Phase 2b/3 interim analysis and "adaptive design"
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Posted On: 07/09/2020 3:46:15 PM
Re: reallypeople? #41861
Phase 2b/3 interim analysis and "adaptive design"
I understand the frustration and suggest this may be a gap in communication. The trial definition from the FDA trial site: "Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study"
Note the adaptive design for clinical trials is a guideline framework for adapting a trial based on one or more aspects of the data from the trial. It is possible the change in size was part of this process, and may be aimed at meeting an overall end point sooner. The smaller sample size may have presented a statistical challenge to actually making an adaption based on interim data. You can get more information on the process from the guideline itself.
https://www.fda.gov/media/78495/download
I understand the frustration and suggest this may be a gap in communication. The trial definition from the FDA trial site: "Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study"
Note the adaptive design for clinical trials is a guideline framework for adapting a trial based on one or more aspects of the data from the trial. It is possible the change in size was part of this process, and may be aimed at meeting an overall end point sooner. The smaller sample size may have presented a statistical challenge to actually making an adaption based on interim data. You can get more information on the process from the guideline itself.
https://www.fda.gov/media/78495/download
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