosen deliberately to deliver on data that are applicable to the U.S., in my opinion. I think that those sites are chosen haphazardly maybe because of cost, maybe other considerations that I think we need to get into. Yes. I mean the ease of getting the patients funneled into that because maybe they don't have as much access to standard of care, and so this is very attractive. There are many issues which require a whole other discussion, but that impedes upon the ability to enroll these representative populations, and we have to talk about that.

Right, right. And unfortunately, we are not going to get to that today now because we're over time. So this has been a terrific discussion. And I don't want to say we need to discuss more, but we do. But I think this has been very positive, I think, in terms of the recognition that things -- we're having a different discussion than we would have 3 years ago. That's good news. Maybe I can just go down the line with just a final parting thought or could be a call to action or something that's occurred to you during today's discussion that you take away, final thoughts.

What I want to take away is I compare the industry where we are now to how the car industry, actually, they share all the safety information with each other. So actually, we all learn from each other to get to a common cause and come to a point. And this aspect, we're all figuring it out together, and we're sharing that information together to get us there. So that...

Okay. Great. Tania?

I would say, clearly, all of my colleagues here, we are all aligned that this is a health care crisis that we need to hold hands together to solve. And while all of us -- I mean -- and I think I'd get 100% backing in this, we all have the same goal, is to get these drugs to the patients that have the disease and in a way that they can receive it and get it and actually improve their outcome [indiscernible]. Now all of us have our different functions in which we operate. But the only way that we can make this successful, the only way we can improve health outcomes is we come together, hold hands and do it together to make sure those patients get access to our drugs. So I would say I enjoyed this conversation, and I'm really looking forward to getting to know a lot of you more and seeing how we can collaborate and deliver this for our patients.

Rachael?

My takeaway is, first of all, sitting next to you is inspiring and interesting. I think my takeaway here is the tremendous progress we're seeing on 1 hand. And frankly, it juxtaposed against the tremendous challenges we see in sponsor conversations internally. But there's hope here, and I think that the collaboration, hearing from sites, patients, investigators, some of your stories are just -- have been so profound and then, again, the collaboration with regulators. Like you said, it's -- you guys are there to help make this a reality. So there's, I would say, a lot of hope more so than just a conversation about what the problem is. So I like it.

I would completely agree with that. And I feel like the call to action is, how do we keep this conversation going? And not just -- I think we -- somebody said at the very beginning, not just the conversation, like how do we make actionable change, and it's not having a conversation intermittently. I mean we have to identify what those actionable pieces are, and we need to do it together.

So I feel like I'm cheating because I kind of had mine at the beginning. But I do think that there is -- there's really a lot of opportunity here for a public/private partnership, consortia, establishing consortia that work on these issues, these multilayered issues on an ongoing basis to continually address the challenges that we encounter and sort of resolve them. I completely agree in collaboration. And I think that all the stakeholders need to be at the table to do this. It's going to be very hard. We're not going to be seeing tangible differences in a year or 2 or 3. Like the reports are still going to look horrible next year and the year after that. And that's -- and so we just need to be prepared for that and not sort of say, "Well, we've done all these things, and we don't see any results." So I do think we need to have ongoing work together with all of our perspectives, taking into account to address these multilayered issues. And I think we have to have patience and humility. We don't know what we're doing. We don't know that what we're doing is going to lead to success. I think we're choosing reasonable approaches, but there's no blueprint. And I get sort of triggered when I hear best practices because we don't know that either, until we can see that all the collective actions we're taking actually lead to improved clinical trial represented in this. Thank you.

Manuel?

Yes. Thank you. I agree that this is a collective effort that different stakeholders should work together. What I wanted to add is that this is also -- and this is something that maybe not be perceived by everybody, but this is also scientific. This is also -- like this is not only something that stands either in contrast to or separate from the scientific endeavors. What we're seeing is that understanding really the molecular mechanisms of cancer really requires different types of cancer patients even when they have the same malignancy. And I think that's something that has been overlooked, and that -- now that we're looking at not only the cancer cell, but the tumor macro environment and how pharmacogenomics, all those things are going to be positively impacted by our efforts. And the other thing, building on what Lola mentioned, is that we have to be sort of honest with ourselves, right? Establish clear benchmark for success. And when we fall short, we have to come out and accept it, right? Okay, we fell short here. What can we do to improve? Just avoiding -- it's very easy to be self-congratulatory. Certainly, I like it, but sometimes it's not the best for moving things forward and progressing.

Jen?

My call to action is always the same, to ask patients and work with them. But I'm going to sneak 2 other things that I want to make sure get into this conversation. I would be remiss if I didn't say them while we're here. I think in our conversations around diversity, a lot of it tends to be race and ethnicity and thinking about it that way. And we work a lot with the LGBTQ community, and I think especially those who are on hormone therapy, making sure that we're understanding how we can include them if we're talking about these types of trials. Thank you for calling out the science of it. We need to understand how this works because they say, "Hey, I'm getting excluded," or, "I don't know if I can even be on this drug." So there's that part. Also, we haven't really talked about it. We talked about the financial aspect, but please compensate your trial participants. Not just reimburse them, but actually compensate them for doing the work, taking the time away from their jobs, their family responsibilities. And I think that sometimes goes undiscussed. So I'm here to just leave you with that.

All right. 3 key points, but you got my mind running wild, because I just second everything that you say, particularly with the compensation. Early in my career, I was a program coordinator at an academic facility for many years. I've had that institutional knowledge. I think it's important that we really do focus on the workforce. So your point is very well taken. And this is important. The clinical trial enterprise is a great opportunity for professional development, for career, all of that, so I think focusing and investing in that financially and human capital. I think the pandemic also shed some light on the benefit of public/private partnerships and what they can do. So I think that's the positive that's come out of sort of the pandemic and what we're learning today, but now also how we maintain and sustain this for the long term. And then the last thing I'll say is, go big or go home, meaning let's do this and keep moving.

I think the underlying problem is equitable health care. I think clinical trial participation and diversity is 1 small part of it. I think that we need to address both. And if we only address one, we'll never solve either. I just think it's really, really important. And when we're talking about finances, it's more than just what we're reimbursing the patients for the health care providers are providing within the context of the trial itself. They're people. They're human beings. The populations that we're discussing today, many of them are living paycheck to paycheck. Taking a day off work, taking -- driving to a site, paying for parking, trying to identify where they're going to get food on their table, even because their diets are altered because of the treatment that they're on, are huge issues. And we need to really look at those social and structural determinants of health, dissecting them, realizing that each patient has their own unique problems. And until we address patients as people that are trying to survive, I don't know that we're going to solve the problem.

Great. Well, with that, thank you so much to all of the panels. This has been terrific. Thank you to the audience for being here in person or tuning in. Do visit our website if you want to download any of those reports or opt-in -- or join our opt-in mailing list so you get informed of additional work that we do at the IQVIA Institute. But with that, I want to thank [indiscernible] and the team for arranging this session today. Thank you all, and I hope everyone has a great time over the next few days here at ASCO. So thank you very much.