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June 13, 2012

Adaptive Trials in Clinical Research: Scientific and Ethical Issues to Consider

Author Affiliations

Author Affiliations: University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, the Netherlands.

JAMA. 2012;307(22):2379-2380. doi:10.1001/jama.2012.6380

Interest in the use of adaptive trial design has increased among clinical investigators, pharmaceutical companies, and regulatory authorities. Adaptive trials are randomized clinical trials that allow for adaptations in the study design while the study is being conducted. Modifications as a study is being conducted can include changes in sample size, adjustments in medication dosage, or changes in the number of treatment groups. Adaptive trials can often decrease drug development time, which can have clinical and economic advantages.