Synergy in Action

Diversity in CNS Clinical Trials

Chairs: Abhishek Pratap, PhD; Siân Ratcliffe, PhD

Upcoming Activity: Working Group Meeting, 2024 Autumn Conference, 12-13 September 2024, San Diego, CA

This working group kicked off at the 2024 Annual Meeting, with the objective of addressing recent regulatory guidelines around diversity in clinical trials and methodological needs for CNS clinical trials to address patient population selection, enrichment and generalizability of these clinical trials.
In the forthcoming meeting, this working group will discuss stages of evidence generation during CNS preclinical and clinical development and how diversity can be addressed at these stages – including preclinical recommendations for prediction of pharmacokinetic or pharmacodynamic differences, inclusion of diverse participants in early development, engagement of diverse participants in study design considerations, epidemiological frameworks to guide appropriate diverse population enrollment targets, and data-driven methodological considerations for site selection, operational trial conduct, considerations for eligibility criteria and generalizability of endpoints.

Inaugural Meeting: 20th Annual Scientific Meeting, 21-23 February 2024, Washington DC – View slides

This group will address recent regulatory guidelines around diversity, equity and inclusion and the methodological challenges of patient population selection, enrichment, and generalizability.