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Twice-yearly lenacapavir, a long-acting HIV-1 capsid inhibitor, reduced HIV infections by 96% in the Phase III PURPOSE 2 trial while showing superior efficacy over daily Truvada.

New Phase III Data Show Twice-Yearly Lenacapavir Reduces HIV Infections by 96% in Gender-Diverse Populations, Cisgender Men

Findings from two Baltimore medical centers presented at the American Society for Radiation Oncology Annual Meeting suggest spiritual themes and distrust may be behind the decline in trial participation.

New Survey Uncovers Distrust as Key Factor in Enrollment Declines Among Black Patients

Cohort study of over 290,000 patients found disparities in cancer stage at diagnosis and survival.

Racial Disparities in Late-Stage Cancer Diagnosis for Adolescents and Young Adults

Despite the substantial advertising dollars spent annually, patient recruitment remains one of the most difficult challenges that clinical research professionals encounter. 

Trends in Patient Recruitment Advertising From 2012-2019

Panel discusses the advantages that these models can provide in adding efficiencies to the clinical trial process. 

DPHARM 2024: The Benefit to Adapting Operating Models

In an interview with Nico Saraceno at DPHARM 2024, Pellegrino highlights current challenges she is seeing in patient recruitment and the use of technology to identify patients. 

DPHARM2024: AutoCruitment CEO Jill Pellegrino Discusses Patient Recruitment

ACT: You hosted a session on how to “Unlock the Power of the Patient for Better Patient Recruitment Outcomes.” What was the premise of the presentation?

 It was talking about a company, AutoCruitment, which focuses on bringing patient recruitment solutions. There's really two primary points I was trying to make in that. One is that to really substantially change the way that clinical trials are enrolled, and to increase the patient number of people that get access to trials, you really have to develop solutions that focus on a very large part of the population that doesn't get the opportunity to participate in trials when you're working through sites alone. We find that only 10% of the patients that are eligible for trials actually get the opportunity to participate in one with the relationships they have with sites. Our recruitment focuses on that other 90% in developing strategies to access that population. That was the first primary point, but the second point is that you have to have in place the right services to qualify those patients to help support the sites and the patients to make sure that they are translating into randomized patients. We talked a lot about the services and the ways that we accomplish that.

ACT: In your experience, what are the most common patient recruitment challenges that you’ve encountered?

 Access to patients is absolutely one of them, but even when you get access to those patients, qualifying them is really, really critical, because the protocols usually have very narrow inclusion/exclusion criteria. A lot of times that inclusion/exclusion criteria can't be validated unless you have a relationship with that patient or have access to their medical history, so depending on the requirements and the complexity of the protocol, sometimes it can be difficult to find patients that are qualified and appropriate for the clinical trial. That's one of the challenges. The other challenge is that you do rely on the clinical trial sites to make a recruitment campaign successful and clinical trial sites are working on a lot of trials right now, and sometimes they're understaffed and they don't have all the resources they need, so you need to be able to have support for those sites to be able to work with the additional patients so that they can capture more patients in their practice, see those patients, and then put them into trials.

ACT: Could you describe what EMR Capture & Intelligence technology is exactly, and how it can help identify and qualify patients?

 Yes, that was EMR Capture & Intelligence, and that's one of the services that we have to help better qualify patients for complex protocols. Patient recruitment companies a lot of the time rely on self-reported data from patients in order to see if they're eligible to refer them to trial sites, so we're not relying purely on self-reported data. We have a new service, EMR Capture & Intelligence, which allows us to get the consent from the patients directly to review their medical records. It's all automated in our technology, where we can collect their medical records very easily for them, and then we have AI-powered technology that reviews those records and organizes that data and assesses it to see if they're eligible for the protocols. We find that is really effective in some of those harder conditions and more complex protocols to be able to find some of those harder to find patients.

ACT: What other sessions or topics at DPharm have piqued your interest?

 I would say an area that's always top of mind and top of interest for me is different strategies to be able to access patients, as I shared. We find that to be really effective in driving higher enrollment rates, you have to be able to reach that 90% of the population, so I find I'm really pleased to see so many companies that are working in this space now looking for creative solutions and ways to find patients, and that's always an area of great interest to me and AutoCruitment.

