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DE&I

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Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses:

Industry’s greatest challenges in reaching diverse patient populations

Podcasts

Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more. 

Reaching Diverse Patient Populations With Personalized Treatment Methods

Examining the implications of the recent US executive orders concerning diversity, equity, and inclusion pursuits—and the key questions each clinical trial stakeholder must now navigate.




The Impact of DEI Ban On Clinical Research Ecosystem 

Research collaboration between Tufts and the Society for Clinical Research Sites explores the prevalence of this belief in healthcare.

What Does Racial Color-Blindness Mean for Clinical Trial Participation?

Recent research is showing medical treatment for pregnant women often relies on clinical data from non-pregnant female patient populations.

Pregnant Women: An Underrepresented Group in Clinical Trials 

This year’s conference highlighted a number of critical areas in clinical R&D including financial management, representation, and eCOA. 

Notable Discussions from SCOPE 2025: Aiming to Calculate, Accommodate, and Innovate for Enhanced Drug Development 

Addressing systemic barriers and biases faced by women in research to foster a more diverse talent pool.

It’s Time for the Life Sciences Industry to Accelerate Action for Gender Equality

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses numerous themes that clin ops can focus on to keep its trials running efficiently and effectively.  

Areas of Focus for Clinical Operations Leaders in the Current Research Climate

, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the impact of recent regulatory decisions on clinical research. Funding cuts by the NIH will affect intramural research and shared infrastructure. Additionally, the politicization of diversity initiatives will affect the enforcement of action plans. Lipset also highlighted the industry’s response to these actions and what it can expect moving forward.

ACT: From a clinical operations point of view, what does the industry need to focus on to ensure trials remain efficient and effective in light of some of the recent government actions affecting it?

One theme I would say is we do need to save our sites, but in the year 2025 our attention has to be on US academic research. We can't abandon them now. We have to be a little patient with them right now, so we shouldn't start reallocating our research portfolios away from academic sites and shifting studies, in earnest, more towards private, free-standing sites, which are great ways to mix a study, for sure, but our academic sites are going to face a resourcing challenge. Many of them have hiring freezes. They're having to reshuffle a lot of their own budgets right now. It's a challenging time for them, and not a time for industry to turn away. We need them to be sustainable, and we are going to have to be an important part of that sustainability, so be patient and stay by the side of America's academic research infrastructure.

Diversity and representation investments; hopefully we've learned enough and we can continue to share enough in this space that we can be efficient in realizing representation. It still will take extra effort in planning, but hopefully we can sustain our work there, because we could do it in smarter and more efficient ways.

Certainly for clin ops friends, the regulatory environment will remain somewhat unpredictable. There are regular changes happening on websites, on nights and on weekends, and we don't have email communications or newsletters coming out that are summarizing those yet. There is a certain level of unpredictability, and that unpredictability will continue with turnover and leadership. Will turnover in leadership with the inspection community in FDA bring consequences in terms of what inspection readiness looks like? We just we just don't know yet. I would say a last call for folks will be being mindful of possible changes to Medicare and Medicaid coverage, and realizing that that has consequences for research participation. When we do coverage determinations in our protocols, and we have decided that certain procedures in the site's study budget are not going to be paid for by the sponsor, but are expected to be covered by the patient's insurance, we may have more patients who are being exposed to cost sharing or who may have coverage gaps as a result of some policy changes this year, so this is a very important year for us to make sure that we understand ways that we as sponsors can help to cover these costs, so that we are not neglecting uninsured or underinsured patients and preventing them from being able to participate in trials simply because we've done a coverage determination where we thought an expensive CT scan, MRI, or routine care chemo was supposed to be covered. We need to make sure that these patients are being kept whole, and there are some very smart and innovative folks out there that have been figuring out ways to do so.

Videos

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses how companies in the clinical research industry have been responding to recent political headwinds. 

Industry’s Response to Recent Government Research Changes

ACT: In your view, how has the clinical research industry responded to the recent regulatory decisions impacted by the federal government?

I would say that for the most part, industry has been pretty silent on a lot of these decisions. One could say that industry has its own concerns to have to navigate, whether it's around regulation and the pathways for demonstrating efficacy and safety of new medicines with FDA, or whether it's around pricing and reimbursement, including IRA-sparked negotiations with CMS around pricing, so one would say that the industry is maybe deliberately staying somewhat silent out of maybe a perceived need to protect themselves and other interests, so you don't see a lot of industry muscle being used to speak out or defend funding and resourcing at the FDA or NIH, as an example. I think most of many of these companies have followed the lead of others and started to modify language on their websites around diversity in clinical trials, but not all. I think we'll start to see some separation in terms of how industry responds with regards to that commitment to representation. It's still a mandate in Europe around diversity and representation, but the targets are very different than what our targets look like here in the US.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses how the current political climate is affecting diversity in clinical research and how diversity action plans may be impacted.

