Hoping to make clinical trials more efficient, pharmaceutical companies have begun embracing more flexible trials that evolve based on the data they generate. In recognition of this trend, the US Food and Drug Administration (FDA) has begun drawing up a series of guidance documents for such trials. But these so-called adaptive trials also have drawn criticism that their results are more difficult to interpret and more vulnerable to unblinding and bias.
The principle difference between adaptive clinical trial designs and traditional designs is that the data in adaptive trials are analyzed on an interim basis and used to dictate the future course of the trial, said Donald Berry, PhD, chair of the department of biostatistics and applied mathematics at the M. D. Anderson Cancer Center in Houston.
Kuehn BM. Industry, FDA Warm to “Adaptive” Trials. JAMA. 2006;296(16):1955-1957. doi:10.1001/jama.296.16.1955