The TIDE-Asthma study has identified effective strategies for increasing racial and ethnic diversity in clinical trials, according to findings presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting. The study, a phase 2 trial assessing amlitelimab for moderate to severe asthma, successfully met its diversity enrollment goals by implementing targeted outreach and support initiatives.
Monique Adams, PhD, executive director, global head, diversity and inclusion in clinical trials at Sanofi, emphasized the critical impact of race and ethnicity on asthma-related outcomes. "For asthma, race and ethnicity have a significant impact on asthma-related mortality, morbidity and hospitalization rates," she stated, highlighting the importance of representative patient populations in clinical trials.
Strategies for Diversity and Inclusion
The TIDE-Asthma study employed several key strategies to enhance diversity and inclusion (D&I) in its enrollment process. These strategies included:
- Awareness and Outreach: Engaging key opinion leaders (KOLs) within diverse communities to raise awareness about the study.
- D&I-Focused Site Selection: Identifying and selecting clinical trial sites in cities with high asthma prevalence and access to diverse populations.
- Site and Patient Support: Providing regular updates on enrollment status, sharing success stories, and offering solutions to address enrollment challenges.
Adams noted that many of the selected sites were new to Sanofi, emphasizing the importance of partnering with trusted messengers already embedded in the target communities. Site questionnaires were used to assess D&I considerations during site feasibility discussions, and D&I goals were consistently addressed throughout the trial.
Overcoming Barriers to Enrollment
The study team recognized and addressed the financial burdens that often hinder participation in clinical trials. Transportation support and hotel accommodations were provided to alleviate these barriers.
Enrollment Results and Impact
The TIDE-Asthma study enrolled a total of 446 patients globally, with 83 patients from the U.S. The study successfully achieved its diversity enrollment goals for all racial groups in the U.S., with particularly strong representation from Hispanic and Asian patient populations. Specifically, the racial breakdown included 16% Black/African American, 46% Hispanic, 5% Asian, and 33% patients of other races/ethnicities.
Adams explained that the success in achieving diversity goals ensures that study data accurately reflects treatment outcomes in diverse patient groups, thereby reducing bias. The lessons learned from the TIDE-Asthma study are now being applied to other clinical trials at Sanofi, across various therapeutic areas.
About Amlitelimab and TIDE-Asthma Trial
The TIDE-Asthma study is a phase 2, parallel, global, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of amlitelimab (Sanofi) as an add-on therapy for adult patients with moderate to severe asthma. Amlitelimab is an anti-OX40L monoclonal antibody. The diversity and inclusion goals were based on asthma prevalence in the U.S., according to TriNetX, primary literature and the U.S. Census Bureau.
