Breaking barriers: SOGIIS data collection for improved health equity in clinical trials

Diversity in clinical trials is crucial to reduce health inequities and enhance the effectiveness, safety and outcomes of medicine. Additionally, it is critical for ensuring drug efficacy across varying patient populations. Bristol Myers Squibb (BMS) is at the forefront of this effort, addressing historical gaps in data collection concerning sexual and gender minorities. These gaps have previously hindered initiatives to tackle health disparities related to sexual orientation, gender identity and intersex status (SOGIIS). Reflecting our dedication to the diverse communities we serve; we have established specialized cross-functional teams across drug development focused on SOGIIS data collection. These teams work to optimize data collection and data standards and liaise with clinical teams for individuals undergoing gender-affirming care and to develop appropriate language for clinical trial sites with input from volunteers from our PRIDE and OLA People Business & Resource Groups and members of the LGBTQ+ community. 

SOGIIS began as a grassroots effort within BMS, initiated by our PRIDE PBRG with additional insights from the OLA PBRG on Latinx patients. This initiative, envisioned by our LGBTQ+ employees and allies, was first operationalized and piloted in the U.S., focusing on clinical trial data collection. The SOGIIS effort is now expanding globally. Moving forward, we are focused on increasing the percentage of racially and ethnically diverse patients enrolled in clinical trials across indications, including lupus, multiple myeloma, pulmonary fibrosis and Alzheimer’s disease. We recognize there is much work ahead to broaden these efforts beyond the U.S.

Addressing the health disparities affecting the LGBTQ+ community have been a key area of focus at BMS. That is why we implemented voluntary self-identification of LGBTQ+ characteristics through an electronic device in a private setting in clinical trials across therapeutic areas for U.S. adult trial participants. BMS began collecting SOGIIS data in 2022 from adult patients within the U.S. who voluntarily self-identify, using electronic patient report outcome (ePRO) methodology. All eligible trials that are recruiting adult patients in the U.S. and utilizing an electronic device to report patient-reported outcomes will offer the patient the option at the end of the first visit to privately disclose sexual orientation, gender identity and intersex status. Allowing adult patients to self-identify their sexual orientation, gender identity and intersex status is a major stride in fostering a more inclusive approach to clinical trial research.

Leveraging AI for inclusive and representative clinical trials

As part of our commitment to prioritizing greater diversity and representation in clinical trials, we leverage the abilities of AI to integrate simulated data from underrepresented patient populations when such data is not immediately available. Research that is inclusive of a wide range of people will more effectively help us understand and aid those in underserved communities. By better addressing barriers to achieving health equity and making the clinical trial space one for all, BMS can continue growing and innovating to reflect the populations we serve. 

Our commitments

We are dedicated to promoting health equity by ensuring our clinical trial populations mirror the demographics of patients most affected by the diseases we target, thereby improving treatments and outcomes for underserved communities and enhancing our understanding of treatment safety and efficacy across different groups. Our focus is aimed at increasing clinical trial diversity, including the representation of underrepresented racial, ethnic and LGBTQ+ communities, and have located 58% of our U.S. research sites in diverse areas. As an inclusive, patient-centered biopharmaceutical company, we are committed to doing our part to help ensure that everyone has a fair and just opportunity to achieve optimal health outcomes.