White Paper

A View From The Clinical Floor

By Jay Umbreit, M.D., independent consultant and oncology physician advisor, Catalyst Clinical Research

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Adaptive trials can mean a variety of things -- a change in the trial parameters or in the design of an ongoing trial based on acquired data. Some adaptations are easy to implement maintaining statistical validity while others are more difficult, questioning statistical strength. The type of statistics being used for the analysis of the trial also plays a factor (1).

From the viewpoint of the clinician, some care is required in interpreting the results, especially the strength of statistical inference. But adaptive designs allow more flexibility and control over the trial and, hopefully, will lead to defining the optimal strategy for the given therapy. Bayesian statistics is likely to dominate the future standard of trial design but does involve change in how clinicians interpret the results.

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