Get Adaptive and Flexible Clinical Trials PDF

By Richard Chin

ISBN-10: 143983833X

ISBN-13: 9781439838334

Adaptive scientific trial designs, not like conventional mounted medical trial designs, permit amendment of reviews in line with the knowledge generated throughout the trial. This frequently leads to experiences which are considerably quicker, extra effective, and extra robust. contemporary 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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Non-pivotal studies (studies that are not intended to be “adequate and well controlled” [A&WC studies]) may use adaptive design freely. The FDA is much more concerned about validity of adaptive designs for A&WC studies. Traditional adaptive designs that clearly preserve the alpha, such as group sequential designs, pose no regulatory problems. Adaptive designs that rely on blinded data, such as variance or other “nuisance” parameters pose, no regulatory problems. This is the case even if the blinded data lead to changes in the primary endpoint or the analytic method for the primary endpoint.

The various designs are fully explored in detail later in the book but briefly summarized here. The simplest studies are individual sequential designs, also known as fully sequential designs. These studies incorporate analysis of data Background 21 after each patient or each data point, and adapt the next dose or patient treatment accordingly. Group sequential designs are designs that incorporate one or more interim analysis and can lead to termination of one or more arms of the study. Modern true adaptive designs incorporate multiple analyses, sometimes on a continual basis, and can lead to changes in almost any design parameter.

Collecting and characterizing as much information as possible about the dose response, toxicity curve, subgroups’ difference in response and adverse events, PK/PD characteristics, and other factors all improve the likelihood of success in the confirmatory studies if the information is utilized effectively. And, as he rightly points out, clinicians who will be using the drug also often need that information. Simply knowing that a drug works is insufficient to maximize the utility of the drug after approval.

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Adaptive and Flexible Clinical Trials by Richard Chin


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