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1rem

Liz Beatty, co-founder and chief strategy officer, Inato, discusses:

The role of technology in improving site/sponsor relationships

How increased operational costs are impacting the industry

Podcasts

In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more. 

Improving Relationships and Diversifying the Site Selection Process

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

Industry’s greatest challenges in reaching diverse patient populations

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

Advancing more inclusive and representative clinical trials through action and accountability.

The Mandate Myth: What Actually Moves the Needle on Inclusive Research

Improving access while maintaining a high level of research.

Advancing Patient Engagement in Community-Based Oncology Research

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 

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), highlights the importance of equipping site staff and caregivers with tools and best practices to effectively communicate clinical trial opportunities to patients and improve enrollment rates.

Empowering Clinicians to Communicate Clinical Trial Opportunities Effectively

, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current state and challenges of cancer patient participation in clinical trials. Barriers to participation can include lack of understanding, economic burdens, and implicit biases. Robinson highlighted solutions such as increased education, legislation like the Clinical Trials Modernization Act, and engaging patients early in trial design. He also touched on the use of technology, such as biomarker testing and wearable devices, which can also enhance recruitment and reduce burdens.

ACT: Can you discuss the importance of training and supporting site staff to effectively communicate trial opportunities to patients?

Absolutely, I think there's lots of opportunities to educate both caregivers and patients. I think the data would support the idea that about 50%, maybe even three quarters of patients would participate if asked, but only 20% of them are being asked. So, how do we bring that number up and get more people involved? One way is certainly to develop best practices procedures, to better equip or educate our caregivers, is one way. An example of how that how the NCCN is working to do that is through the Health Equity Report Card. It's a tool designed to provide best practices for those caregivers, and one of the outcome measures is a tool that includes or encourages providers to have clinical trial conversations with their patients. At the most recent annual conference held by NCCN last March, they had a best practices session where clinicians, advanced practitioners, etc. could go and learn about how to engage patients, understanding that important details need to be delivered by knowledgeable staff, how to do it in a comfortable environment, using patients native languages, etc., providing take home materials that are in plain language so that a patient can actually go and digest it after having gone home from the hospital. Also, videos from other patients who have participated in clinical trials, to get that patient perspective is also an important way that you can educate.

Patients should also be able to understand the purpose and the risks of the studies. I work in the Oncology Research Program at NCCN, and one of one of my jobs is to oversee the IRB director's form there, and the IRB is a governing body at institutions that makes sure that clinical trials are held to the most rigorous ethical standards, and that group has put together a plain language database that can be used by clinicians and others to develop the informed consent documents, those documents that help explain to patients what's going to happen, what their data are going to be used for, etc., so plain language is a key point, and similarly, the NCCN Foundation has developed patient oriented guidelines that explain disease and treatment approaches, again, in plain language for those patients. Lots of opportunities.

Videos

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), shares insights on the complex barriers limiting cancer patient participation in clinical trials and explores potential strategies for improving access and diversity.

Understanding the Challenges Preventing Cancer Patients from Joining Trials

ACT: What are the primary barriers that prevent cancer patients from enrolling in clinical trials, and how can stakeholders address these challenges?

I think, like any complex problem, it's multifactorial. There are patient associated factors, through a lack of understanding of what clinical trials are, what it means to participate in clinical trials, can certainly decrease participation. It can even result in lack of trust in the medical system itself. Also, inability to find trials. Trials, by their nature, are complex, and as we've developed more advanced types of therapies, ones targeting specific mechanisms or pathways that drive cancer, we're looking to enroll subsets of subsets of patients, not an all-comers sort of scenario. So, understanding what trials I would be eligible for if I were a patient is more difficult.

There's also provider associated barriers. Data supports the fact that African Americans are underrepresented in our clinical trials, and there can be multiple reasons for that as well, but those can be exacerbated by the preconceived notions. Clinicians say, well, African Americans don't participate in trial, so we even see that they aren't even offered the option of, so there's a sort of an implicit bias going in that can limit participation.

Then finally, there's economic issues. There's an undue economic burden that can be placed on patients, and that can be both time as well as monetary. When you think about the way trials are run today, they're often centralized, require patients to come back multiple times for visits or lab works, imaging, etc. That can take a toll on what patients have to do, days off of work, childcare, just the cost of lodging at the sites, and the hours it might take them to drive to where the trial is being held.

Just like there's a multifactorial reason for the for the barriers, I think there's multiple ways that you can address it—education. The NCCN, as an example, provides webinars and informational materials designed specifically for patients, to educate them, not only on their disease, but also on understanding the purposes of trials. There's legislation that is currently looking to be enacted, an example of which is the Clinical Trials Modernization Act, which the NCCN, as well as a number of many other patient advocacy groups support. It's designed to reduce economic burdens for those patients that we just discussed.

Then finally, the pharmaceutical industry recognizes, I think, is beginning to put an even bigger emphasis on the importance of the patient voice in trial design, so engaging those patients earlier, the patient advocacy groups, early in the trial design to really understand, what are they going to be willing to put up with in a trial? What are the important outcome measures for them as compared to something else? Lots of ways to address the question or the problems.

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discusses the persistent challenges of low cancer patient enrollment in clinical trials and why broader participation is critical for advancing oncology research.

