Published on: June 11, 2024 and updated on May 30, 2025
Abstract: All study participants should be able to see themselves in the research data. However, standard demographic variables of sexual orientation and gender identity (SOGI) have rarely been reported for clinical trials. We therefore don’t know whether LGBTQIA+ people are able to participate in clinical trials, or whether the safety and efficacy of tested products differs for any LGBTQIA+ participants. To begin to address this gap in respect for participants, study generalizability, and beneficence, the National Institutes for Health and Institute for Medicine now recommend collecting SOGI data. To support research teams, sites, and sponsors in following this recommendation we developed the SOGI Data Collection Checklist.
This SOGI Data Collection draws together key points from published guidance and the insights of LGBTQIA+ Inclusion by Design in Clinical Research Working Group members who have been leading in this field and piloting survey methodology. It provides prompts to think the process of SOGI data collection, which includes steps like defining the purpose of the data collection, mapping the proposed data elements, and working with groups and/or advisory boards that are inclusive of people who are lesbian or gay, and people who are transgender, non-binary, or intersex. While we do not provide standardized data collection questions (e.g., gender identity, sex at birth), response choices (e.g., [for sexual orientation] lesbian or gay, straight, bisexual, other), and response formats (e.g., open response), we do provide references with links to current guidance. Finally, please note that this SOGI DATA Collection Checklist is meant to be utilized in tandem with the SOGI Data Privacy Checklist.
Learn how four organizations, Mass General Brigham (MGB) Rally, HonorHealth, the Society for Clinical Data Management (SCDM), and the CureMito Foundation, are implementing the MRCT Center’s Clinical Research Glossary and how you can participate in Public Review, a vital process to ensure the glossary is a CDISC global standard.
Description: New requirements for clinical trial sponsors to submit diversity action plans to the US Food and Drug Administration (FDA) are an important step to embed planning for diverse representation in clinical trial research. These must not, however, be implemented in ways that are detrimental to other countries’ health and research interests. It is possible for those making operational decisions on country and site selection to address the needs of underserved populations in other countries at the same time as meeting US regulatory expectations — for example, by addressing barriers to diverse recruitment. Site selection should follow purposeful engagement in the local and regional culture, considering the needs of the local population, and proceed only if the trial is responsive to those needs.
Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes. Despite recent legislative efforts to improve diversity in clinical trials, and many individual organizational efforts, a national plan to include diverse patients does not exist.
Please note, the 4th [hybrid] meeting in this series, entitled “Toward a Framework to Improve Diversity and Inclusion in Clinical Trials,” will be hosted by NASEM in Washington DC on May 20. You can find out more information and register here. This workshop will build on the National Action Plan. We will be focusing on commitment to strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development.
Comments provided to: U.S. Food and Drug Administration
The MRCT Center submitted public comments to the FDA on its draft guidance on the use of data monitoring committees in clinical trials (Docket #FDA-2001-D-0219). In broad strokes, our comments recommended expanded guidance on the role Data Monitoring Committees can play in actively fostering the safety of trial participants – whether by communicating directly with trial sponsors, IRBs, or with offices within FDA. We also offered critical feedback on specific sections of the draft guidance that seemed incomplete or appeared to contradict other guidance from the FDA. As with all our interactions with the FDA, we commend their commitment to setting the global pace when it comes to ensuring the conduct of scientifically sound, risk appropriate, ethical clinical research.
The MRCT Center submitted a response to a draft ethics charter intended to protect healthy volunteers in clinical trials published by the French National Institute of Health and Medical Research (“INSERM”). The draft ethics charter consisted of 17 proposed articles; the MRCT Center offered general commentary on the entire charter and provided feedback and/or recommended new language on 14 of the 17 articles. Broadly, the MRCT Center wholly supports the development of an ethical charter to protect healthy trial participants. Our comments reflected our support for the broader endeavor while remaining dedicated to helping INSERM craft language that reflects their well-intentioned goal.
