The International Society for Biopharmaceutical Statistics (ISBS) reposted this
Dear Fellow Statisticians, We are pleased to announce an exciting seminar on clinical trial innovation as part of the ISBS Webinar Series. The seminar, titled "A Quantitative Approach to Maximize Return on Investment in Oncology Drug Development" will be held on February 7, 2025, 11am-12pm EST, featuring distinguished speaker Dr. Cong Chen from Merck. Abstract: The IO revolution in the past decade is unprecedented in the history of oncology drug development. The high success rate of PD-(L)1 immune checkpoint inhibitors has encouraged an aggressive approach to developing these agents. However, applying the same strategy to other agents has yielded limited success. As the standard of care improves, most novel therapies under development are unlikely to achieve similar success. A more balanced approach is required. A benefit-cost ratio (BCR) analysis method, originally developed in a similar environment before the IO revolution, is reintroduced to offer current oncology drug developers a fresh perspective. It shows that, while prior data on drug activity is crucial for determining the aggressiveness of a Phase 2/3 program (e.g., Phase 2, adaptive Phase 2/3, or Phase 3), once the program is launched, it becomes less important than the relative cost savings in deciding whether to continue. It is often unknown whether a drug has the target treatment effect, but projecting costs is easier, allowing for the creation of robust baseline decision rules based on BCR analysis. While Type I and II errors are often a focus at the trial level, Type III error is a concern at the portfolio level. Properly balancing all three is key to long-term success, which can be similarly achieved with BCR analysis. Registration Details: Please register using the following link: https://lnkd.in/eu-AYzJx We look forward to your participation on February 7!