STARR Diversity Workgroup

Workgroup Mandate: Support Diversity, Equality, and Inclusion 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 within diverse communities;
• Best practices guidance document and checklist;
• Metrics that will help measure progress and objectively evaluate outcomes;
• Cultural Tenets: exploration of broad range of tenets, including but not limited to, race, ethnicity, gender, sexual orientation, socio-economic, geographical, religious preferences.

Objective: Educate diverse 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?

• 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.

• FDA Draft Guidance
• News article: Diversity Requirements
• Congressional Food and Drug Omnibus Reform Act (FDORA) article
• Summary and Analysis of FDORA

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