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1rem

Sponsors and CROs that work with these sites can better reach marginalized communities.


Case for the Underdog: Unleashing the Potential for Small, Community-Based Research Sites

To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.

Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials 

The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.

FDA Finalizes Decentralized Clinical Trial Guidance

New paper features insights from nearly 100 experts on four key barriers to clinical trial access.

Abbott Publishes New Strategies to Improve DE&I in Clinical Research as Part of Diversity in Clinical Trials Initiative

How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach. 

Enhancing Empowerment in Patient-Focused Research 

Industry experts discuss the use of decentralized technologies and the potential of artificial intelligence in reaching underrepresented patient populations. 

Peer Exchange: Technology's Role in Achieving Greater DE&I in Clinical Trials

In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group highlighted a variety of topics including current challenges they are seeing, the use of technology, and more.

Moderated by Otis Johnson, PhD, MPA Co-Founder & Principal Consultant, Trial Equity, the panel featured key insights from Sophia McLeod, Sr. Director, Government Relations, ACRO; Erin Stern, PharmD, Research Support Pharmacist, Mayo Clinic; and Caitlin Brown, PharmD, Neurocritical Care and Emergency Medicine Clinical Pharmacist, Mayo Clinic.

Brown highlighted the progress in women's representation, but also noted challenges with racial and ethnic groups due to historical mistrust, access, eligibility criteria, and language barriers. McLeod emphasized the importance of early diversity planning in protocol design and community engagement. Stern discussed the logistical challenges of decentralized trials and the need for better technology integration. The panel agreed on the necessity of consistent funding, community involvement, and ethical artificial intelligence use to enhance DE&I in clinical research.

Videos

Participants touch on the different aspects of FDA's recent Diversity Action Plan guidance and how industry must be held accountable for implementing change. 

Peer Exchange: Accountability for Implementing Diversity Action Plans

In the second part of this roundtable discussion, participants highlight best practices for reaching underrepresented populations and increasing their awareness of clinical trials. 

Peer Exchange: The Importance of Improving DE&I in Clinical Trials (Episode 2)

Peer Exchange: Reaching Underrepresented Patient Populations

In the first part of this roundtable discussion, a panel of experts introduce themselves and highlight the challenges industry is seeing with underrepresentation of racial and ethnic groups in clinical trials.

Peer Exchange: The Importance of Improving DE&I in Clinical Trials (Episode 1)

Peer Exchange: The Importance of Improving DE&I in Clinical Trials

In this video interview, Jay Park, founder & scientific lead, Core Clinical Sciences, discusses how risk-based monitoring can alert sponsors of falling short of enrollment goals. 

The Role of Risk-Based Monitoring in Achieving Greater Diversity

, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent 

titled, “Diversity Action Plans in Clinical Trials.” In addition to key takeaways from the article, Park and Metcalfe discussed the FDA's new guidance for diversity action plans in clinical trials, the role of risk-based monitoring as a tool for improving diversity, and the importance of patient-reported outcomes.

A transcript of Park and Metcalfe’s conversation with ACT can be found below.

ACT: How can risk-based monitoring be adapted to support diversity initiatives?

 Risk-based monitoring or RBM really helps to ensure that we can conduct quality trials by monitoring and mitigating risks as they occur. With RBM, we often think of it as a way to monitor safety and data quality, but now with this mandate, the sponsor of each trial now faces the risk of falling short of these enrollment targets, and they may be required to conduct post-marketing surveillance studies. In reaction to diversity action plans, many trials are already using RBM to monitor enrollment targets over time, but one question we can ask ourselves is, “What happens when the trial is falling short of these enrollment targets? How do we respond to that?” With these patient-reported process metrics, we can better assess what the patient experiences during the clinical trial, when they are being approached for their enrollment, and how they're being managed during the follow-up visits. In trial sites located in regions with diverse populations, we can perhaps ask why the minority populations are not being enrolled into the study and why they may not be adequately retained in the study as well.

In this video interview, Rebecca Metcalfe, principal scientist, patient-centered research, Core Clinical Sciences, highlights the consequences of focusing solely on enrollment targets.

Addressing Limited Engagement With Underrepresented Communities in Clinical Research

ACT: While the FDA Diversity Action Plan guidance is a step forward, why do you feel that even with diversity quotas, trials may still have limited engagement with relevant underrepresented communities?

