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What Is The Adaptation Process In Clinical Design

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Adaptive Design Clinical Trial: FDA definition: “a study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study.” A medical device or treatment by observing participant outcomes (and possibly other measures, such as side-effects) on a prescribed schedule, and modifying parameters of the trial protocol are the parameters that used in the evaluation of the adaptive clinical trials. The adaptation process generally continues throughout the trial, as prescribed in the trial protocol. In some cases, trials have become an ongoing process that regularly adds and drops treatments and patient…show more content…
Adaptive Randomization design: The main concept in this design is the modification of randomization schedules based on varied and unequal probabilities of treatment assignment. The purpose is to increase the probability of success. It is well known that the adaptive randomization design could increase the probability of success (so-called play-the-winner), but it may not be applicable for a large trial or a trial that requires long treatment duration because the randomization of a given subject depends on the response of the previous subject Group sequential design: A group sequential design is a design that allows for prematurely stopping a trial due to safety concern or efficacy or both with options of additional adaptations based on results of interim analysis Sample size re-estimation design: It is the type of the adaptive design that allow for sample size adjustment or re-estimation based on the observed data. Sample size adjustment could be done in either a blinding or unbinding fashion based on some factors. The most important factors are the criteria of treatment effect-size, the power, and the probability of reproducibility.
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