CASE STUDY
Diversity & inclusion in clinical trials – Driving change
Our collaboration brought together leaders from across disciplines to identify barriers and develop a roadmap to foster greater diversity, participation, and inclusion in clinical trials.
CLIENT
American Society of Hematology
CHALLENGES
What are the barriers to diversity & inclusion for clinical trials in rare hematologic diseases and how do we address them?
How do we leverage the global convening power of ASH to mobilize leaders across disciplines and drive change?
Project insights
Real World Burden
The logistics associated with trial participation and decentralized infrastructure for community engagement are key barriers to diverse and inclusive trials.
A Common Language
The lack of a common global language regarding diversity demographics and definitions that inform standards for inclusivity, and restrictive eligibility criteria hinder trial enrollment of minoritized individuals.
“Just Ask Us”
To address barriers to participant recruitment and retention, clinical trial sponsors must pro-actively engage communities and patients during trial design.
Building Trust
Efforts to address health literacy and understanding around clinical trial participation, as well as strategies to build relationships with participant populations and their communities are critical to driving change.
Our impact
Issues and barriers to more diverse clinical trials were identified via focus groups with constituents from across disciplines including patient advocates, government agencies, CROs and AROs, academia, and industry.
A Clinical Trial DE&I Toolkit was developed incorporating actionable steps for trial design consideration, reference articles, and additional resources from both national and international regulatory bodies and research organizations. The toolkit serves as a resource guide to help sponsors implement DE&I principles throughout the clinical trial life cycle (from formulating the research question to execution and dissemination of trial results).
A roadmap to improve diversity and inclusion in clinical trials will be generated providing a way forward and empowering sponsors, investigators, trial operators, regulators, government agencies, providers, and communities to work together.