FDA open to adaptive clinical trials

The US Food and Drug Administration has presented plans to develop regulatory guidelines for adaptive trials, which contradict the blind clinical trial approach.

Michael Kyams, recently-appointed assistant vice president for adaptive trials at US drug major Wyeth, explained to the Wall Street Journal that adaptive trials are "fundamentally different from what we currently do." The results of an ongoing study are constantly analyzed with various events triggering alterations to the study. For example, Dr Kyams said, if one treatment looks more effective, then a greater proportion of subjects can be transferred into that group, whilst less favorable lines can be reduced. Computer simulations are generally used to prepare for various trial scenarios.

"It helps pick winners and losers faster"