 That's a great question. As Jay and I mentioned earlier, really a major theme in our piece has been the need for system change and accountability for that change, and specifically measuring how clinical trials are done, and not just who participates in them. The goal of these recent initiatives by the FDA is twofold. On the one hand, they support the generation of evidence that better reflects the population of patients that may be eligible for a given treatment, so that's a scientific good. On the other hand, these initiatives support relationship and trust building with historically marginalized and excluded communities, many of which have been exploited by medical research in the past, and that's a good for the fabric of our society. Focusing just on the numbers by using enrollment targets will address the first goal, but not really address the second goal, so in this article, we advocate for process measurements that are designed in collaboration with relevant underrepresented communities to make sure that what matters to community members about how research is done is identified, and then through monitoring, we can make sure researchers are accountable for supporting inclusive processes throughout trials. A key component of this at the system-level is making sure that underrepresented communities don't just participate in clinical research, but they really lead clinical research. Studies suggest that when we have concordance between investigator and participant race and ethnicity, that improves the enrollment of ethnic and racial minorities. On the other hand, we also have studies showing that female and Black individuals are underrepresented among principal investigators, so among those folks that are leading research. In addition to improving the processes actually within a given trial, we also need to think more broadly about what perpetuates these systems that led to this exclusion in the first place, and then what changes are needed at that higher level to improve representation in clinical trials in a sustainable way.

In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, share their reactions to the FDA releasing its Diversity Action Plan Guidance.

Just the Beginning of Improving Diversity Initiatives in Clinical Trials

ACT: What was both of your initial reactions to FDA releasing the Diversity Action Plan guidance over the summer?

 Yeah, it's been really great to see the FDA, and specifically the Oncology Center for Excellence group taking the leadership on this much-needed initiative. I believe we certainly have a long ways to go, but I'm very optimistic that we'll continue to see improvements and making future studies be more representative, I'm grateful to be part of this dialog and contribute. In addition to our article that's been published in 

, we have submitted our recommendations to the FDA docket for this draft guidance as well.

 And just to add to what Jay said, I'm really appreciative that the FDA is using this iterative approach to develop the guidance. This is just the most recent draft with some substantial changes, but throughout this process, they've been integrating feedback from industry, community, patient organizations and academics, and we can really see the layers of feedback in building this latest draft guidance. I also agree with Jay that these changes are very much needed. We know that clinical trials have historically not represented the broader population, and in particular, have excluded non-white racial and ethnic communities. Given that historical context, it's really important that the work starts with those communities. We hope, though, that it's just the start, and that these changes have downstream benefits for other historically excluded and marginalized groups in the context of clinical trials, such as patients with disabilities or multiple comorbidities and individuals with diverse sexual orientations and gender identities. I also just want to make a nod to the broader impact that this guidance can have, which is really that the FDA is leading the way on improving representation in clinical trials and as a company that's based outside of the US, but does a lot of work in the US, it's exciting to see how these changes will likely ripple out into other regulatory bodies and health technology assessment agencies. This isn't just a great thing for people in the US, it's a great thing for clinical trials around the world.

In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, discuss a recent article they authored on the guidance.

A Strategic Look at FDA’s Diversity Action Plan Guidance

ACT: Could you tell our audience a bit about your article “Diversity Action Plans in Clinical Trials” and provide an overview of some of the key themes?

 I think there are a few key themes in our piece. I'm going to touch on the one that I think is the most salient, which is this broader question of how we measure improvement and ensure accountability, and that really includes what we measure and also when we measure it. Right now, the FDA guidance is suggesting that we should use enrollment targets tied to epidemiological evidence about who is impacted by a given condition. While that's important, we don't really believe that enrollment targets alone are sufficient to measure change, because underrepresentation of specific groups in clinical trials is not something that just happened. It's really the result of complex societal processes and systems, and what that means is that in order to make meaningful change, we need to address those systems, both broadly at a societal level and then also at the trial level by making sure that trial processes are inclusive and reflect the needs and priorities of patients and communities that have been historically excluded. The focus of our piece is really about shifting how we think about measuring change in representation in clinical trials and then grounding that shift in meaningful patient engagement.

