Developing A Diversity Action Plan That Actually Works

By Devra Densmore, MPA, founder & principal consultant, Elevate Advocacy

In April 2022, the FDA issued guidance that all Phase 3 and pivotal studies include a Diversity Action Plan (DAP) as part of their data package. The guidance advised that, “This Plan should be discussed with the FDA as soon as practicable during medical product development. For drugs, this should occur no later than when a sponsor is seeking feedback regarding the applicable pivotal trial(s) for the drug (often during the End of Phase 2 (EOP2) meeting).” This recommendation has since been codified by Congress in Title III of the Food and Drug Omnibus Reform Act of 2022, which requires drug and device sponsors to submit DAPs articulating “goals for increasing enrollment of subjects from historically underrepresented populations.”

Then again, in August 2023, the FDA doubled down on this expectation by issuing Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products, which requires sponsors to collect data on historically underrepresented patient populations in post-market clinical trials when such information has not been able to be collected premarket.

This guidance is not particularly prescriptive, which leaves many clinical program teams uncertain about what exactly is needed to plan, create, and operationalize a DAP that meets FDA’s expectations. Without a clear path forward or an experienced partner to help develop these plans, industry may default to checking the box and developing plans that do not meet this important objective, thus exposing their programs to risk by falling short of FDA’s standards.

Where To Begin

A successful DAP requires a strategic approach that integrates the contributions of multiple cross-functional teams who are collectively well resourced. Therefore, it is imperative that during annual budget planning, the partners and tactics required to support your DAP strategy are adequately funded. A good DAP includes the integrated contributions of relevant cross-functional stakeholders, like clinical operations, chemistry manufacturing and controls (CMC), government affairs, health economics and outcomes research (HEOR), medical affairs, patient advocacy, regulatory, and translational sciences, into a clear and operationalized strategy. Plans should communicate in a cohesive narrative that details what systems, processes, and interventions have been taken leading up to the Phase 3 or pivotal study (e.g., pharmacokinetic/pharmacodynamics (PK/PD) and safety data collected in Phase 1 and Phase 2 studies) and how that information will inform additional interventions, processes, and tactics to be implemented during the Phase 3 study’s design and execution. Each tactic should have a clear rationale as to why it has been included in the plan, as well as a way to measure its impact to assess whether it was successful or needs to be adjusted.

To illustrate, one tactic a sponsor may choose to include within its DAP is to expand its evaluation criteria during the site feasibility process. In addition to standard criteria a CRO may use, the sponsor’s clinical operations and patient advocacy functions may co-create additional questions that explore how many potential participants a site estimates it can recruit from subpopulations historically underrepresented, yet disproportionately affected, by the disease. These criteria can help both the sponsor and site operate with greater intent for more inclusive engagement, which may ensure more appropriate and proportional patient representation at enrollment. Although not an infallible tactic, it provides three potential benefits beyond increased diverse enrollment:

1. This criteria weeds out sites early on who will not or cannot deliver on a sponsor’s commitment to implementing a successful DAP.
2. It holds a site to a standard for prioritizing diversity, equity, and inclusion (DEI) engagement.
3. It clearly demonstrates to the FDA a sponsor’s commitment to operationalizing a DAP and holding its research partners accountable to put the plan into action.

To effectively demonstrate their commitment, a sponsor, when evaluating sites, could justifiably de-prioritize a site that predominantly serves a homogenous population. Yet, if the sponsor wished to truly show a commitment to DEI that would benefit both its short-term goal of enrolling its current study and a long-term goal of having culturally competent sites for future studies, the sponsor and CRO could provide DEI/cultural sensitivity in medicine training to the principal investigator (PI) and site staff. Clinical Research Associates (CRAs), when doing quality checks, would include DEI-specific evaluation questions in their checklists, along with investigational medicinal product (IMP) storage requirements and other measurable standards of protocol compliance. Those formal measures and outcomes would be part of the CRA’s reports and could then be included in the final DAP narrative, which would be part of the NDA submission.

