Representation in Research
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People who are LGBTQIA+

Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. Yet, researchers rarely collect or report standard demographic variables for SOGI in clinical trials, as they do for other common demographic variables (e.g., age, race/ethnicity). We don’t know what we aren’t measuring, and therefore don’t know if people who are sexual and gender diverse (SGD) are being fairly included in trials or what the outcomes of trials are for SGD populations. We do know that people who are LGBTQIA+ experience discrimination in many areas of life, and some report not feeling welcome by healthcare providers and in clinical facilities.

While the existing portfolio of MRCT Center Representation in Clinical Research resources (e.g., Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, IRB/HRPP DEI Toolkit) has been widely used to reduce common barriers to trial participation, we are continuing to develop tailored resources where there are population-specific barriers to clinical research participation.

The MRCT Center has convened an LGBTQIA+ Inclusion by Design in Clinical Research working group, with voices at the table from across different clinical research stakeholder groups (sponsors, CROs, researchers, regulators), LGBTQ communities, and allies. This working group is endeavoring to complement existing resources in the clinical care and research spaces with resources to support LGBTQIA+ inclusion that have a focus on clinical research.

Related Assets

Please note: The tools in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit are living documents and will be improved with use. We welcome feedback, suggestions, useful references and resources, and concerns.

Acknowledgments

Many thanks to everyone who has so thoughtfully collaborated on these products. Members who have chosen to be publicly acknowledged are listed in the links below, with the titles and organizational affiliations that they had at the time of the product launch. Please note that each member served in their individual capacity, and the views and findings expressed 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.

Leadership

  • Dr. Barbara Bierer, Faculty Director, The MRCT Center
  • Dr. Willyanne DeCormier Plosky (she/her/hers), Program Director, The MRCT Center
  • Aaron Kirby, Bioethics Fellow, Harvard Medical School

Working Group

  • Batisha Anson, Global Head of Patient Diversity & Health Equity, Syneos Health
  • Todd Bazin, Head of Data Standards, Biogen
  • Amy Ben-Arieh, The Fenway Institute at Fenway Health
  • Isabel Brown (she/her/hers), Associate Global Clinical Trial Leader, Genentech
  • Andrew Camarena (he/him/his), MPH, Community Engagement and Recruitment Manager, The Fenway Institute
  • Ravina Cerreta-Dial (she/her/hers), VPM- Community Lead, PRIDE ERG Lead, Novartis
  • Savine DaCosta, Clinical Trial Diversity Site Lead, Biogen
  • Dr. Keith Dawson (he/him/his),Principal Portfolio Leader, Global Health Equity & Population Science Roche/Genentech
  • Marichu Endraca, Senior Global Trial Manager, CPO-Global Clinical Dev, Amgen
  • Dr. Frances Grimstad, Assistant Professor in Obstetrics, Gynecology, and Reproductive Biology, Boston Children’s Hospital
  • Dean J. Mariano, DO (he/him/his), Eli Lilly & Company
  • Meghan McKenzie (she, her/hers), Patient Inclusion and Health Equity, Chief Diversity Office, Genentech
  • Michelle Ouellette (she/her/hers)
DEI people DEI people DEI people DEI people DEI people DEI people DEI people DEI people DEI people
Global DEI DEI resources for IRBs/HRPPs DEI resources for IRBs/HRPPs People who do not speak English People with disabilities People with disabilities People with disabilities People who are LGBTQIA+ People who are LGBTQIA+ Financial neutrality for trial participation Financial neutrality for trial participation Financial neutrality for trial participation Pregnant and lactating people Pregnant and lactating people Pregnant and lactating people People with disabilities People with disabilities People with disabilities with disabilities
Underrepresented populations (in general) People who are LGBTQIA+ Pregnant and lactating people Financial neutrality for trial participation DEI resources for IRBs/HRPPs People with disabilities People who do not speak English Global DEI