Panel: Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?
With combined experience running studies and drafting FDA rules, this panel will show why guidance on trial diversity has not produced results. Audience polling will help illuminate how incentives can translate guidance into thoughtful action.
- Nick Kenny
Panel: Using Real-World Data in Single-Arm Trials: When It’s Done, Why It’s Done, How It’s Done
As real-world data increasingly provide synthetic controls in single-arm drug registration studies, terminology and insights have evolved. The structured, multistep assessment process described addresses why, when, and where to use new approaches.
Learn fundamentals of synthetic control arms & RWD integration into clinical trials; understand relevant key terminology; evaluate feasibility of using an external control arm in a clinical trial; weigh pros and cons of historical vs concurrent control arm data; identify potential external sources for control populations.
- David Thompson