Adaptive design (medicine)

In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis.^[2][1][3] Adaptive design typically involves advanced statistics to interpret a clinical trial endpoint.^[1] This is in contrast to traditional single-arm (i.e. non-randomized) clinical trials or randomized clinical trials (RCTs) that are static in their protocol and do not modify any parameters until the trial is completed. The adaptation process takes place at certain points in the trial, prescribed in the trial protocol. Importantly, this trial protocol is set before the trial begins with the adaptation schedule and processes specified. Adaptions may include modifications to: dosage, sample size, drug undergoing trial, patient selection criteria and/or "cocktail" mix.^[4][5] The PANDA (A Practical Adaptive & Novel Designs and Analysis toolkit) provides not only a summary of different adaptive designs, but also comprehensive information on adaptive design planning, conduct, analysis and reporting.^[6]