Predictive Reasoning in Phase II-III Decision Making
View Presentation *Beat Neuenschwander, Novartis Pharmaceuticals Keywords: heterogeneity, induction, probability of succes, uncertainty Predictive thinking is an integral part of good decision making. However, predictions require plausible assumptions for extrapolating from the present to the future, the notoriously difficult problem of induction. Considerations of probability of success (PoS), or predictive power, comprise qualitative (e.g. choice of endpoint) and quantitative aspects. Well calibrated PoS calculations should include all relevant sources of uncertainty. These comprise sampling uncertainty, parameter uncertainty, as well as between-trial and between-endpoint heterogeneity (PFS vs. OS). The most informative phase II design is a randomized trial with the same endpoint as in phase III. If such a trial results in promising effect estimate and between-trial heterogeneity is small, PoS for phase III will be approximately 60 to 70%, but can be much smaller if endpoints in phase II and III differ (PFS vs. OS).
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC