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;
- Cultural Tenets: exploration of broad range of tenets, including but not limited to, race, ethnicity, gender, sexual orientation, socio-economic, geographical, religious preferences;
- Research how diversity influences effective clinical research.
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 met once a month to discuss project needs, ideas and scope of work. An online platform will be used to share information, communicate between monthly 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 setting the agenda and leading the bi-monthly workgroup calls with the co-chairs and helping establish and drive the output for the group between calls.
Deliverables:
- 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.
- Multimedia presentation on “What is Cultural Competency?”
- Build out the Diversity Module as part of the STARR Site Certification, starting by defining measurable objectives for site training.
Deliverables Created:
Links:
- FDA’s Guidance on Diversity in Clinical Trials
- NIH Diversity & Inclusion in Clinical Trials
- 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.”
NOTE: This is an active workgroup and this page is updated regularly.
Letitia Griffin (Co-chair)
CNS Healthcare
Shishuka Malhotra (Co-Chair)
Neuro-Behavioral Clinical Research
Temitope Keyes (Co-Chair)
Adaptive Clinical Systems
Molly Little
Neuro-Behavioral Clinical Research
Inez Ruiz-White
Otsuka
Zach Mitchell
iResearch Atlanta
Kimberly Wolf
Synergy San Diego
Patrick Ezeh
Biogen
Nadine McLeod
Biogen
Poorvi Chablani
Biogen
Leslie Franceschi
Franceschi Clinical Research Consulting
Sarah Titus
Sage
Jacob Silberstein
Sage
Taylor McCleod
Sage
Van Johnson
Benchmark Research
Nichole Gutierrez
Pillar Clinical Research
Tricia Gunter
ONO Pharma
Jennifer Gaskin
(formerly Centrexion)
Irena Webster
Forma Therapeutics
Luke Kramer
ERG
Chuck Wilcox
Praxis Research Consulting
Omar Moreira
Segal Trials
Amy Schemer
CNS Healthcare
Kimberly King
DBSA
Matthew Shapiro
NAMI NY
Carol Witham
The STARR Coalition
Mallory Mercer
The STARR Coalition
Erica Moore
The STARR Coalition