Diversity in CNS Clinical Trials
Chairs: Abhishek Pratap, PhD; Siân Ratcliffe, PhD
Upcoming Activity: Working Group Meeting, 21st Annual Scientific Meeting, 19-21 February 2025, Washington DC
Looking ahead to the 2025 Annual Meeting in DC, we’re eager to build on our previous discussions to help generate robust and generalizable evidence —from early-stage discovery all the way through to late-stage evidence generation in Phase III and post-market studies.
We’ll be diving into important topics, including addressing potential biases in preclinical data, ensuring diverse participants are included in the early stages of development, and engaging a variety of voices in study design. We’ll also explore helpful frameworks to guide population
enrollment and share innovative methods for selecting study sites, conducting trials, and determining eligibility criteria so that our endpoints can be more relevant to everyone.
The group will also discuss a potential to run a “Diversity in CNS trial session” in one of the upcoming main ISCTM conferences.
Together, we can strengthen the foundation for more inclusive and effective clinical trials that truly reflect the diversity of the populations they aim to serve.
Most Recent Deliverable: Comment on FDA Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry
Most Recent Activity: Working Group Meeting, 2024 Autumn Conference, 12-13 September 2024, San Diego, CA – View slides
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.