Adaptive Designs in Clinical Trials

ABSTRACT

The traditional clinical trial is a rigid channel of drug development process. After successful Phase 1 trials and Phase 2 trial with sufficient efficacy and safety, the drugs goes into Phase 3 trials, where it is compared with a placebo or standard treatment (control). Performing this for each new drug separately need more manpower (patients/participant), money (financial resources), and time. On November 2019, the Food and Drug Administration issued a final guidance for the industries entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics.” They defined adaptive design as “a clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial.” In simple words, adaptive design means a design that permits modifications of “the trial procedures and/or statistical procedures of the trial” after its beginning without compromising the validity and the integrity of a trial. There are nine types of adaptive designs that includes adaptive randomization design, group sequential design, sample size re-estimation design, drop-the-losers design, adaptive dose finding design, adaptive treatment-switching design, biomarker-adaptive design, adaptive-hypotheses design, and adaptive seamless Phase II/III designs which has been explained in detail, in this review article. Although the concept of adaptive design has been there from long before but one of the major disadvantages it faces is the lack of uniformity.

KEYWORDS

• Adaptive designs
• biomarker-adaptive design
• sample size re-estimation design
• seamless phase II/III design
• sequential designs

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• DOI10.4103/jpp.JPP_79_20Copy