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Updated: Aug 18, 2026

Efficient Sampling of Genetically Encoded Biosensor Design Space Enabled with a Design of Experiments and Automation Workflow
Published on: October 17, 2025
Biostatistical methods for demonstrating efficacy in the regulatory setting. An epistemological approach to adaptive
1Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn. a.koch@bfarm.de
Abstract:
Adaptive designs are one of the most promising developments in statistics with applications to clinical trials. Obviously the knowledge at the beginning of a clinical trial will always be limited. In consequence it may be considered necessary that the knowledge from accumulating information should be used to optimize the design of the trial. This paper discusses conditions under which this may be possible in phase III clinical trials where the principle aim is confirmation of hypotheses that have been developed in earlier stages of drug development.
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