This guideline will be of interest to many of my colleagues. The first section is both "Introduction and Scope" and is interesting as much for what is in scope as what is excluded and limiting to the covered Scope:
"This document provides guidance on confirmatory clinical trials with an adaptive design intended to evaluate a treatment for a given medical condition within the context of its overall development program. For the purpose of this guideline, an adaptive design is defined as a clinical trial design that allows for prospectively planned modifications to one or more aspects of the trial based on interim analysis of accumulating data from participants in the trial. The term prospectively planned means that the potential trial adaptations are pre-specified in the clinical trial protocol prior to initiation of the trial. The scope of this guideline does not include trials with unplanned modifications to the design, such as a protocol amendment proposed by an independent data monitoring committee (IDMC) based on unexpected interim results. It also does not include design changes based entirely on emerging information from a source external to the trial. Routine monitoring of operational aspects such as the enrollment rate, data quality, or extent of participant withdrawal is also out of scope."
After discussing Key Principles (i.e., those topics that must be thoroughly considered and planned for, the guideline discusses several "types of Adaptations", before going on to consider Simulation studies, Bayesian Methods, Time-To-Event settings, and Exploratory trials, and ending with a section on Documentation needed both before starting an adaptive trial and that to include in a filing.
#ICH #E20 #AdaptiveDesignClinicalTrials
A link to a Word version of the file is available here: https://www.ich.org/page/efficacy-guidelines#19-1
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/------------------------------