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By Richard Chin

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

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For example, perhaps the study was under­ powered, did not test a high enough dose, or was terminated too early. It may also be due to poor quality data, because of missing data, patient dropouts, or unreliable measurements. It may also be due to failure to minimize bias, such that the results are not reliable. Unfortunately, one of the most common causes for uninterpretable results is poor study design. In order for a study to render valid conclusions, it must be free of bias. Bias is an error that changes the result of a study in a spurious manner.

5. New flexible designs that allow modification of study designs after the interim unblinded analysis may or may not be valid and FDA will view them cautiously. However, they do not rule out the potential for utilizing such designs, especially in circumstances where other designs may not be sufficient. Dose-finding adaptive designs may in some special circumstances be appropriate for pivotal studies, although FDA sees more of a role for them in Phase II studies. The FDA regards adaptive randomization with some caution, particularly in cases where it may result in an imbalance in patient characteristics among the groups as this can introduce a bias, but may be open to it if used carefully.

This is largely because they allow better calibration of study parameters such as sample size to reality, and rely less on assumptions, It is important that the question have construct validity. For instance, if the purpose of the study is to determine whether a thrombolytic drug has a beneficial effect on myocardial infarction patients, including the incidence of re-ischemia and congestive heart failure without including death as part of a composite endpoint might lead to inappropriate conclusions.

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