Videos

Latest Conference Coverage

Smith discusses how predictive modeling and community engagement can increase diversity.

DPHARM 2024: Acclinate CEO Del Smith Highlights the Roles of Technology and Engagement in Clinical Research

ACT: You have an upcoming session on “Harnessing AI/ML to Drive Sustained Community Engagement for Diverse Clinical Trial Participation.” What will be the premise of the presentation?

 Yeah, so I'll be talking about the use of AI/ML (artificial intelligence/machine learning) and sustained community engagement to help drive clinical trial participation. Really, what we're doing is we know that AI/ML is one of the hottest topics of today—this new technology that's there—and we're really leaning into this idea of coupling that technology with one of the most traditional ways that we know of having active participation from communities, and that is sustained community engagement, getting into the communities. What I will talk about is how you marry those two things together so that you have the sustained engagement that creates trust, data, and how you can take that trust in data and utilize predictive analytics and AI to help make very precise decisions about who's most likely willing and able to take part in clinical research.

ACT: What is needed to design and develop a predictive model that produces the highest potential for engagement?

 It's really important when you're developing this AI/ML model for clinical trial participation to take a combination of social determinants of health data along with what we call engagement data. An example that would be SDOH data may be, simply, what is the zip code of the person that you are engaging with, and the engagement data would be something along the lines of how often or how engaged is that individual when it comes to trying to get them active in making decisions about their health. When you combine these two sources of data together, and you take it through your proper algorithms, you can get some pretty high confidence in terms of who's willing and able to take part in that particular research study.

ACT: What do you believe is needed in order to better connect with communities of color, while increasing overall diversity in clinical research?

 We talk a lot about this combination of sustained engagement and technology, but I really want to emphasize that it really starts with the engagement. There's no amount of technology that's going to be created or developed that's going to instantly increase a person's level of trust in the clinical research or instantly increase their level of education or awareness or empowerment about clinical research, and that a lot of times happens on the ground. It's really, really important that whatever solution that we look at to try to increase diversity in clinical trial participation starts with and leans very heavily into some type of actual engagement with either the community or what some people call the patient themselves, but it can't just stop at that alone, because we’ve got to have something that's more scalable. We have to have something that's more predictable. We have to have something that allows us to tie to specific outcomes as it relates to being able to mobilize those people for clinical trials, and that's when the combination of sustained engagement and technology must come together.

ACT: Keeping all of this in mind, what inspired you to start Acclinate, and what challenges did you face in the midst of the pandemic?

 Yeah, the seed for Acclinate was planted many, many decades ago. When I was a teen, my mom was a healthcare professional. Unfortunately, she contracted tuberculosis during home healthcare, and after about a year, she passed away unfortunately, and I discovered about three months later, there was a clinical trial going on in the area that we never knew about. I did not realize at the time how significant that experience was going to be for me, but over time and the experiences, I got to a point where I recognize that there's really only one way to keep that from being systematic and happening, and that is to do this sustained engagement work, building trust in communities, making sure that they're aware and knowledgeable about clinical trial opportunities so they can make a decision to be part of clinical research.

In an interview with Nico Saraceno at DPHARM 2024, Smith discusses how predictive modeling and community engagement can increase diversity.

Jim Murphy, CEO of Greenphire addresses the increasing complexity of trial protocols and how it is affecting patient access.

Working Towards Greater Access and Diversity in Trials

What are some trends that you're currently seeing with patient reimbursement?

 There are a huge number of trends that are happening now. I think the first one is just that there's a recognition that patient burden is going up because protocols are getting more complicated, meaning narrower inclusion criteria, longer and more frequent visits and whatnot. As burden goes up, it's harder for people to commit to going into trials, and it's harder for them to stay in those trials once they join and with that understanding and combining that with the notion of trying to create greater access and diversity in clinical trials worldwide be really good science and good social policy as well. There's a movement to change and make sure that the demographics of clinical research are not middle-class males, which is basically what a disproportionate number or proportion of the population in most studies has been till now, so that notion of patient-neutral spend, making sure that a participant that does want to participate in a trial is not going to incur costs. That is a really big movement, and that's the biggest trend. Behind that is a little bit of a drill-down into recognition that if you're a childbearing age adult, your needs, predispositions, and support requirements are going to be very different from somebody who is retired, octogenarian, so knowing that, there's not going to be as much of a childcare or a pet care, or maybe there's instead a companion support element. Those are all really important things to understand about your therapeutic area and your target demographic. Also, certain concentrations of people, they vary across geographies, not just big city, small city, but in different countries where it's just laid out differently in the health system. There's a lot of recognition of variance, which is a huge thing.