Addressing Current Regulatory Challenges with Diversity in Clinical Trials

ACT: What was your initial reaction to some of the most recent regulatory decisions impacted by the federal government such as NIH funding cuts and the FDA removing its diversity webpages?

I know you're also asking about the impact around clinical trial diversity and as we see websites coming down with certain language, in some ways, maybe it's all of our fault, right? Maybe we shouldn't have been calling this clinical trial diversity in the first place. Maybe over the last year, seeing some of the politics around the term diversity, we should have taken the warning and started to refer to this more around representation and research, because representation in research is more scientific than social and is certainly something that many of us can back and defend. Now, I think for those that follow the confirmation hearings with the likely incoming FDA commissioner, it was nice to see some reassuring messages from him about clinical trial diversity and representation. Now, I have some friends that will say, this is codified, this is law, diversity in clinical trials, so therefore it will persist, but I think for those folks, I would encourage them to read the law and read what the draft guidance has to say. Companies have to create diversity action plans. The FDA doesn't have to take action based on a diversity action plan, so there is discretion within an administration in terms of what kind of action or consequences there would be if a milestone in a diversity action plan is not realized. In some of the draft guidance language, it might mean that one has to do more real-world evidence gathering to understand other populations, but the consequences, at least in the United States, aren't hard coded with drastic penalties, so there is a fair amount of discretion to be had there.

I do fear personally, that without a regulatory mandate, a lot of our investments and commitments related to trial diversity will slide backwards, enrolling representative patients costs money and takes time, and as a shareholder-fueled industry where pharmaceutical and biotech companies have responsibilities to shareholders and how they use their dollars, will that entire community continue to believe that putting dollars into representation and allowing more time for more representative patients to be enrolled is the right way to use their shareholders’ resources, if there is not a regulatory mandate to do so, as compared to allocating those dollars in other places. I think we'll start to see separation out there where some companies, perhaps maybe those more out of Europe or in other pockets, will maintain that commitment, and others will slide back.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, highlights the need for a satellite model in bringing clinical trials to more rural locations. 

Increasing Clinical Trial Diversity with a Satellite Model

, Iddo Peleg, CEO and co-founder at Yonalink, discussed the impact of recent FDA and NIH actions on clinical trials. With changes in funding and DEI initiatives, there is a need to make trials more accessible for patients. Peleg highlighted how advancements in technology could address this, not only increasing accessibility, but efficiency as well.

ACT: How do you think the FDA removing its diversity webpages and the recent NIH funding cuts will affect the operational aspect of clinical trials in the present?

This is very interesting, because when you're thinking about the main challenges that we have in clinical trials, only 5% of the Americans have access for clinical trials, so basically, a clinical trial is the care option. It's not an option, so the steps need to go in order. How can we facilitate? How can we impact the operations in clinical trials, and eventually, what we want to be in is a place that the change will be shifted. Meaning right now, the majority of the clinical trials, are done in the big institutions in the big cities, we want that everyone will have a chair next to the table of clinical trials and all types of activities that are promoting this type of diversity in a clinical trial, meaning going to different geographical places, to go outside of the big cities, go to the rural areas, go to the neighborhoods. I think this is critical and this one will generate true diversity in clinical trials, and it will make clinical trial accessible to any patient. I will say more than that, when we are saying only 5% of Americans have access for clinical trials, this dramatically impacts the recruitment in clinical trials, because not everyone can, so it's very hard to enroll patients. You have dozens, maybe hundreds of different companies for prescreening and to increase enrollment, so this is a huge, huge problem. I think basically what we need is to be in a place that we are going to the to the satellite model and I think the FDA is starting to go in right direction with it, meaning we still need to have the site of excellence in the big cities, but they are going to be the hub, and then you can have dozens of small sites outside of the big cities. They can bring the enrollment, they can bring the diversity, and the operations and the new guidance that hopefully will be issued can impact this approach.

Diversity Bans Amid NIH Budget Cuts

ACT: In addition to the NIH funding cuts, how do you see the clinical trials industry navigating other political challenges, such as the diversity bans?

Researchers will have to add an extra layer of consideration to something they haven’t really done before. They now have to view their trials through a more conservative lens. When conducting research to solve a problem, one would expect the process to be objective, but unfortunately, that’s the reality we’re in now.

