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June 13, 2012

Adaptive Clinical Trials: A Partial Remedy for the Therapeutic Misconception?

Author Affiliations

Author Affiliations: Departments of Emergency Medicine and Neurology, University of Michigan, Ann Arbor (Dr Meurer); Department of Emergency Medicine, Harbor-UCLA Medical Center, Los Angeles, California (Dr Lewis); and Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston (Dr Berry).

JAMA. 2012;307(22):2377-2378. doi:10.1001/jama.2012.4174

There is a common “therapeutic misconception” among patients considering participation in clinical trials.1 Some trial participants and family members believe that the goal of a clinical trial is to improve their outcomes—a misperception often reinforced by media advertising of clinical research.2 Clinical trials have primarily scientific aims and rarely attempt to collectively improve the outcomes of their participants. The overarching goal of most clinical trials is to evaluate the effect of a treatment on disease outcomes.3 Comparisons are usually made with placebo for conditions having no established treatments and with standard care for conditions having effective treatments. Any benefit to an individual trial participant is a chance effect of randomization and the true, but unknown, relative effects of the treatments. Available evidence is conflicting regarding whether patients receive some benefit from simply participating in a clinical trial.3 Thus, even though serving as a research participant is essentially an altruistic activity, many clinical trial volunteers do not participate in research out of altruism.4 An adaptive clinical trial design can be used to increase the likelihood that study participants will benefit by being in a clinical trial.