In part 3 of this video interview, Jim Murphy, CEO of Greenphire addresses the increasing complexity of trial protocols and how it is affecting patient access.

Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara sheds light on industry collaboration and what elements of trial design have the greatest impact on diversity.

The Role of Collaboration in Achieving Greater Diversity in Clinical Research

ACT: What areas of trial design should stakeholders be focusing on the most to increase diversity within their studies?

 Once we account for access, education, and awareness and I think once we've got patients in our clinics and we want them to have an equitable experience, I think one of the things we have to look at, for starters, is our inclusion eligibility, and that the ways in which we may unintentionally be excluding patients before they've even gotten through that first screening visit. I know the idea that all women of childbearing potential have to take a pregnancy test. Well, for some women of childbearing potential, that should be optional considering lifestyle, gender identity, and sexual orientation when you're thinking about more disease state-specific things, and this idea of certain patients are more prone to and have a higher risk in certain comorbidities. If you're looking at kidney disease, for example, when you're going to set a requirement—inclusion or exclusion requirement around chronic kidney disease—you have to consider that different portions of our population suffer from kidney disease in different ways. There is more prevalence among certain communities, which leads to higher and varying EGFRs, certain kidney disease markers, and traits that don't exist potentially in other communities or are significantly lower in other communities. Those are things we have to consider when we're writing inclusion criteria and thinking about when you're writing these things, who may we be unintentionally excluding and we're not even meaning to? How can we make sure that everyone we want to have an opportunity to participate here is able to, from the get-go, when reviewing those inclusion/exclusion criteria.

ACT: How important is industry collaboration when it comes to achieving greater diversity in clinical research?

 I think it's a must. I don't think we can do it if we can't do it together. On the site side of things, I've got patients in the room, and I'm ready, and I'm noticing things are not really panning out the way we plan them, because the best laid plans on paper—you put them in a clinic, you think you know if something's going to happen, it's going to happen inside of a clinic, but to be able to share those best practices back to our sponsors and CRO partners, but then also some of our tech vendors to say, “Hey, I know you meant for this to be easily accessible to all patients, but this demographic of my patients is really struggling. Can we consider doing something a little bit different with the technology? This particular assessment—if you thought it was going to take 20 minutes, is actually taking about two hours. How can we refine this process, still getting the necessary information, but to do a bit more so in a way that's more conducive to the patient experience?” We can only do that if we all are willing to sit at the table and have the conversation around the patient experience and making sure our patients have that that, what we call, white glove service, and making sure that they want to come back and they want to participate, but we all have to be willing to sit at the table, so to speak, to have that conversation around what we can do better, to collaborate.

In the third and final part of this conversation, Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara sheds light on industry collaboration and what elements of trial design have the greatest impact on diversity.

Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses the guidance and how it will affect sponsors moving forward.

Ashley Moultrie of Javara Shares Thoughts on FDA’s Diversity Action Plan Guidance

ACT: What are your thoughts on the FDA’s recently released Diversity Action Plan Guidance? How will this affect sponsors moving forward?

 I am a strong proponent for what gets measured gets done, so I strongly believe having the industry guidance—once finalized and put into action—it'll require a level of accountability that I think a lot of folks may have been working towards or figuring out, but having that requirement makes it real. I think it sets a precedent for what has to happen, and I think folks will start moving more intently towards those goals. It's when somethings are nice to have versus when it's a must have—I think we move differently, we allocate resources differently, we discuss planning, and things like that a bit differently when things are required. That requirement piece, I think, is necessary, and we've seen the shift already with just the guidance coming—the ways in which things are changing. Once the guidance of finalized and it's moved out, I think that that change and that shift is going to happen much more robustly.

