STARR Diversity Workgroup

Objective: Identify cultural barriers to research participation and develop culturally-appropriate activities to overcome those barriers.

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:

  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.”

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