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Adapting To A New Kind Of Trial

Monday, July 17, 2006

It’s great to see the FDA making a move this week to develop guidelines for adaptive clinical trials. Their time has come, given recent advances in scientific tools, such as toxicogenomic assays.

Of course, purists will argue that changing a trial midway through a study somehow benefits pharmaceutical companies by potentially allowing them to manipulate results. Some worry that bias is more likely when results are known during the trial, compared with keeping trials blind…

Adaptive trials are already here in early-phase studies, so the FDA needs to produce new guidelines. The promise for these trials is just too big to dismiss. One of the biggest bottlenecks for completing trials is finding volunteers to participate, we find, and adaptive trials could cut the number of patients needed for trials by a third. In an adaptive trial, it is possible to adjust the sample size. That would result in significant savings for drug companies and bring promising drugs to patients sooner.

In addition to cost savings, the FDA believes adaptive trials can offer significant ethical advantages. Scott Gottlieb, MD, the FDA’s deputy commissioner for Medical & Scientific Affairs, said adaptive trials have already become relevant in AIDS clinical trials, where interim analysis of trials have been common, compared with classical randomized studies that may pose ethical dilemmas.

Patient safety could also be improved by using adaptive trials. By identifying patients who absolutely cannot tolerate the drug, it can be made clear at the outset which patients cannot take it, thereby avoiding a costly drug withdrawal if some patients have serious adverse effects.

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