Diversity Action Plan (DAP): Creating An Ecosystem For Success

By Devra Densmore, founder and principal consultant, Elevate Advocacy

Diversity Action Plans (DAPs) are a hot topic in the clinical development process, particularly now that the FDA released in June 2024 its revised guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This updated draft provides a much more robust blueprint for what is expected from clinical study sponsors. What is missing, however, and what some sponsors have not yet realized, is that DAPs do not exist in a vacuum. The most successful plans are developed within an ecosystem that lends itself to supporting new and ambitious ways to engage study participants who have historically not been part of clinical research but who have been disproportionately burdened by disease.

Through longitudinal qualitative research, including in-depth interviews and collaborations with pharmaceutical and biotechnology companies of different size market caps, employee sizes, and therapeutic focus (i.e., rare and high prevalence disorders), nine best practices have emerged that, when implemented, can improve the likelihood of developing a successful DAP.

In this two-part series, we will explore how to write a successful DAP and how to create an environment in which a successful DAP can be written and executed.

The Importance Of Creating A Diversity Ecosystem

DAPs are essentially an operationalized map detailing how a sponsor and its partners (CROs, sites, community organizations, advocacy organizations, and communications agencies) will attempt to reach articulated enrollment goals for the study. A DAP is not a diversity strategy. This does not mean the DAP is not strategic. It must be to be successful. However, a DAP should be in support of, and provide a ladder up to, the sponsor’s program strategy, its asset strategy, and its broader diversity strategy. Some sponsors have confused a DAP with a diversity strategy, signaling a lack of understanding of what a DAP’s purpose and value are and the difference as compared to a broader diversity strategy. It is critical to have clarity about the difference.

As previously mentioned, a DAP is an operational map detailing how a sponsor and its partners will attempt to reach articulated enrollment goals that align with epidemiology and the disproportional impact some populations experience within that disease state.

Alternatively, a diversity strategy details a company’s commitment to diversity, equity, and inclusion (DEI) throughout the enterprise. This includes how DEI will impact internal and external policies and engagement. From human resources to vendor selection to external stakeholder engagement (KOLs, patient advocacy groups, healthcare professionals, and environmental, social, and governance investing frameworks), a diversity strategy is foundational to the culture of the enterprise by formally codifying that commitment.

It will be essential to the development of a successful DAP to have this enterprise-wide strategy in place so that there is a socialized framework throughout the enterprise that aligns every department within the enterprise around the value of DEI to the enterprise’s success. Without such a strategy in place, there can be a lack of understanding, commitment, and accountability, which can lead to inconsistent quality among DAPs, as well as inefficiencies and wasted time and money.

The following nine best practices have been shown to improve the likelihood of developing a successful DAP among multiple diverse clinical trial sponsors.

9 Best Practices For Implementing A Successful DAP

1. The enterprise's leadership has endorsed an enterprise-wide diversity (DEI) strategy and DAPs as part of each program’s remit.

• The executive leadership team (ELT) is committed to a DEI strategy and DAPs.
• The ELT commitment has been cascaded down through departmental and reporting structures.
• DAPs are socialized as essential parts of research and development, which extends to the commercial enterprise.
• The appropriate infrastructure can now be created due to executive sponsorship.

2. The enterprise develops a DEI strategy.

• Remember: DEI strategy and DAPs are not the same.
• The DEI strategy is a leadership-endorsed, clearly defined, and socialized strategy for the enterprise.
• Departmental, program and asset-level DEI strategies, initiatives, and tactics should provide a ladder up to this enterprise strategy. DAPs are part of the program-level initiatives and tactics but are not interchangeable with the DEI strategy.
• This strategy should define the enterprise’s commitment to DEI and influence other business strategies.

3. The study sponsor takes ownership of each DAP.

• The sponsor leads the DAP’s development, not CROs or sites; CROs and sites execute according to the DAP (similar to executing a trial protocol).
• Accountability for DAP development is clearly understood by the program team.
• Responsibility for the DAP is embraced and not passed around like a “hot potato” (via RACI [responsible, accountable, consulted, and informed] or other formal policy).
• Program teams understand the expectation and need for DAP planning well before Phase 3 or pivotal stage study, ideally in pharmacokinetics/pharmacodynamics (PK/PD) or safety studies.
• Performance goals and bonus structures are tied to DEI strategy and DAPs.

4. Sponsors should have a DEI infrastructure in place throughout the enterprise, including the program team.

• Formal and informal policies, processes, systems, and tools are:
  • available and readily accessible throughout the organization,
  • socialized for clear understanding and adoption,
  • supported by updates, efficiencies, and best practices that are clearly communicated for process and operational improvements (via learning and resource management), and
  • evaluated by a formal review committee that ensures quality, consistency, and alignment with the DEI strategy.

5. Roles and responsibilities are clearly defined via a RACI that has been:

• developed and socialized so that every DAP contributor knows their role and what they are accountable for,
• endorsed by leadership so that expectations are clearly understood throughout the larger, matrixed enterprise (for functional line leader accountability)
• actively leveraged by the program team, and
• communicated clearly to the CRO and all other operational contributors so that they understand their performance is tied to the DAP.

6. Program teams are integrated to collaboratively develop and execute the DAP.

• The program team contributes to collectively create a well-informed and operationalizable DAP.
• DAPs should be planned with enough time for program team members to review them individually then provide feedback and discuss them collectively.
• While the program team is ultimately responsible for a DAP, enterprise and asset leadership should be integrated into the process for validation, optimization, alignment, and review.
• CROs, sites, and study vendors should be aligned with planning to help inform the development and execution of a DAP and identify potential challenges.

7. DAPs need appropriate resourcing.
   • DAPs should be discussed at the program start. Planning should include staffing (studies, program, community engagement, and advocacy) and financial resources, which include proper
     • epidemiological understanding and gap analyses,
     • early-phase study representation,
     • diverse patient journey mapping,
     • patient and community engagement and investment,
     • diverse healthcare provider (HCP) and principal investigator (PI) engagement,
     • diverse vendor selection (if not previously sourced), and
     • site mapping in historically underrepresented communities.

8. The sponsor has a deep understanding of the patient community.

• Both qualitative and quantitative data should be carefully curated and evaluated to understand the burden of disease, the unmet need, and the epidemiological data.
• Data should be varied and include non-traditional sources to identify potential bias in literature (particularly in rare disease), as well as provided to and evaluated by a cross-functional group of contributors.

9. Culturally competent community engagement is prioritized throughout DAP development and execution.

• The sponsor’s internal staffing should be diverse and representative of many different lived experiences.
• The selection criteria of CROs, vendors, and community partners should include:
  • experience successfully operationalizing diverse clinical trials,
  • ownership and staff reflective of historically minoritized communities,
  • proven successful community engagement, and
  • training modules and tools to appropriately equip sites to be more inclusive and equitable.

Collectively, these best practices can create an ecosystem for a program team to thrive and a DAP to succeed. It is important for organizations, no matter what their size, to become familiar with each of the practices, starting with one and working to operationalize the rest. Even the smallest of companies in the clinical stages have demonstrated an ability to start with one best practice and integrate the others into their organizations. It is better to methodically move through the best practices than to ignore that they are needed to optimize enrollment goals of a trial and FDA interactions.

Join us for part two of this series, as we explore specific ways to create successful DAPs, and for an interactive webcast to address questions related to DAP development and execution.

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.