 Building on what Rebecca has said, our article is really about adding to this important initiative that's being honed by the FDA, and it's been really nice to see such an important collaboration between the FDA, industry, and other patient organizations on these diversity action plans. While we believe that this the right step forward, we can learn from other diversity initiatives outside of the clinical trials landscape. We have seen in other areas where diversity quotas have been implemented, positive changes were only achieved when there were also accountability implemented as well. Our paper intends to provide actionable recommendations with the framework for risk-based monitoring that is commonly used in clinical trials. Already central to our recommendation is what we call patient-reported process metrics. The rationale these process metrics in how patients are engaged for enrollment and how they're retained during the follow up is similar to PROs or patient-reported outcomes as a supplement to the enrollment targets we can benefit from hearing and learning from the subjective experiences that patients are involved in during their clinical trial experience, and by listening to the patients and giving them a voice, we can be more patient-centric instead of just having enrollment targets. There will be some other benefits as well. In terms of managing risk, we can assess these process metrics during the trial at the same time, we're monitoring these enrollment targets. This couldn't be an important way to modify enrollment strategy. In the unfortunate case that the trial itself is running behind, it's in diversity enrollment targets, and after the trial, we can also use these process data generated to plan for post marketing, market surveillance studies, should they become necessary, or other future studies that diversity action plans will be mandated for.

In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses some key initiatives around decentralized capabilities and underrepresented patient populations.

Navigating Diversity and Digital Innovation at the Site-Level

, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key challenges and initiatives at the site-level. AI's impact on sites is significant, with uncertainty around its implementation. Diversity requirements pose challenges, and technology overload is a major issue due to inconsistent tech stacks and financial burdens on sites. Bechtel also highlighted some initiatives that SCRS is currently working on and gave an overview of the most recent Global Site Solutions Summit.

A transcript of Bechtel’s conversation with

ACT: What are some initiatives or projects SCRS is currently working on and what excites you most about them?

 The third one that I'd mentioned is the Digital Innovation Initiative. This has been a program that we've had in place since 2019, but it continues to provide innovation for sites. We produce a lot of really great things from that program, like a virtual-capable trials training, so a foundational training for sites looking to understand what it means to participate in trials where some of the elements are conducted virtually or decentralized.

We’re working now on what we're calling the Challenges and Solutions Charter. We know that there's a lot of challenges when it comes to conducting trials with decentralized elements. We spend a lot of time as an industry talking about those challenges and talking about the solutions, so what this initiative aims to do is put a pin in the specific challenges as well as the solutions associated with them, and then gain commitment from some of our partners to say, “Yes, I agree that that is the challenge and the solution to that challenge, so I'm going to commit to implementing that solution within my organization based on a timeline, a reasonable timeline that we're going to determine in this multi-stakeholder development process.” That's just one exciting new development that we're working on in that program.

Finally, the SCRS IncluDE initiative. This is our legacy diversity initiative. We are calling it the IncluDE initiative now, and they're doing some really, really great work as far as allowing sites to participate in a tool we've developed called the Diversity Site Assessment tool, or the DSAT tool. That's an assessment that sites can log onto our website and take and understand how they fare where they sit on the spectrum of their ability to recruit and retain diverse patient populations. We recently launched a sub-questionnaire related to that tool around seen and unseen disabilities, so being able to treat and accommodate patients with disabilities. Finally, we're working on a sexual and gender minorities sub-questionnaire as well, an SGM-sub questionnaire that will be sometime into the new year.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how the guidance should prompt better-designed oncology trials and greater diversity. 

Future Impact of FDA’s Multiregional Clinical Trials Guidance

, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA's new guidance for multiregional oncology trials, emphasizing the need for diverse patient populations in clinical trials. The guidance requires companies to proactively plan trials to ensure data applicability to the US population, considering factors like patient characteristics and healthcare systems. The expected outcome is better-designed trials with broader access and representation.

A transcript of Kahsoki’s conversation with

ACT: Looking forward, what do you think the future impact of this guidance will be?

Well, ultimately, I'm hopeful. I'm always encouraged by new guidance. I think guidance represents the progressive thought, the advancement of new ideas, the solidification of advice and experience and embeds into practice the drug development that we all are engaged in. Ultimately, I think that the guidance is going to result in even better-designed oncology, multiregional trials. I think these will be conducted in a wide range of sites and locations, and yield information that is helpful across the globe. In the US specifically, I think the most visible, maybe even the more immediate impact will be where the trials are run. We'll begin to see, as I mentioned earlier, diversification of investigators, and we're going to see a diversification of study participants. People are going to have to talk even more with one another, so the community-based healthcare providers talking about their needs, their systems, how to integrate with maybe some of the complexities that may be required for clinical trials that will need to be adapted, perhaps. Overall, it opens the door wider, I think, to oncology patients to receive investigational oncology products as a therapeutic option. Hopefully it’s better for all.

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