2017 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

Posted by Cytel

Oct 24, 2017 6:01:00 AM

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The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association. Each year 800 statistical practitioners come together to absorb new information on statistical practices in all areas regulated by the FDA.

Cytel was honored to be involved in the workshop program, and our subject matter experts added value to the conference by sharing their academic and regulatory experiences.

Don’t worry if you missed the event!

In this blog, we share the full slide set slide from Cytel contributions at the ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop.

Please click the button  below to access all the presentations.

Access Slides

Sample Size Re-Estimation: Controlling the Type-1 Error - Yannis Jemiai

Yannis Jemiai addresses uncertainty in trial design assumptions. He then analyzes one of the most popular adaptations, especially when using a promising zone approach. 

Bayesian Study Design to Leverage Informative Prior Information - Jim Bolognese and Sam Hsiao 

Two case studies are used to examine how to leverage informative prior information in study design.

Efficiency Promising of Zone Designs - Cyrus Mehta, Sam Hsiao and Lingyun Liu

With promising zone designs, efficiency is in the eye of the beholder.  Depending on the type of SSR rule adopted, an adaptive design may suffer a small power loss at the design stage.  But if the interim results are promising, then this will be more than compensated for at the interim monitoring stage.

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PS4b Parallell Session - Caroline Morgan

Shared DIA, FDA, and EMA perspectives on the uptake and application of adaptive designs across the industry.





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Topics: Clinical Data, Clinical Research Services, Adaptive Clinical Trials, adaptive designs, Sample Size, adaptive sample size re-estimation, Bayesian, Regulation, FDA, Promising Zone

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