Adaptive and Flexible Clinical Trials by Richard Chin

By Richard Chin

Adaptive medical trial designs, not like conventional mounted scientific trial designs, let amendment of stories in keeping with the information generated throughout the trial. This usually ends up in reports which are considerably quicker, extra effective, and extra strong. contemporary advancements in web-based real-time information access and advances in statistical equipment have made adaptive medical trials even more popular Read more...

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All of these can affect the generalizability of the study, but because they affect both control and treated arms equally, they do not usually affect the ability to draw conclusions regarding the differences between the arms (internal validity). Differential bias affects arms of a study unequally and does represent a threat to internal validity of a study because such biases affect the apparent efficacy of the treatment. One important differential bias is differences in baseline characteristics.

Adaptive designs can be powerful, but the statistical techniques are still in the process of being developed. The demands being placed on conventional statistical techniques are straining the conventional frequentist statistical methods to the breaking point. Currently, this strain is being manifested as debate about the validity and integrity of adaptive techniques. Validity and integrity are sometimes defined differently but as mentioned before, internal validity means that the conclusions from a study represent the truth; external validity means that the results of a trial can be extrapolated to the broader patient population as a whole, and integrity means that the blind and other statistical formalities have been properly maintained.

FDA’s review focus in later stages of drug development continues to include safety of study subjects, but also includes assuring that studies performed at this stage contain plans for assessment of safety and efficacy that will result in data of sufficient quality and quantity to inform a regulatory decision. , the End-of-Phase 2 (EOP2) meeting and Special Protocol Assessments (SPA)). Depending on the preexisting breadth and depth of information regarding the drug, its specific use, and the nature of the adaptive features, an EOP2 meeting may be the appropriate place in development for initial discussion of an adaptive design A&WC study.

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