Roundtable Discussion: Industry vs. Clinicians on Umbrella vs. Extended Trials
Time: 4:30 pm
day: Conference Day Two
Details:
- From an R&D and clinician standpoint, how can umbrella trials improve clinical efficiency without compromising the rigor needed for regulatory approval and payer confidence, especially when endpoints vary across CNS indications?
- What are the trade-offs between broad, parallel umbrella trial designs and the trend toward deep patient stratification using biomarkers for precision therapeutics?
- How do clinicians and trial sponsors navigate the real-world complexity of identifying, enrolling, and following narrowly defined CNS patient populations across multiple indications in a single umbrella trial?