Adaptive Dose-Finding Designs: Improving Drug Development Strategies
Thank you for your interest in the recording of our recent webinar with Cytel Strategic Consultant, James (Jim) Bolognese on dose-finding designs. In this webinar, Jim shares his considerable Phase 2 development experience. He reviews how a single adaptive dose-finding design can replace the traditional sequence of 2 separate non-adaptive trials (PoC high-dose vs. placebo trial followed by a dose-finding trial).
Topic and speaker resources:
- Read research paper Simulations for optimizing clinical trial programs published by Bolognese and colleagues at Cytel
- Recent FDA News briefing on adaptive trials
- More on Jim and the Cytel Strategic Consulting team members
James (Jim) Bolognese, Cytel Strategic Consulting Statistician
Jim Bolognese has over 40 years experience as a life sciences biostatistician. After 33 years with Merck and now with Cytel, Jim assists clients with the design of clinical research programs and clinical trials, including adaptive design and implementation. Jim provides statistical support of experimental medicine, proof-of-concept studies, biomarker development, as well as methodological and technical guidance for clinical pharmacology, late phase, and outcomes trials. He’s experienced at building, testing and refining statistical software. Together with collaborators from industry and academia, Jim’s biostatistical research has been published in peer-reviewed journals including Statistics in Medicine, The Drug Information Journal, and PAIN. Jim earned his Master of Statistics from the University of Florida after receiving a BS in Math from Bucknell.