The Era of Diversity Action Plans is Here: Are You Ready?
Increasing clinical trial diversity has become a top priority for many pharmaceutical companies in recent years. With the FDA soon to finalize guidance on mandated Diversity Action Plans for phase 3 trials, Rx4good and Pyxis Partners have joined forces on an offering to help companies navigate the evolving landscape of both the requirements and the opportunities to ensure representation in clinical trials.
In the Q&A below, Rx4good’s Heidi Adams invites Pyxis’ Bobby Clark and Ronnie Tepp, and Rx4good’s Rebecca Block, to share their expert perspectives on the complexities of the challenge and the critical elements of effective solutions for increasing clinical trial diversity.
First, a quick overview of Diversity Action Plans (DAPs):
The Food and Drug Omnibus Reform Act (FDORA) was enacted by Congress in December 2022, and mandates that manufacturers of drugs and devices provide the Food and Drug Administration (FDA) with DAPs. These plans must detail strategies for recruiting a varied cohort of participants for phase 3 and other studies. The recruitment targets should be broken down by age, sex, and the racial and ethnic composition of the study groups that are clinically significant, and can also consider factors such as geographic location and socioeconomic status.
In April 2022, FDA had issued draft guidance on the composition of DAPs. Per the new law, the agency was required to publish or revise guidelines regarding the specifics of these diversity plans by December 2023. While the agency convened a public workshop to solicit input from stakeholders on clinical trial diversity, it has yet to finalize the guidance documents required under FDORA and is coming under increasing pressure to do so.
Heidi Adams: Let’s discuss DAPs and what you see as the obstacles for pharmaceutical companies in delivering on them?
Ronnie Tepp: Nothing about conducting clinical trials is easy. Adding effective DAPs into the mix requires a shift in thinking and approach. Initially, DAPs may complicate the recruitment and reporting process – particularly for difficult- to-recruit trials. A commitment by grassroots communities, industry and regulators is needed to ensure we are working together to change mindsets, define new approaches and build momentum for DAPs through as much collaboration as possible, as efficiently as possible.
Rebecca Block: Totally agree. DAPs require a shift in thinking from recruiting numbers of patients to recruiting individuals who have varying lived experiences and cultural norms (both in and out of healthcare), and differing logistical needs and priorities. Heterogeneity is the goal, not sheer numbers.
Heidi Adams: Can you talk about community engagement and DAPs?
Bobby Clark: There are two key components to DAPs: technical aspects and community engagement. When addressing the technical components, approaches such as decentralized trials or mobile technologies are methodologies that have shown results and will continue to evolve to make trial participation easier.
Ronnie Tepp: Community engagement, on the other hand, takes time and investment to build and nurture a foundation of trust. It’s about creating mutually beneficial, long-lasting relationships in communities that are skeptical of the biomedical research enterprise. Industry must be prepared to sustain bidirectional and ongoing dialogue and make investments in building and sustaining these relationships. This is about taking the longer view, building a sustainable and scalable engagement infrastructure that will yield a quantifiable return beyond just one trial.
Rebecca Block: We also need to understand well before phase 3 what representation looks like within an indication. We need insight-driven research that illuminates both the epidemiology of the disease and the human dimensions of being a person living with a disease. Understanding and acknowledging the significant differences between different disease states will inform how this research is approached and results are interpreted, and the more we can do to make this research widely available, the better we all will become at running diverse, inclusive and eventually equitable clinical trials.
Heidi Adams: What about the obstacles within clinical trial sites? Are they sufficiently prepared to ensure diversity in trials? What about CRO’s?
Bobby Clark: Research shows that selecting the right clinical trial site benefits enrollment and retention. Innovative technical approaches such as decentralized trials are a great step towards addressing some site location challenges. As important is engaging representative communities early in pre-clinical and clinical development; incorporating their ideas can help inform approaches to ensuring an enrollment site is not a barrier to enrolling and retaining study participants. In addition to sponsors investing in community engagement, it would benefit the biopharma ecosystem if local institutions and CROs also invested in building localized community engagement teams at each site who know their communities the best and are well positioned to work with them.
Rebecca Block: We also envision a proliferation of services to support enrollment and participation of patients and families new to trials (and potentially new to engaging so heavily with healthcare). Preparing trial sites and CROs requires education, training, support, and services specific to the disease state, which requires local knowledge and access to organizations that are able to deliver local services and/or scale or coordinate nationally.
Heidi Adams: Rx4good and Pyxis Partners are two distinct firms with two distinct missions. What strengths do you see that our combined organizations have on this issue that others don’t, and what do you want to solve in our collaboration?
Rebecca Block: Rx4good brings deep experience in working with industry, particularly on increasing clinical trial diversity in the context of how drug development works, what the goals are, and the challenges industry faces. We also have a deep understanding of the patient experience and perspective on the barriers that limit participation in clinical trials. And we know how to create safe spaces with patients and communities for important conversations about research and clinical trials.
Ronnie Tepp: Pyxis Partners has deep knowledge of hyper-local community organizations and what matters to them that we want to harness to problem-solve in this area. Having these perspectives enables our firms to develop and drive patient- and community-driven strategies that align with industry goals.
Bobby Clark: What we SHARE is a vision where patients, their perspectives, and what matters most, are always first when it comes to drug development. It’s a natural collaboration to leverage our strengths to help industry meet the new FDA guidelines when it comes to diversifying clinical trials.
If you’d like to explore working with Rx4good and Pyxis Partners, please contact Ann Moravick (ann.moravick@rx4good.com) or Bobby Clark (bclark@pyxispartners.com)
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Rx4good is a virtual global firm specializing in patient engagement and patient advocacy to advance what’s humanly possible in healthcare, working with companies, government, academia and nonprofits to forge partnerships that improve the lives of patients.
Pyxis Partners is the leading Washington, DC-based public affairs and social impact firm that advances health equity, access and affordability with unique expertise in authentic work around equity, diversity and inclusion in the healthcare and clinical trial universe.
