Webinar Replay: Phase 2 Trial Designs using Program-level Simulations

Posted by Cytel

Oct 18, 2017 11:03:00 AM

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Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches helping to bridge the gap from methodology to implementation. Ultimately, our goal is to enable our audience to improve their chances of success in clinical development.

The series got underway in August with a webinar on ‘Phase 2 Trial Designs using Program-level Simulations, and Possible Adaptive Approaches’.

Jim Bolognese, Cytel and Narinder Nangia, Alkermes revealed how Phase 2 sample size can be optimised to yield maximum eNPV when 1 or 2 doses could be selected for Phase 3. They then analyzed the study of more doses adaptively in Phase 2 toward to improve Probability of Success and increased eNPV (unless AE rates low for all doses).   

The presentation summarized the extension of Patel et al. (2012) to design Phase 2 trials based on program-level optimization (i.e., optimizing the entire Phase 2/3 drug development strategy).

Missed the Webinar, but interested in learning more?

In this blog, we offer you the opportunity to enter your details to watch the replay of the presentation and access the slide deck, simply click below.

Webinar Replay 

Don’t miss the next webinar in the series

Tomorrow: Thursday, October 19th, 2017, 11:00am – 12:00PM (EDT)

Formal Go/No-Go decisions are a key component of risk management in early clinical development.

Presented by Pat Mitchell, Statistical Science Director at AstraZeneca

Our October webinar will again examine impact of applying innovative statistical methods – in this case, defining prospective decision criteria within the trial design - to better inform verdicts on a program's fate.

Registration is required to join this event. If you have not registered, please do so now. 

REGISTER

Further reading

Simulations to optimise clinical trial programs

White paper on adaptive clinical trials 

 

Topics: Trial Design, Program and Portfolio Optimization, Adaptive Clinical Trials, phase 2, Simulations

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