The Urgent Need to Boost Cancer Patient Enrollment in Clinical Trials

ACT: Could you elaborate on the current state of cancer patient participation in clinical trials and why it's a pressing issue for the clinical research industry?

I just want to also start by saying thank you for the opportunity to discuss this really important topic. When you think about the current state of clinical trials, historically, if you go into the literature, it's been thought that participation has been very low, less than 5% of the patients actually participate in clinical trials, but a recent 

, where they looked at data from a five year period spanning 2013 through 2017, suggests slightly higher, albeit not that much higher levels. For therapeutic trials, about 7% of patients overall participated, but it depends on the setting that you're in, so patients in an NCI-Designated Comprehensive Cancer Center, slightly over 20% of those patients participated, but when you're in the community, only 4% of patients participate, and that's for therapeutic trials. There's also different types of trials that maybe you don't necessarily think of initially. For those things like diagnostic trials or quality of life studies, 2.5-3% of patients participate, and where we're seeing reasonable participation, in my mind, are for biosample repository studies, where patients are willing to donate their tissues for future research, and there almost a third of the patients will actually donate their tissues. I think there's room for improvement, particularly when you realize that the types of advances that we have seen in cancer care over the last decade or so, they stem from data that were generated in clinical trials, so having as many patients participate with as diverse patient population as possible is really important. As a side note, NCCN, the organization that I belong to, supports that idea. All the guidelines that they develop have a box on the front, stressing the importance of clinical trials where appropriate and applicable for an individual patient.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, highlights how artificial intelligence can be used to address logistical barriers such as access and treatment cost.

The Role of AI in Solving Clinical Trial Diversity and Access Challenges

, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial intelligence (AI) in clinical trials, highlighting its potential to reduce costs, accelerate timelines, and improve inclusion. Looking forward, advancements with AI are expected to speed up drug discovery, predict drug efficacy, and develop digital twins for personalized treatment simulations, potentially reducing trial risks and costs.

ACT: How can AI be used to address underrepresentation in trials?

I think in general, access to clinical trials is a big deal, especially for people from underrepresented communities, and we believe that artificial intelligence plays a big role in changing that. Right now, the way to clinical trials and the way clinical trials are set up, often creates barriers that are very tough to overcome. Many trial sites are concentrated in big cities or academic medical centers, so if you live in a rural or underserved area, just getting to a trial might be out of reach, and for some people, there are also a lot of financial challenges like treatment costs or logistical challenges like transportation, and these burdens hit underrepresented populations especially hard, as well as people with lower incomes. Also, these people in those areas are not always made aware of the opportunities, not educated on the concept of clinical trials, and physicians are also not equipped to look for trials for their patients, so this leads to a situation, for example, in the US, where I think racial and ethnic minorities represent only 2% of participants in clinical trials, and that's of course a problem, because when certain groups are left out, we also miss out on crucial data, including how different people from different backgrounds respond to medications, so how can AI help? At myTomorrows, we lower the barriers for physicians and patients to identify and access trials. At the moment, we have two examples built into our product, where AI is used for treatment matching, where we save about 90% of the time that a physician is spending on matching a patient's profile to all those eligibility criteria. Second is education. As you know, the healthcare space is full of terminology which is very difficult to understand for patients and when it comes to clinical trials, it's even more complex, so AI can really help to translate consent forms, educational materials, etc. into multiple languages and use simpler terms, make it more accessible to non-English speakers and those also with low health literacy.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, discusses how these cuts are impacting critical areas of clinical research such as staffing and patient access.

Medical Research Funding Cuts: A Disruption in the Clinical Research Enterprise

, Michael Liu, medical student and researcher at Harvard Medical School, discussed a recent 

 on National Institutes of Health (NIH) grant cuts. Among other notable findings, the study highlighted that 20% of terminated grants were early career training grants, which are crucial for maintaining biomedical research pipelines. Liu also highlighted how the cuts have disproportionately affected institutions nationwide and compromised ongoing clinical trials, particularly those involving marginalized populations.

ACT: How have the NIH funding cuts affected the clinical research industry specifically?

Unfortunately, we didn't do an analysis of clinical research specifically, but it's not unreasonable to think that these cuts will have really impacted people in the clinical research industry, especially those who conduct trials. We know that trials are very expensive, and a loss of funding really compromises the ability to sustain and continue trials. I think what one thing that's really striking to us, I think I should’ve mentioned, was that a lot of grants that we saw were being cut were kind of cut halfway. There weren't grants that were just at the beginning or middle or the end. These could be trials that are in the middle of recruitment or in the data analytic period, and that's, I think, really deeply influential. They compromise our ability, whether you're delivering a drug or intervention, and not being able to afford continuing that or providing that to participants, if you're not able to employ staffs, research coordinators, research assistants, and to be able to keep the lights on in the building or lab, it's deeply disruptive.

I think the other thing that I would emphasize is that most times, clinical research, probably all the time, is that you're working with patients and patients place a lot of trust in us to be able to participate in trials and receive interventions. Particularly, we know that the NIMHD (National Institute on Minority Health and Health Disparities) was disproportionately affected, and these are interventions that tend to affect more marginalized disadvantaged populations and who already have rightfully so, distrust of healthcare systems and a lot of the research that we do. I think these cuts further potentially compromise the relationships and trust that we have with patients to continue to sustain the clinical trial enterprise.

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.

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. 

DEI

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