Adaptive Clinical Trials: Elements, Myths and Tips

Author: Mukesh Kumar
Adaptive Clinical Trials are trials that adapt to changes measured “within” the trial or change in major aspects of the study, mid-study, that could impact the outcome. Adaptive design clinical can be defined as a study that includes a prospectively planned opportunity for modification of the study design and hypotheses based on analysis of data. Analyses of data are performed at prospectively planned time points in a fully blinded or in an unblended manner.
1. Elements of an Adaptive Clinical Trial
Adaptive Clinical Trial involves interim analysis of data generated in a study to modify/revise the study design (arms, duration of treatment) sample size (i.e., no of subjects), inclusion/exclusion criteria, randomization and statistical endpoints.
2. Uncommon Indications For Adaptive Clinical Trials
Some of the uncommon Indications for Adaptive Clinical Trials are: -Very long time for final response, very swift recruitment, and population changes expected over the duration of the trial.
3. Myths on Adaptive Clinical Trials
Adaptive Clinical Trials is not: preliminary shutting of a study for safety, ethical or financial reasons; revisions after unplanned findings in an interim analysis; revisions based on information from a study external source.
4. Tips to assess impact
Depending on what is modified, the impact will be different if the rules are not pre-specified, the entire trial may be hard to interpret. The results might be hard to support or adjust by pre-specified statistical methodology (retrospective analysis?). Statistically the results may be invalid.

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