The Equity intention of the FDA is clear, the pharmaceutical industry must provide a Diversity Action Plan for all submissions—making trials more inclusive. This must be done through an evidence-based approach, providing a rationale for efficacy and safety to underrepresented populations, describing how the trials address inclusion, establishing goals for enrollment, operational tactics for enrollment and retention, and continuous monitoring to improve plans.
Although the FDA has been marching towards greater inclusivity in clinical trials, the guidelines do not provide standards of measurement for identifying progress.
To improve measurement across the industry, we need to implement an analytical framework tied to Social Determinants of Health and participant satisfaction. Regardless of the process methodologies we subscribe to, we need to embrace the intentions of Process Discovery, Analysis, and Optimization.
In this new webinar, a group of industry leaders share their thoughts on the measurements that the industry should align on, to establish Center Of Excellence standards for goals, benchmarks, and KPIs.
What you will learn:
- How to define and defend representation goals
- New ways to forecast participation growth rates
- How to define comparable benchmarks when validating targets
- How to devise KPIs for enrollment, retention, and optimization
- Ryan Brown, Global Head, Diversity in Clinical Trials, Science 37
- Ariel Katz, CEO, H1
- Mary Stutts, Global Chief Inclusion and Health Equity Officer, Real Chemistry
- Lorena Kuri, Head of Diversity Strategy, Bristol Myers Squibb