I think for our sponsor partners, one of the biggest things to consider is how it's going to affect implementation. We may have to adjust how we handle timelines and how we set these goals, there may likely be more time spent up front and figuring out of how to disseminate and when we're going to do trial selection, where are we going to place these trials, who are the investigators are going to look at? But again, that level of accountability, I think, is going to force a lot of us, and not just sponsors and CROs, at the site side as well, to do things a bit differently and consider things a bit differently and prepare differently so that we can meet those goals.

In part 2 of this conversation, Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses the guidance and how it will affect sponsors moving forward.

Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara highlights how IROs are bringing care directly to patients and making them feel more comfortable.

Increasing Diversity with the Integrated Research Model

ACT: What do you think are currently industry's greatest obstacles in achieving more diversity in trials?

 I would say, one, being access. I think we have lots and lots of opportunities across our industry, but they're concentrated in pretty specific areas, and have been for a while. I think if we can solve the access problem, we would be doing a great service. I think one of the other things that once we—if and when we—get past the access problem, it's this idea of what I consider clinical trial education and awareness. We can have all the trials in all of the places, but if folks don't really understand the process—I'm a big proponent for informed consent can't start a screening visit. We have trials in all of the places. How are we making sure folks understand what they're really signing up for and what they're volunteering to do? I think one of the biggest ways we can combat that is through community engagement, education, awareness, and making sure once we've solved for access and we've got plenty of opportunities in lots of places, we also have folks who are ready to make informed decisions. So, making sure that we are out and engaging in communities and with potential patients and families of potential patients significantly early in the process and not waiting until we have a trial to start having those engagement conversations.

ACT: Can you explain the model of integrated research organizations (IROs)? How can they help increase diversity in trials?

 The idea of the IRO is making sure that folks can get access to clinical trial opportunities where they're already receiving care. An IRO, like Javara—our entire goal is to essentially be the research infrastructure for a practicing physician, and in that way, our teams fully integrate within the practice or hospital setting—wherever the physician may be. We integrate into systems, so we become a part of the physician’s care team. I joke a lot when I worked in the clinic that sometimes folks didn't know if I was a Javara person, or if I worked Dr. ‘so and so.’ We do that very intentionally because we want folks to feel like we're an extension of their care, and not this, mystery piece and mystery folks who are just coming in to do this thing. I think our integration in that way, it sustains our longevity within the practices and institutions where we partner, and it gives potential patients and existing patients an opportunity to see it like that—we're committed, we're seeing this entire thing through. I think that's the biggest differentiator. People can get care where they're already going. They can get clinical trials where they're already receiving care, and they get that continuum of care with their care teams. We're an extension of that team.

I've had patients in my career—one of my favorites is that my patient said that they were only going to do it if they can see their usual phlebotomist, because they've been going to that practice for 20 years, and that's the one person who can do it right, and get it done quickly. Being integrated in that way allows us to give patients that flexibility. We make sure the entire care team is on board and they're aware of what's happening. Now, everyone can't do all of the things, but there's a level of familiarity there that I think makes patients much more comfortable in participating. One of the hurdles that I didn't mention earlier, as far as participation in clinical trials for marginalized communities is that there's a level of distrust with the health system as a whole, not necessarily just clinical research, but if I get to have my usual physician provide insights and suggest opportunities, for me, I am much more likely to trust them versus someone who I've never seen before—cold calls, and while I do understand in some places, cold call works, but when we're already fighting an uphill battle of improving and trying to turn the tide of our industry, it sort of missteps. Having that trusted partner, I think, is key in helping move some of that forward, because patients are there, relying on those physicians and those health professionals to give them guidance on all of their care, so why would a clinical trial be any different? I think that's something that we really hone in on with our investigators.

In part 1 of this video interview, Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara highlights how IROs are bringing care directly to patients and making them feel more comfortable.

Del Smith, PhD, co-founder & CEO of Acclinate highlights challenges sponsors may face in light of FDA releasing its Diversity Action Plan guidance.

What Sponsors Can Expect From FDA's Diversity Action Plan Guidance

ACT: Does the FDA’s Diversity Action Plan guidance create any additional challenges for sponsors? How can they be addressed?

