“Adaptive Clinical Trial Design: Large-Scale Study Simulation to Design for Results with Boaz Adler

Transformation in Trials

This week we speak to Boaz Adler from Cytel's Software Division. This episode promises to illuminate the intricacies of trial design through the lens of Monte Carlo simulation, revealing how this potent approach crafts trials resilient to a myriad of scenarios. Boaz delves into the pivotal roles of interim monitoring and strategic market positioning post-trial, offering a masterclass in the art of clinical trial conception that withstands the test of uncertainty.
As we navigate the vast landscape of clinical trial simulation, the topic of scale takes center stage. The conversation orbits around pioneering software platforms like Solara and East, which are reshaping trial design by integrating a kaleidoscope of variables and uncertainties. This episode pulls back the curtain on the potential of cloud computing to revolutionize simulations, providing a glimpse into the future where clinical trials are executed with unparalleled speed and precision. With Boaz' expertise, we ponder the industry's readiness to trust probabilistic outcomes and how regulatory bodies are warming up to the simulation-based approaches that these software platforms enable.
Finally, we bridge the gap between biostatistics and market access, highlighting the increasing influence of health outcomes research on clinical trial design. The discourse delves into the balancing act of incorporating quality of life measures for regulatory and reimbursement decisions, the finesse required to blend standard software with bespoke coding, and the imperative of enhanced inter-departmental synergy. My own path to life sciences underscores the episode's reflective tone, leading to a broader examination of Cytel's extensive contributions to the field, from their roots in Monte Carlo simulation software to a comprehensive suite of services that spans the full spectrum of statistical programming and evidence-based research. Join us for this enlightening episode to gain an insider's perspective on the dynamic confluence of biostatistics and pharmaceutical innovation.
Guest:
Boaz Adler

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Hoofdstukken

1. “Adaptive Clinical Trial Design: Large-Scale Study Simulation to Design for Results with Boaz Adler (00:00:00)

2. Simulation for Designing Clinical Trials (00:00:13)

3. Clinical Trial Design With Scale (00:09:31)

4. Market Access and Biostatistics in Trials (00:21:05)

5. Disease and Misunderstandings in Life Sciences (00:27:51)