Online Program Home
My Program

Abstract Details

Activity Number: 327 - Probabilistic Decision-Making in Clinical Research
Type: Topic Contributed
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #304385 Presentation
Title: Evidence Based Decision Making in Clinical Trials
Author(s): Erik Pulkstenis*
Companies: AbbVie
Keywords: decision making; evidence; bayesian

Decision making is a central part of drug development and a key driver of probability of success. Considerations relate to risk awareness and tolerance, and the quantifying and interpretation of pre-existing as well as generated evidence. Decisions like futility, GNG, or planned adaptation or early acceleration of a program have significant implications and as a result, the quality of the underlying decision-making process deserves careful consideration. P-value based decision making is becoming increasingly (appropriately) viewed as suboptimal, giving statisticians an opportunity to drive more suitable and conceptually meaningful methods to quantify evidence and support a decision-making framework. This talk will discuss various aspects of the target product profile (TPP) and its subsequent connection to both evidence generation and decision making. Comparison to traditional hypothesis testing-based strategies and associated operating characteristics will be provided.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2019 program