 Well, I think the guidance can create some additional challenges for sponsors, not because of the fact that there's ambiguity or that what's being asked is unreasonable. I think it will create challenges because it's essentially saying to sponsors, there's no silver bullet for achieving clinical trial diversity. If you look at the specific language around community engagement, for example, I think that's the FDA recognizing that trust is a major issue contributing to this problem, and really the only way to address the issue of trust is to figure out a way to connect and be involved in the communities to overcome that trust. I think that part is what sponsors are going to probably have the greatest challenge with. That's not a core competency or core strength of theirs, but I also think there's opportunities for them to partner with organizations and companies that have that as a strength, particularly when it comes to community engagement to overcome those specific challenges.

ACT: In addition to this guidance increasing diversity awareness in clinical trials, what else do you think industry can work on to increase awareness?

 I think there's two elements of this guidance that some people were hoping for or expecting, and that had to do with laying out specific goals for diversity, and the other one had to do with what are the repercussions or ramifications if diversity is not met on a particular study? Neither one of those two are in the guidance, and I actually think that's a good thing. I think it allows the industry to have an opportunity to really learn from best practices and what really works, and to develop those strategies internally and for themselves. I would like to see, in future iterations of this, getting to the point where we have enough data from what sponsors are actually achieving with diversity action plans to start to infuse some goals there that people can hold themselves accountable to do.

Smith shares his initial thoughts on the guidance and what its impact will be on the industry moving forward. 

Acclinate CEO Del Smith Discusses FDA's Recently Released Diversity Action Plan Guidance

ACT: What are your initial thoughts on FDA releasing the Diversity Action Plan guidance?

 My initial thoughts on the FDA releasing their guidance on clinical trial diversity is all positive. I know we've been waiting for this for quite some time. It was delayed. There was a lot of discussion about what would be in it, how would it change from the previous draft guidance, and I think that the FDA has done a really great job with providing greater specificity on some of the details that's being requested from sponsors. I also think at the same time, they're leaving a lot of opportunities for sponsors to determine how they best see trying to achieve greater diversity in their trials. So overall, I'm excited to see the guidance and excited to see the continued discussion and focus on clinical trial diversity.

ACT: What will its impact be on the industry?

 I think what you're going to see from sponsors after this most recent guidance is the majority of them will take very progressive and positive steps to try to achieve what the FDA is outlining in the guidance. I think you'll also see some separation. You'll see some sponsors that are saying, “Listen, we're going to invest even more, and we're going to dig deep and go even beyond what is being asked of us in the Diversity Action Plan.” You're going to see some sponsors that are going to, frankly, try to just meet the bare minimum when it comes to what's being requested. Ultimately, what we're going to find is that those sponsors that are making the investment to make sure they have adequate representation in their trials, in their data—so that we know that the drugs have the same level of efficacy and don't have negative side effects, simply based upon a certain subgroup—are going to win overall. You'll see more sponsors putting focus on this, but you'll also, I think, see some sponsors that are becoming market leaders in this particular space.

Pamela Tenaerts, Luke Gelinas, and Pam Diamond highlight the potential impact FDA's Diversity Action Plan guidance will have on industry. 

Industry Leaders Discuss the Impact of FDA's Diversity Action Plan

 I think it'll help the industry get more data, actionable data on a diverse population—there's different ways to do that. You can change your inclusion/exclusion criteria. You definitely work with the communities. It's also becoming clear that decentralization could be part of the how you get there. You have to have your goals reflect the population and then you have to have the rationale of why you picked those percentages or those things, and then one of the things that's emerging is that decentralization could be one of those things. We had some recent data come out from the PACT (Partnership for Advancing Clinical Trials) consortium that showed that using decentralized elements, there's an emerging trend of more diversity, with less white people enrolled and more Asian people enrolled, so I think we want to get more data on that, but it's important that the industry is moving in that direction, and that we're all doing the right thing.

 It's going to force industry sponsors to think really carefully about the types of patients they're trying to reach with their drugs, about what they think representative clinical trial sample looks like. I think it's going to force us a lot more critically and deeper than we had before about what diversity means and what aspects of it are important in terms of sex, ethnicity, race, gender—those are the ones that FDA guidance is focused on. I think it's going to be positive in the sense that it's going to force the industry to step back and say—for each different drug that are assessing or device—what is the patient population that we're hoping to reach with this drug or device look like in the real world? That’s really what we should be using to draft our diversity plans for clinical trials. We should be trying to capture the patient groups in terms of demographics that you're actually going to serve with the product, the people who are going to take the drug or device, should it become available on the market. It will be good in that respect, and helping industry to think hard about those things. Again, I think it's always good to have a plan. This is the first step in actually increasing diversity, but I think there's more work to do beyond the plan, but again, good first step.

 I could see a short-term consequence, that early on, it might actually increase the expense that sponsors will have in conducting clinical trials. It will be more expensive to recruit a more diverse participant population, and to retain those participants, but I'm very hopeful that in the long run, sponsors will be able to save both time and money—financial resources—in the long run, because we’ve all seen trials that were not very representative, and a lot of money and time were spent on that trial, and it turned out that—say if it was a drug that was under testing—the drug wasn't really effective in populations that weren't part of the clinical trial. I've seen numbers like one and a half billion, or even in excess of one and a half billion, to bring a drug to market, so if you spend all that money and then when it goes to market, it really isn't helping the patients that have that condition and that need that medication, it's a lot of time and money wasted. Again, I see short run, we might have to spend a little bit more money, but in the long run, I think we're going to see more efficiency and savings. The other thing I could see happening if we're all really good at following the FDA guidelines is that more trial activities will be done virtually in order to enroll and retain more diverse participants. We just have so many individuals that don't live close to academic research sites, or even physical clinical research sites, and it would be really good if we could bring more of those participants into clinical trials. Hopefully, and it's something that our company, Curavit focuses on, is doing as much of the trial virtually as possible, so that we can engage diverse participants and keep them engaged throughout their trial.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit highlight the potential impact FDA's Diversity Action Plan guidance will have on industry. 

Pamela Tenaerts, Luke Gelinas, and Pam Diamond share their initial thoughts on the announcement of FDA's Diversity Action Plan guidance.

Industry Leaders React to FDA's Newly Announced Diversity Action Plan Guidance

 It was awaited, so we're all happy it came out and I think it's going in the right direction. I think they lay out a logical plan for why this is important and how this should be done, and what you could potentially do to achieve diversity. To bring it back to why this is important, we need to have trials that reflect the intended population. I heard a story yesterday about an oncology patient who's African American—the mother of somebody in our industry, and they were looking at a particular drug, and they had no information about her—African Americans, and that is not right. This highlights the importance of this, and I think sponsors in our industry are wanting to do the right thing, and this helps us get there.

 I think it's a step in the right direction. I think the whole clinical trial industry and ecosystem is in agreement that enhancing diversity of clinical trial samples is urgently needed. To get anywhere in life, it's good to have a plan, right? I think it's important to note that these are diversity action plans, so it's always good to have a plan. There are a couple of limitations. One is that, for me, the big question is, is FDA going to find a way to enforce these and to hold sponsors’ feet to the fire, not only in terms of submitting the plans to them, but actually meeting the plans. Are there going to be mechanisms to check in and say,” Hey, you didn't actually meet the plan that you proposed.” Is there going to be any way for us to measure that and then to put a little bit of pressure on people or sponsors who don't? But I think it's good. I think it's a step in the right direction. Again, it's only for Phase III and other pivotal trials, so it doesn't cover all studies, but it covers the big ones, so I think it's good.

 I do have some initial thoughts. One thing that I think is really good is it's really for better or for worse, forcing us all to think more about what does diversity in clinical trials mean? I think in recent years, we've paid a lot of attention to trying to diversify trials in terms of race, ethnicity, age of participants, sex of participants, but I noticed the guidance is really emphasizing what are very valid considerations to continue to pay attention to what I just mentioned, but also pay close attention to geographical location—does someone live in an urban or a rural location? That constitutes diversity in trials. We also need to pay attention to differences in socioeconomic status or income status, need to pay more attention to disabilities, sexual orientation, gender identity of our participants, so I think the FDA draft guidance has been a good reminder for all of us in the industry that we need to pay attention to things other than race, ethnicity, age, and sex of participants. There are a lot of other important factors that we need to pay attention to increase inclusivity in clinical trials. I also think that I'm hoping that these guidelines will lead to greater trust across the industry, whether it's increased trust between sponsors and regulatory organizations, but more importantly, in my mind, hoping it will increase trust between sponsors, CROs, and potential trial participants.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their initial thoughts on the announcement of FDA's Diversity Action Plan guidance.

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