Simulations Help Optimize Trial Design

Date: 01 May 2014  |  Topic: Biostatistics
Jurgen Hummel

Jürgen Hummel

Statistical Science Director, Biostatistics

Clinical trial simulations can provide insight and help guide the design of a clinical trial, particularly in complex situations with multiple interacting parameters. There is typically no “best” design; instead the goal is to identify a design that has a high probability of success under the most likely conditions but also performs well (or at least acceptably) under more extreme conditions.

A quick look at simulations:

  • Clinical trial simulations can predict study results and guide the selection of design parameters.

  • Clinical trial simulations are most powerful when using specialized software. PPD employs the Fixed and Adaptive Clinical Trial Simulator (FACTSTM), an industry-leading platform that is particularly powerful when simulating early stage (usually Phase I and Phase II) trials.

  • The U.S. Food and Drug Administration (FDA) endorsed clinical trial simulations, stating that the results “could reduce the risk and cost of human testing by helping product sponsors make more informed decisions on how to proceed with product testing and when to remove a product from further development.”

  • Simulations are particularly well-suited for adaptive trials where operating characteristics make clinical trial simulations an invaluable tool for effec­tively – and efficiently – choosing the adaptive elements and optimizing the overall design.

  • Adaptive designs and clinical trial simulations help make the best use of available resources by increasing the sponsor’s confidence that a specific study will answer the question it was designed to address.

Trials designed using these approaches are not automatically smaller, shorter or less expensive than non-simulated trials. These single-study benefits, however, can cascade through the entire development program by greatly reducing the chance of inconclusive studies and identifying potential gaps in the program earlier in the process.

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