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Dr. Satrajit Roychoudhury: Use of External Data in Clinical Trial: Unleashing The Power of Information
A Bayesian approach provides the formal framework to incorporate external information into the statistical analysis of a clinical trial. There is an intrinsic interest of leveraging all available information for an efficient design and analysis. This allows trials with smaller sample size or with unequal randomization. Examples include early phases drug development, occasionally in phase III trial, and special areas such as medical devices, orphan indications and extrapolation in pediatric studies. Recently, 21st Century Cure Act and PUDUFA VI encourage the use of relevant historical data for efficient design. An appropriate statistical method in this context needs to leverage “borrowing” of information while considering the heterogeneity between historical and current trial. In this short course, I’ll cover different statistical frameworks to incorporate trial external evidence with real life example.

Costs:
Developed country - € 80,-
Developing country / Students - € 40,-

AFTER THE REGISTRATION YOU'LL RECEIVE AN INVOICE FROM webinars@isi-web.org. WHEN YOU FINISH THE PAYMENT, YOU'LL BE GRANTED ACCESS TO THE ONLINE COURSE.
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