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The FDA have finalised their guideline on 'Adaptive Designs for Drugs and Biologics'. Lots of sensible practical recommendations! https://www.fda.gov/media/78495/download
An updated draft of the FDA Guideline 'Adaptive Designs for Clinical Trials of Drugs and Biologics' was issued in September 2018. This is a good document with several relevant Case Studies in an...
The CHMP Guideline on the investigation of subgroups in confirmatory clinical trials was published in draft form in September 2013. It has taken quite some time but we now have a final version -...
The regulatory and scientific community has recently published on a new way of thinking about making comparisons based on single-arm studies with a pre-established threshold for demonstrating...