In the Interim…
In the Interim...
Podcast Description
A podcast on statistical science and clinical trials.
Explore the intricacies of Bayesian statistics and adaptive clinical trials. Uncover methods that push beyond conventional paradigms, ushering in data-driven insights that enhance trial outcomes while ensuring safety and efficacy. Join us as we dive into complex medical challenges and regulatory landscapes, offering innovative solutions tailored for pharma pioneers. Featuring expertise from industry leaders, each episode is crafted to provide clarity, foster debate, and challenge mainstream perspectives, ensuring you remain at the forefront of clinical trial excellence.
Podcast Insights
Content Themes
Explores Bayesian statistics, adaptive clinical trial designs, and innovative methodologies to tackle medical challenges, with episodes featuring in-depth discussions such as the transformative impact of platform trials during the COVID pandemic and regulatory navigation in adaptive trials.
A podcast on statistical science and clinical trials.
Explore the intricacies of Bayesian statistics and adaptive clinical trials. Uncover methods that push beyond conventional paradigms, ushering in data-driven insights that enhance trial outcomes while ensuring safety and efficacy. Join us as we dive into complex medical challenges and regulatory landscapes, offering innovative solutions tailored for pharma pioneers. Featuring expertise from industry leaders, each episode is crafted to provide clarity, foster debate, and challenge mainstream perspectives, ensuring you remain at the forefront of clinical trial excellence.
In this episode of “In the Interim…”, Scott Berry is joined by Jenny Devenport and Kaspar Rufibach of Merck Group, co-authors of the EFSPI Statistical Methodology Leaders paper “Statistical Methodology Groups in the Pharmaceutical Industry,” and May Mo of Amgen, a co-author of the commentary on the paper from the Statistical Innovation Community, an ASA Biopharmaceutical working group. The guests describe methodology groups within a pharmaceutical company as a strategic investment, and innovation as the product of invention and commercialization, where publication, regulatory dialogue, and validated software (“statistical engineering”) turn new methods into common practice. They discuss why new mechanisms of action and therapies such as CAR-T need more than a t-test or a log-rank test, and how estimands, causal inference, adaptive designs, and external data borrowing are reaching clinical trial statistics. The conversation addresses the concern that a dedicated group divides methodologists from project statisticians, how these groups demonstrate their value, why quantitative decision-making is a core competence of a pharmaceutical company, and why curiosity and collaboration matter as much as technical skill.
Key Highlights
- Innovation as the product of invention and commercialization, and the role of methodology groups in scaling new methods.
- New mechanisms of action, from delayed immune activation to CAR-T, that a t-test or log-rank test cannot handle.
- Estimands, causal inference, adaptive designs, and external data borrowing entering clinical trial statistics.
- Avoiding a divide between methodologists and project statisticians, and why there is “no unicorn statistician.”
- Showing value to leadership, from study involvement and due diligences to gains in probability of success.
- Quantitative decision-making: presenting design options with their risks, costs, and trade-offs.
- Curiosity, collaboration, and communication as the traits of an influential methodologist.
For more, visit us at https://www.berryconsultants.com/
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