This entire situation is disheartening. It could halt many clinical trials focusing on minority groups and stifle progress on certain vaccines. This could lead to entire sectors of science receiving neither funding nor attention. I don’t think we fully understand the magnitude of this yet—it won’t be clear until it actually happens. It’s ironic in a way, but an important question must be asked: What happens when others refuse to innovate? I believe those innovators will leave for places where they’re welcome. Unfortunately, if this continues, we may see a significant exodus of talented scientists from the U.S. over the next few years. I wouldn’t be surprised if many relocate to the EU, Asia, or other regions where scientists are encouraged to be more creative and address critical needs. Regardless of funding, these scientific advancements remain necessary and demand attention.

The future of NIH-funded research is facing significant uncertainty due to changes in funding policies under the new administration. A major issue is the reduction of indirect cost reimbursements, which cover administrative, regulatory, and overhead expenses, from 50% to 15%. This shift, currently halted by legal challenges, threatens research institutions’ financial stability. Additionally, a freeze on grant proposal reviews via the Federal Register has further complicated NIH’s funding process, requiring researchers to seek alternative funding sources, primarily from the private sector. However, this shift could create a highly competitive environment, potentially stalling critical research in areas like cancer and sickle cell disease.

Political challenges, including diversity-related restrictions, further complicate clinical trials. Researchers may now need to approach trial design with a more conservative lens, which could hinder studies focused on minority populations and vaccine development. If funding and regulatory barriers persist, the U.S. risks losing scientific talent to more research-friendly environments in the EU and Asia.

While some court rulings have temporarily allowed NIH to continue research funding, long-term solutions would require Congressional action. However, given the current partisan landscape, legislative intervention to secure NIH funding against political interference appears unlikely. If the administration defies court rulings, it could create a constitutional crisis, undermining the checks and balances of the federal government.

Beyond NIH, new reciprocal tariffs could disrupt the pharmaceutical supply chain, particularly for raw materials sourced internationally. Many commercial contracts include clauses that could be triggered, nullifying agreements and exacerbating supply shortages. Given the executive branch’s broad authority over trade policy, tariff changes could increase prescription drug costs and create economic instability. With Congress unlikely to reclaim tariff-setting power soon, the full impact remains uncertain, necessitating a “wait and see” approach.

 to watch the entire interview on Pharmaceutical Executive, our sister publication.

Ron Lanton, Partner, Lanton Law, discusses the impact of diversity bans and political challenges on the clinical trials industry. 

Video Series

The Impact of NIH Funding Cuts and Diversity Bans on Research and Talent Retention

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, shares his thoughts on the current climate of clinical research following NIH funding cuts and the removal of FDA diversity guidelines.

Making Clinical Trials More Accessible in Light of Recent FDA, NIH Policy Changes

ACT: What was your initial reaction to the FDA removing its diversity webpages and the recent NIH funding cuts?

When we're looking at clinical trials and when we want to think about if things that have been done are right or wrong, we need to look at the big picture. The number of clinical trials that were done in 2024, it's similar, or even less than in 2019. This means that in five years we didn't have any market growth, which is quite weird, and we need to find out why. We had some jump during COVID, but this is not the reality, the pandemic, when we talk about year-to-year growth. We need to think, what is the reason that we do not see growth in the clinical trial market, that there is a different reason for that. I think one of the things that's very important is to think if we had all types of roadblocks, something that prevented from the market to growth, and to shift the efforts of the FDA, of the NIH, to the right things in order to generate growth of the market, to make more clinical trials, to bring more new therapies to the patients. I think the aim is, when we are thinking about what the best approach is, is eventually to make clinical trials accessible to any patient, anywhere in the United States, so definitely we need to change things. All the changes, I think we need to make them, to make sure that all of them are with the aim to generate more clinical trials, to bring more therapies to the market faster, and to make clinical trials accessible to any patient anywhere.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Tenaerts, chief scientific officer, Medable, highlights the recent findings and how decentralized elements can improve access to underrepresented populations. 

SCOPE Summit 2025: Pamela Tenaerts of Medable Discusses Research From PACT Consortium Linking DCTs and Increased Diversity

ACT: Could you share your thoughts on the recent 

 from Tufts CSDD’s PACT Consortium linking the use of decentralized elements to increased diversity?

