Give Patients a Role in Clinical Trial Design, FDA Official Says

Drug developers in personalized medicine will have more success if they work closely with patients before designing a clinical trial, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said.

It takes several years to develop a compound before it’s ready for testing in humans, and “you shouldn’t be sitting on your hands in a laboratory during that time,” Woodcock told Bloomberg BNA Nov. 16 in an interview in Boston. “You really ought to engage patients about their symptoms,” which will help tremendously in designing a clinical trial down the road, she said.

Personalized, ...