Episode 40, “Jumping Hurdles: Interim Analyses for Funding Decisions”
On Episode 40 of “In the Interim…” Dr. Scott Berry tackles a critical barrier in adaptive trial design: funding decisions.
When sponsors can't fund complete Phase II/III programs upfront, traditional designs force them to unblind Phase II data to secure investment. Scott presents an example in which a seamless design can save 20+ months and 60+ patients but the challenge is getting funding.
The solution to this is administrative analyses with objective funding triggers. Using predictive probability of success, sponsors can demonstrate proof of concept to funders without unblinding trial data or risking operational bias, tapping into the huge savings in patients and time.
Listen as Scott breaks down seamless Phase II/III designs, regulatory considerations, and practical strategies for turning funding barriers into efficient trial pathways.
https://www.berryconsultants.com/resource/40-jumping-hurdles-interim-analyses-for-funding-decisions