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Activity Number: 172 - Quantitative Decision Making in Clinical Trials
Type: Contributed
Date/Time: Monday, July 29, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #304548 Presentation
Title: In Silico Clinical Trials : a Way to Improve Clinical Development?
Author(s): Nicolas SAVY* and Philippe SAINT-PIERRE and Stephanie SAVY and Emmanuel PHAM
Companies: Toulouse Institute of Mathematics and Toulouse Institute of Mathematics and ESTRIALS and IPSEN Innovation SAS
Keywords: Clinical trials; Simulation; Methodology; Agent-based model

Many clinical trials are negative or inconclusive. Thomas Burns (Clinical Development Success Rates 2006-2015, 2016) estimates to 42 % the proportion of Phase III trials which fails to meet the primary objective. The causes of such failure are numerous. Obviously, there is the lack of effect of the treatment under study, a cause which cannot be anticipated. But there are other causes related to trial design and trial operation that can be avoided or at least tested by means of simulation studies. The aim of In Silico Clinial Trials (ISCT) is to test the feasibility of an experimental design and to evaluate its sensitivity to a modification of the design parameters. By this way, one can optimize the trial design by anticipate what can happen during the trial. The purpose of this presentation is to outline what an ISCT may be and to focus on the methodological pillars of this approach (clarity / parsimony / completeness). Issues on the development of ISCT will also be discussed.

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

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