Diversity In Clinical Trials: LGBTQIA+ Community Needs Not Just Allies, But Crusaders

Diversity in clinical trials goes beyond race and ethnicity, encompassing factors like gender identity, age, and disability. The FDA's evolving regulations aim to improve the representation of historically underrepresented groups. While the FDA’s recent guidelines call for broader inclusion, LGBTQIA+ diversity remains inadequately addressed. Transgender health advocate Liam Paschall highlighted challenges like limited access, stigmatization, and inadequate recruitment strategies. He urged sponsors to adopt intersectional approaches and provide cultural competency training.

Johnson & Johnson (J&J) is leading with inclusive trials, such as the LIBERTAS study on prostate cancer, which employs degendered protocols to include transgender and nonbinary individuals. J&J also implements sexual orientation and gender identity (SOGI) data collection and provides culturally inclusive training for staff. Collaborating with LGBTQIA+ advocacy groups like the SGM Alliance, which focuses on inclusive clinical study protocols and combating discrimination, is crucial. Achieving true diversity requires ongoing efforts, cultural shifts, and inclusive trial designs that affirm marginalized communities.