|
Activity Number:
|
537
|
|
Type:
|
Invited
|
|
Date/Time:
|
Thursday, August 6, 2009 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #302893 |
|
Title:
|
A Model-Based Framework for Quantitative Decisionmaking in Drug Development
|
|
Author(s):
|
Kenneth G. Kowalski*+ and Jonathan L. French and Mike K. Smith and Matthew M. Hutmacher
|
|
Companies:
|
Ann Arbor Pharmacometrics Group and Pfizer Inc. and Pfizer Inc. and Ann Arbor Pharmacometrics Group
|
|
Address:
|
(A2PG), 110 Miller Ave, Ann Arbor, MI, 48104,
|
|
Keywords:
|
modeling ; clinical trial simulations ; decision-making
|
|
Abstract:
|
This talk proposes a general framework for the formal integration of model-based predictions and their uncertainty in the planning of prospective trials and quantitative decision-making. Standard operating characteristics such as power, which are conditional on a chosen effect size, quantify the performance of the design. Optimizing trials based solely on power does not fully address the needs of drug development teams interested in understanding the performance of the compound as well as the performance of the proposed study design. This is because power is a conditional probability which does not quantify how likely the compound can achieve the assumed treatment effect. Trial performance metrics such as probability of a correct decision, probability of a Go decision, and probability of technical success are proposed to evaluate the performance of the compound in the proposed trial.
|