 I'm really proud of Medable’s support of the PACT Consortium. What we set out to do is to collect data on what using technology and decentralized elements in clinical trials would do and after analyzing about 70 trials, 20 of which do not have a database locket, so we don't have full data, we learned that there are some changes in the representation of the trials that use decentralized elements, and what we're finding is that we might have better access to certain groups of people that we know need to participate in trials, because the rule of clinical trials is that you should study the medical product in the people that live with the condition. Historically, we haven't been that great at it, and this is the way where we've learned that Asian populations are increased when using decentralized elements by about 50% from 14 to about 20% and that Alaska Natives and American Indians were actually almost four times as represented in clinical trials when using DCT elements. What we're learning is that we probably need to tailor the DCT element to the different populations we want to reach because, for example, African American participation was increased when you look to use local labs, so it's not going to be every element getting you better representation of everything, but what we're finding is that—and that was the goal too—is learning what the best fit-for-purpose solution is to get you what you want. The good news is it's not a binary decision you have to make, you don't have to choose for reaching the right populations. We also learned that when you deploy technology, actual timelines actually beat planned timelines, so there's an incentive for speed as well.

Latest Conference Coverage

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, discusses some of the key ways that different trial sponsors may need support in meeting diversity expectations. 

Supporting Clinical Trial Sponsors in Achieving Greater Diversity

, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of diversity action plans in clinical trials. Fones emphasized the need for understanding the intent behind goal setting, the ability to stay updated with FDA guidelines, and the importance of a robust population assessment.

ACT: What are some of the key ways that you are seeing small-to-mid-size pharmas, biotechs, and medical device companies may need support to meet expectations and make tangible progress in improving diversity in their trial programs?

So much of the work that we do in advising sponsors on diversity action plans and how to meet the expectations of the FDA in context of their overall trial goals or overall program goals, is really helping them, the individuals within the team, who are all coming at it from different perspectives, really understand not just the why from a social justice standpoint and health equity standpoint, I think everybody understands that, but what the intent of the goal-setting and the process and that truly, this is not just about the numbers, it's not just about improvement. It's about learning and it's about showing the work, putting in the effort, exploring the populations and what the impact might be, so that you can then set those meaningful goals. I don't know that you could say that this is a difference between small, medium, and large because we're all talking to individuals within a sponsored company. It just might be the difference of where that sponsor is in their journey and where the individuals are and understanding this, but it's really important to help the operational people feel comfortable that what's being set is achievable. It's helping the regulatory team that may or may not have experience on this, fit this in with other regulatory documents. This is not something that's set in stone, it is evolving. It's really marrying that. Where did the policy intent for setting goals and doing the diversity action plan come from, and then how does that work within the context of your trial? Being able to answer those questions and help the sponsors proceed with that confidence, that what they're setting is meaningful to the efforts that's acceptable to regulators and achievable for their operational teams is really a key value add that we can provide.

What we're going to see is, with it becoming required, is the volume of diversity plans will, of course, match the volume of your trial. Some sponsors may have several trials launching at once and not be able and by several trials launching once, maybe one promising product that they're trying on different populations, which will necessitate different population assessments to get to those goals or they only do one every year. Being able to utilize and tap into others who do these on a regular basis, we're able to stay on top of what the FDA is saying and what they're doing, and again, marry it with what we already know and what we're seeing, and leverage those efficiencies. That said, doing the diversity plan efficiently is great if you don't have that cross-functional team and SOPs built up to do that, but really doing it right to get your trial on the right track and bring that value-add is where I think it's really, I found, it's really helpful for us, even working with large sponsors, everybody's approaching these differently. I think we're all learning from each other, but I can say, our approach to that population assessment is really robust.

Lastly, like I said, it's a moving target. It's going to continue to change. Different reviewers are going to have different feedback. It's really important to understand those nuances, and we at IQVIA have been in a position that if we work across different sponsors, we're able to leverage those insights and deliver plans, again, that are built specifically for the sponsor in that program, yet are acceptable to regulators and implementable on the outside. Hopefully, as this gains traction, what we will see is all sponsors and folks involved in drug development start to see that value, gain that comfort with diversity planning, and it just becomes business as usual.

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, highlights the use of real-world data in setting population goals.

Identifying Clinical Trial Diversity Goals With Imperfect Data

ACT: How can sponsors confidently set diversity goals for trials with imperfect data?

Setting goals and finding the data to do it—I mean real-world data, especially, has so much value, so much value to planning and is so important, and there's growing sources and value in the real-world data. At the end of the day, though, data on population goals is not something you just pull from a database. It's not something that will ever be perfect and exact to your population, so we have to remember, that real-world data provides great insights, but it informs, it doesn't necessarily answer what your goals should be.