Where To Align

Next, your DAP should outline a realistic and accurate timeline for engagement and execution. Every DAP, no matter for what indication, will require sponsors to build relationships with partners in historically marginalized communities. This is imperative for any plan seeking to reach underserved patient populations. These partners should include patient advocacy organizations (PAOs), community-based organizations (CBOs), faith-based organizations (FBOs), and DEI leaders. It is essential to understand that engaging these partners requires a relational approach and that relationship building is not a transactional process and should not be undertaken like one. Getting to know a partner, including what their mission is, what is most important to them and to their constituents, and what their capabilities are (i.e., do they provide support, education, access, or clinical research information or all the above and more?) is foundational to aligning around shared objectives. This is a process that cannot be rushed, but the necessary time to build trust and authentically engage with partners is often not built into plans.

To appropriately and successfully engage in this new way requires understanding that longer timelines to build relationships with these key partners are highly likely, and that these partners often do not have the same resources and capacity to execute quickly or with little notice. When rushed or pushed, relationships are compromised and engagements become transactional, which limits the ability to build trust with advocacy, community, faith, and DEI leaders. Without trust, engagement plans are exposed to risk because there is no authentic reason for these leaders to buy into a DAP and the program it supports, share information with their constituents who may have active mistrust in the healthcare system or industry, or feel a sense of ownership or commitment to the potential benefit of the drug or device. Without that trust, buy-in is limited or compromised, and results are prone to be suboptimal.

This more relational approach may be a new way of thinking for program teams who are accustomed to working with vendors and engaging transactionally. Therefore, it is critical that teams begin to recognize the need and value for adopting new ways of working related to the DAP and plan their timelines accordingly.

Where To Assess

As clinical program teams assess the time, resources, and partners needed to successfully execute a DAP, it is critical that they ask questions to understand if they have the expertise available internally to adeptly integrate each functional group’s contributions into the plan and manage this integrated approach. Some key questions for program teams to ask their cross-functional leads include:

• Do you have a clear and accurate understanding of the epidemiological data associated with the indications treated by your asset?
• Is your PK/PD and safety data reflective of the diversity found in epidemiological data?
• Is your CRO including feasibility questions and considerations that will diversify the PIs and sites to include a more representative population and lessen the burden of trial participation?
• Does each site have the language and cultural competency necessary to recruit and retain diverse patients?
• Have the informed consent form (ICF) and protocol been evaluated by community members who will be the targets of your DAP? And have you incorporated that feedback into those foundational documents?
• Does your recruitment and retention strategy incorporate a strong advocacy and communications plan that includes underrepresented audiences?
• Who within your organization has built authentic relationships with key community-based, faith-based, and advocacy organizations trusted by historically underrepresented communities?
• Do you know how to create a compelling value proposition based on diverse data for discussions with the FDA, marketing, payers, and investors?

While this list is not exhaustive, it provides some important areas to identify where there may be gaps in the program’s approach. Gaps in the strategy will result in gaps in data, which may expose the program and organization to risks and waste including start-up and recruitment delays, additional studies, amendments, and bloated budgets.

When To Engage

With requirements that are new or unfamiliar, trial sponsors are increasingly vulnerable to risks due to limited experience. If your program team does not have expertise developing a DAP or managing the process around execution, engaging an external advisor who has created integrated DAP strategies and coordinated cross-functional accountability to implement the DAP can help accelerate the development of effective plans that yield real results and limit exposure to risk and loss. Delayed programs lose time and money, and identifying your program’s key needs for its DAP can help mitigate or eliminate the risks leading to loss and set your program up for success in this important area of inclusion within clinical trials.

About The Author:

Devra Densmore is the founder and principal consultant at Elevate Advocacy. Over her 20 years of patient advocacy and engagement experience, Devra has helped center diverse patient insights to improve health literacy and education initiatives, clinical trials in rare and common disorders, and treatment algorithms in hospitals inside and outside the United States. She and the team at Elevate Advocacy partner with drug and device sponsors to create effective and successful engagement strategies and DAPs. With decades of experience engaging diverse communities around health education and clinical research, Elevate Advocacy advises sponsors in DAP creation and execution while building meaningful, lasting, and differentiated relationships with these important community and DEI partners.