About This Webinar
Join Bioforum and CCS for a practical discussion on adaptive and Bayesian trial designs and the endpoint choices that can make or break cardiovascular studies. We’ll cover key tradeoffs, common pitfalls, and lessons learned across time-to-event, event-count, composite endpoints, and win ratio, followed by live Q&A.
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Agenda
- Practical pros and cons of adaptive and Bayesian approaches in cardiovascular trials
- Common adaptive designs sponsors use most often (sample size re-estimation, seamless Phase 2/3, adaptive enrichment)
- Endpoint strategy decisions that impact interpretability: time-to-event vs event-count, composite and dual endpoints
- Win ratio in CV trials: when it adds value and key caveats to plan for
Featured Presenters
Zoran Antonijevic, Bioforum
Chief Scientific Officer, Bioforum The Data Masters
Zoran held executive positions in Pharmaceutical Companies and CROs and designed well over 100 clinical trials in numerous therapeutic areas, many of which included innovative designs. Zoran was a long-time Chair and leader of the DIA Innovative Design Scientific Working Group. He has authored numerous papers, scientific presentations, courses and trainings, and was editor of books “Optimization of Pharmaceutical R&D Programs and Portfolios” and, together with Bob Beckman, “Platform Trials in Drug Development”.
Marvin A. Konstam, MD
Chief Scientific Officer, Cardiovascular Clinical Science
Professor of Medicine and Radiology, Tufts University School of Medicine.
Marvin A. Konstam, MD, is an internationally recognized leader in heart failure research and cardiovascular drug and device development. As the Founder and Chief Scientific Officer of Cardiovascular Clinical Sciences (CCS), established in 1997, he has guided companies and investigators through every stage of clinical research, drawing on more than 30 years of experience integrating scientific rigor with regulatory expectations.
Dr. Konstam also served as Chief Physician Executive of the Cardiovascular Center at Tufts Medical Center and is Professor of Medicine and Radiology at Tufts University School of Medicine. Marv has led major heart failure programs and advanced clinical innovation for decades. A graduate of Columbia University with further training at Massachusetts General Hospital, Brigham and Women’s Hospital, and Harvard Medical School, he has played central roles in pioneering research on ventricular remodeling and in numerous cardiovascular clinical trials, including work shaping statistical and methodological approaches to evaluating therapies. His long-standing regulatory involvement includes service on the FDA’s Cardiovascular and Renal Advisory Panel and advisory work with CMS on evidence development and heart‑failure quality‑of‑care initiatives.
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