Abstract #302249

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JSM 2003 Abstract #302249
Activity Number: 57
Type: Contributed
Date/Time: Sunday, August 3, 2003 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #302249
Title: Risk Assessment Modeling of a Clinical Trial Program with Multiple Endpoints and Replication Studies
Author(s): Daniel Z. Wang*+
Companies: Johnson & Johnson Pharmaceutical Research and Development, LLC
Address: 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560-1504,
Keywords: clinical trial ; risk assessment ; success probability
Abstract:

Risk assessment of later-phase trials is an important part of the drug development process. Choices of strategies for an optimal late-phase program, resource planning, and business forecasting all depend on risk assessment. One major element of the risk assessment is to estimate the success probability of a later phase clinical trial program. Often, there are more than one replication studies and each study has perhaps more than one primary efficacy endpoints as the success criteria. In such cases, making sensible assumptions, and arrive somewhat reliable estimation of the overall success probability of the entire late phase clinical program become a nontrivial task. In this paper, we explore the modeling and simulation method to estimate the overall success probability of a phase III program where two pivotal studies have more than two coprimary endpoints. It is shown that existing method of assuming independence of studies and endpoints gives an unreliable prediction. While parametric modeling the dependence of the endpoints resulted in a more realistic prediction of the overall success probability. Using Bayesian approach, clinician's opinion can also be incorporated.

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