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One of the most talked-about cancer clinical trials last spring was BATTLE — a phase II trial that did not change practice or introduce a new drug. What got all the attention was the non-small cell lung cancer trial’s “adaptive” design. In adaptive trials, data gathered as the trial progresses are used to change some aspect of the trial midstream. These trials have increased over the past decade, a trend fueled by the need to improve the poor success rate of conventional clinical trials and one that the U.S. Food and Drug Administration supports. The adaptations can be to drop a treatment arm that isn’t effective, alter dose levels, or increase the trial size if a drug proves less

Adaptive Clinical Trial Design: Has Its Time Come?