Advancing LGBTQIA+ Representation: The FDA’s Role in Inclusive Diversity in Clinical Trials

The FDA hosted a roundtable in June 2024 to increase LGBTQIA+ representation in clinical trials. Attendees included healthcare professionals, researchers, LGBTQIA+ advocates, and members of the Racial and Ethnic Minority Acceleration Consortium for Health Equity (i.e., the REACH consortium). The focus was on identifying the barriers that sexual and gender minorities face in clinical trial participation and on proposing solutions to make research more inclusive.

One significant barrier discussed was the lack of inclusive screening processes. Current forms often exclude non-binary and transgender identities, leading to underrepresentation. Additionally, many in the LGBTQIA+ community are unaware of clinical trials, particularly those addressing their unique health concerns. Informed consent forms often use language that doesn’t adequately reflect this population’s needs, discouraging participation.

The importance of diversity in clinical trials

Lack of diversity in clinical trial cohorts can have profound implications for public health. If the participants of these trials are primarily from one specific demographic, the outcomes may not accurately reflect those of the wider populace. This may lead to medications and therapies that are less beneficial or potentially detrimental to certain population subsets.

How is the FDA increasing diversity in clinical trials?

To tackle these issues, the FDA is committed to creating more inclusive screening tools that recognize diverse

sexual orientations and gender identities. This will help make trials safer and more welcoming, ensuring that data reflects the populations most impacted. The roundtable also emphasized the importance of working directly with LGBTQIA+ organizations and local health centers to raise awareness and improve recruitment.

Education for healthcare professionals was another critical topic. Many clinicians lack training on LGBTQIA+ health issues, making it harder for them to support patients interested in clinical trials. Providing more educational opportunities for these professionals is key to improving representation.

Scott D. Crawford, founder of SoundRocket, praised the FDA’s initiatives: “You can’t solve health disparities if your research isn’t inclusive,” he said. “The FDA’s push for greater LGBTQIA+ participation in clinical trials is moving in the right direction.”

As for the next steps, to start to develop a framework for more inclusive clinical trials, the FDA plans to strengthen partnerships with LGBTQIA+ organizations, develop inclusive policies for data collection, and increase educational efforts to ensure healthcare providers are better prepared to support LGBTQIA+ patients in clinical trials.