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# Lifting Barriers to Transgender People in Cancer Trials
- URL: https://www.fdaweb.com/lifting-barriers-to-transgender-people-in-cancer-trials/
- Published: 2022-11-03T12:00:00.000Z
- Updated: 2026-09-14T18:05:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153124

FDA and academic researchers say there are steps that can be taken to support the inclusion of transgender people in oncology trials. Writing in the *Journal of Clinical Oncology*, the authors say at least 1.6 million transgender people are living in the U.S. and more than 400,000 will be diagnosed with cancer in their lifetimes.

“Transgender people experience systemic oppression, poverty, violence, and discrimination in medical settings,” the article says. “All these factors may lead to late-stage cancer diagnoses. Consequently, transgender people may experience worse survival outcomes compared with their cisgender counterparts.”

The FDA Oncology Center of Excellence sponsored a 2020 symposium to **(1)** discuss barriers to cancer clinical trials for transgender and other sexual and gender minority people with cancer and **(2)** explore ways to address these barriers in the context of oncology drug development.

Arising from those discussions is a framework for the inclusion of transgender people in clinical trials:

- replace the practice of interchangeable use of sex and gender with data collection that reflects these concepts as distinct and allow for the collection of data on disease-relevant reproductive anatomy, gender, relevant physiologic factors, etc.;
- replace presumptive language linking gender to cancer type with more inclusive language;
- implement protections to decrease stigmatization of transgender people within cancer centers;
- allow individuals who are living with HIV to participate in clinical trials with exceptions made only when clinically or scientifically indicated; and
- allow individuals who are receiving hormone therapy to participate in clinical trials with exceptions made only when clinically or scientifically indicated.