STARR Voices in Research Workgroup

Objective: Identify regional (cultural) barriers to research participation and develop appropriate activities to overcome those barriers.

Workgroup Mandate: Support All Voices in Clinical Research

Purpose: To create and provide educational and support tools for clinical research sites with the purpose of better engaging diverse communities in the areas they serve.

Description: Leaders across the research industry and advocacy will work to research, design and develop the following:

  • Tools to assist research sites to better work with all voices and communities;
  • Best practices guidance document and checklist;
  • Metrics that will help measure progress and objectively evaluate outcomes;

Objective: Educate communities on clinical research to build trust with our communities on the safety and efficacy around clinical research.

Specifications: Leaders from across the research industry and advocacy will meet quarterly to discuss project needs, ideas and scope of work. An online platform will be used to share information, communicate between meetings and serve as a central hub to formulate deliverables. Workgroup participants are encouraged to share information with peers and organizations to solicit feedback and suggestions for the workgroup.

Workgroup Co-Chairs:  Responsibilities include helping to set the agenda, lead the quarterly workgroup calls, and helping establish and drive the output for the group between calls. 

Deliverables:

  1. Develop guidelines and/or SOP’s on various cultural barriers and practical ways to overcome those barriers and engage each group in a culturally-thoughtful way.
  2. Multimedia presentation on “What is Cultural Competency?”
  3. Build out the Diversity Module as part of the STARR Site Certification, starting by defining measurable objectives for site training.

Deliverables Created:

  1. Diversity Resources area on website
  2. Diversity Pledge
  3. Site Diversity Measures Survey

 

Links:

  1. FDA’s Guidance on Diversity in Clinical Trials
  2. NIH Diversity & Inclusion in Clinical Trials
  3. Fierce Biotech article on diversity: “Here’s what the committee thinks equitable research looks like: a clinical trial population that matches the demographics of the disease being studied.”

 

Diversity Requirements Imminent: Age, Sex, Race — Are You Prepared?

(From the July 2024 STARR Newsletter)


The FDA’s draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials” was issued in April of 2022 to provide guidance and recommendations to sponsors for developing diversity plans to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the US.

Seven months later (in November 2022), Congress pushed things further forward by requiring sponsors to submit a diversity action plan with the study protocol to the FDA. This requirement, enacted under the Food and Drug Omnibus Reform Act (FDORA), will apply to clinical trials that commence enrollment 180 days after the FDA finalizes guidance on the topic, and requires the FDA to finalize the guidance within twelve months of its enactment — which means by the end of 2023.

The Act provides a lot of detail in what the guidance—and in turn, diversity action plans— should cover. Many of these details track what FDA already recommends in the April 2022 draft guidance. Diversity action plans should contain (1) the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic characteristics; (2) the rationale for these enrollment goals, including information about the disease or condition and its prevalence or incidence among various demographics; and (3) how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, inclusion and exclusion practices, and diversity training for study personnel.

What does this mean to sites?
  • Your database needs to include age, sex, and race.
  • Your community demographics information should be accurate, current, and supported by a source.
  • Your diversity engagement plan should include concrete plans and action-items.
  • You may need to be prepared to defend your diversity program.

That is the short list — there will undoubtedly be more requirements, but being prepared with the information above will prevent being caught-out next year, when the requirements will go into effect.

Sources:

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NOTE: This is an active workgroup and this page is updated regularly.

The STARR Coalition Diversity Workgroup focuses on inclusion where the system still falls short—addressing structural, experiential, geographic, and functional barriers that limit who can meaningfully participate in and benefit from mental health research.