One of the things we've seen in our conversations with sponsors, and also in the broader conversation among advocates and industry, and my peers across other organizations is there's consternation around the data; how do you find the population data? Goal setting based on real-world data, based on epidemiology data and public data sources, it's widely acknowledged that these data sources are imperfect, often not granular enough to get to the specifics of your intended use population. While this is something we need to continue to pursue and improve data sources and improve techniques, I think that it's important to realize that real-world data will inform your goals. It's not going to answer your goals. That needs to be that full exploration of the data in the context of the disease, in the context of your trial, but we also need to think about it's understandable that sponsors and individuals within sponsor teams may feel some consternation in moving forward with imperfect data. Setting a goal, committing to a number with a regulator is intimidating, especially if you're concerned you can't reach that goal. On top of that, you look at enrollment sub-goals and enrollment in a trial where you're already worried about getting that complete is also concerning. What we help sponsors do, and often do, is really talk about them understanding that this isn't a pass or fail exercise. It's not what is the answer from this the data that that is the perfect answer, and then how do we get there and what happens if we don't? It's really about understanding that population, understanding those characteristics, setting a goal that is meaningful in context of that disease burden and differences in outcomes; meaningful, but yet achievable, and that's where really understanding the real-world data in context of your use population. If it's pre-metastatic, but second-line therapy, that is a bit of a difference from all breast cancer, for example.

Again, real-world data informs, but it doesn't answer it. Diversity and that population is specific for your disease area and for the trial, so what really is important is the ability to look at different queries, understand what that story might be, what the rationale should be to setting those goals. Then, the final piece of this is we all need to realize there's going to need to be some flexibility in learning as we go along. We can think that population looks like what it is, but there may be some learnings as you go along that perhaps that genetic marker, that for which there wasn't a lot of real-world data, maybe it has an outsized effect, actually, maybe it makes your population more available. The goal here, if we think back to the goals of diversity overall, again, it's not just about increasing participation and access to the trials, though, very important. It is about learning and feeding back. If we learn that one genetic marker impacts one race differently or more prevalently, that not only helps you develop your drug better, but it helps advance the science, advance the practice of medicine, and advance new therapies. I think also the more that sponsors and all of us in drug development see where some differences do and do not come into play, that this whole effort will not seem so foreign. It will become an important part of drug development and pay that benefit that that upfront exploration yields better trials, faster trials even, and more commercial and healthcare success.

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, discusses the importance of goal setting in the context of FDA’s latest Diversity Action Plan guidance. 

Informing Diversity Goals for Clinical Trials

ACT: What should trial sponsors consider in working to define and inform diversity goals for trials?

In this latest version of diversity plan guidance, or the Diversity Action Plan Guidance, the FDA has put goals front and center. They've emphasized goals and then how you're going to get there, and that's really important from the standpoint of that's what they need to know and they need to hear and it's important from an operational standpoint, because if you don't know where you're going with your trial and what you're aiming towards, you certainly can't get there. That said, I think sponsors really need to understand, and we all, as advocates for diversity and inclusion need to remember that it's not just a number. The goal is to better understand your population before you start the trial. That population assessment is so key, and it's one of those things that we found in doing diversity plans is true.

As someone who's done policy on this topic for years, we understand that the intent of this is not just to meet that number, it's to truly understand what the differences are. Is there a difference in effect? To start that off, you need to make sure you do that population assessment and one of the things is in that we found, is that thorough that assessment to truly understand what your population looks like, what differences are in the care journey that a different race or ethnicity may face, a difference in how they present, differences in outcomes. Those things are so critical to informing that goal setting because your goal-setting has to be in context of the population for your trial. It has to not just be, let's say, breast cancer at large. It needs to be that specific type of breast cancer and specific place in the treatment.

Again, the population assessment, what we've found is, not only is it where you can turn your goals into meaningful, yet achievable goals so you understand what that population looks like, but it's also where you uncover some of what I often call the true gold in this. If a population tends to present differently in one condition or another, that's an important nugget from the population assessment. It may not affect your goals, but it will affect your operational plans, and then it also affects your ability to be successful. For example, we've seen populations where perhaps—let's take the Hispanic ethnicity as a group, first of all, we all know that's a simple proxy for a very diverse population—but digging into the literature and understanding, we start to learn things that you may not have seen if you weren't looking for it. For instance, some Hispanic populations, depending on their country of origin, didn't have a high prevalence of disease, but the disease particularly affected the Mexican American population. That is what I call gold that is helpful for planning, for site selection, for informing investigators, maybe even informs how you do your recruitment materials, and informs perhaps your commercial strategy. These are things that prior to doing diversity guidance, we weren't looking at. You assume all people react the same, and you proceed with that in a clinical trial, but diversity planning and doing a population assessment up front is yielding some useful insights, not just for better goal setting, but for better planning and better commercial success.

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