Abstract:

The aim of this review is to explore the learning outcome and understanding how the adaptive study design helps in current scenario of drug development in various therapeutic areas compared to traditional randomized clinical trials with respect to Dose Finding, identification of Maximum tolerated dose (MTD), fewer subjects, short duration, increases success rate of study objective, yields better knowledge of treatment effect like better estimates of sub-group effects or dose-response relationship. One of the major advantage of this study design is that potential changes are approved prior hand by regulatory authorities and ethics committee, hence there is no need to submit the protocol amendment and also logistics for the change in treatment is also planned upfront and researchers are given full flexibility to respond towards unexpected events and there are several options proposed upfront to introduce any new doses, amend endpoints. The conclusion is that the use of Adaptive designs appears to be increasing in certain diseases and in some of the diseases it is still underutilised. FDA and other regulators, researchers are still exploring how and the extent to which they may be incorporated into the evaluation of experimental therapies bearing in mind that focus will be mainly in feasibility, validity, flexibility, integrity and efficiency. As the new regulatory guideline are already established, future investigations of adaptive designs could examine ongoing dynamics in trials and based on this project, there are some suggestions to be given to the researchers to include the adaptive design or methodology to be indicated in the study title which certainly helps to retrieve the data easily.

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