A 50+-member, international, multi-stakeholder workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center) developed this Guidance Document and accompanying Toolkit. While every member contributed to the development of the Diversity Framework, the leadership of the MRCT Center is responsible for the final content.
The views and findings expressed in this document are those of the authors and do not imply endorsement or reflect the views or policies of the U.S. Food and Drug Administration or the affiliated organization or entity of any member who contributed to this work. Individuals have served in their individual capacity.
- RADM Richardae Araojo, U.S. Food and Drug Administration (as of August 2018)
- Barbara E. Bierer, MD, MRCT Center
- Luther T. Clark, MD, Merck & Co., Inc.
- Milena Lolic, MD, U.S. Food and Drug Administration (August 2019 – August 2020)
- David H. Strauss, MD, Columbia University
- Junyang Wang, MSc, U.S. Food and Drug Administration (until August 2019)
- Sarah White, MPH, MRCT Center
- John Whyte, MD, MPH, U.S. Food and Drug Administration (until August 2018)
MRCT Center staff:
- Carmen Aldinger, Administrative & Training Manager
- Hayat Ahmed, Project Manager
- Laura Meloney, Program Manager
- Joshua Smith-Sreen, Student Researcher
| Name | Organization |
| Maria Apostolaros | Pharmaceutical Research and Manufacturers of America (PhRMA) |
| Abhijit Bapat* | Novartis |
| Stacey Bledsoe* | Eli Lilly and Company |
| Shari Bodnoff* | Novartis |
| Racquel Bruton | Biogen |
| Elizabeth Cahn | Cancer Connection |
| Li Chen | Amgen |
| Patrick Cullinan | Takeda, currently BlueBird Bio |
| Liza Dawson* | National Institutes of Health (NIH) |
| Maria De Leon* | Parkinson’s Foundation |
| Theresa Devins | Boehringer Ingelheim, currently Regeneron Pharmaceuticals |
| Anthony Edmonds | Takeda |
| Rhonda Facile | Clinical Data Interchange Standards Consortium (CDISC) |
| Rachael Fones | IQVIA |
| Laura Gordon* | Institute for Advanced Clinical Trials for Children (iACT) |
| Anya Harry | GlaxoSmithKline (GSK) |
| Melissa Heidelberg | Genentech/A Member of the Roche Group |
| Quita Highsmith | Genentech/A Member of the Roche Group |
| Sharareh Hosseinzadeh | Novartis |
| Lloryn Hubbard* | Genentech/A Member of the Roche Group |
| Anne Marie Inglis* | GlaxoSmithKline (GSK), currently Mallinckrodt Pharmaceuticals |
| Aarthi B. Iyer* | Kinetiq, now Advarra |
| Becky Johnson* | IQVIA |
| Tesheia Johnson | Yale School of Medicine |
| Jonathan Jackson* | Massachusetts General Hospital |
| Marcia Levenstein | Vivli |
| Roberto Lewis | Columbia University |
| Eldrin Lewis | Brigham and Women’s Hospital, currently Stanford University |
| Jianchang Lin* | Takeda |
| Erin Muhlbradt | National Cancer Institute (NCI) |
| Isabela Niculae * | Biogen |
| Latha Palaniappan | Stanford University |
| Claude Petit | Boehringer Ingelheim |
| Claire Pigula* | Biogen |
| Melissa Poindexter* | Advances in Health |
| Nicole Richie | Genentech/ A Member of the Roche Group |
| Bryant (Abel) Riera* | Population Council |
| Suzanne M. Rivera | Case Western Reserve University |
| Frank W. Rockhold | Duke University |
| Ricardo Rojo* | Pfizer |
| Rosanne Rotondo* | Novartis |
| Fabian Sandoval | Emerson Clinical Research Institute |
| Richard Sax* | IQVIA |
| Hollie Schmidt | Accelerated Cure Project for Multiple Sclerosis |
| Karlin Schroeder | Parkinson’s Foundation |
| Mary Scroggins* | Pinkie Hugs |
| Jessica Scott* | Takeda |
| Lana Skirboll | Sanofi |
| Steven Snapinn | Seattle-Quilcene Biostatistics |
| Stacey Springs* | Harvard Medical School |
| Sara Tadesse-Bell | Genentech/ A Member of the Roche Group |
| Ann Taylor* | Columbia University |
| Paul Underwood | Boston Scientific |
| Junyang Wang* | Food and Drug Administration (FDA) |
| Robert Winn* | University of Illinois |
| Gerren Wilson* | Genentech/ A Member of the Roche Group |
| Crispin Woolston | Sanofi |
| Honghui Zhou* | Johnson & Johnson |
*involvement limited in time
- Mark Barnes, Ropes & Gray and MRCT Center
- Maria DeLeon, Parkinson’s Foundation
- David Hawks, National Council of Asian Pacific Islander Physicians and Alliance of Multicultural Physicians
- James H. Powell, Strategic Medical Associates
- Matthew Rotelli, Eli Lilly and Company
- William Tap, Memorial Sloan Kettering Cancer Center