Clinical Trials Need Major Remodeling By Carla Garnett, April 13, 2012.

We need to rethink the clinical trials system—from the ground up. That’s what Dr. Robert Califf proposed at a recent Mind the Gap seminar, “Innovative Approaches to Clinical Trials.”

“I hope to convince you that incremental changes in our clinical trials system will not be sufficient,” he said. “We really have to prepare ourselves for a major transformational change.”

Vice chancellor for clinical and translational research and director of the Duke Translational Medicine Institute, Califf has studied the business of conducting clinical studies for decades. Outlining some of the problems with the current system, he said the nation’s biggest challenge might be overcoming a mindset about the way we’ve always done clinical trials until now.

“You’ll see that in the context of defining the problem, it’s technically a non-problem,” he explained. “[The hurdle] turns out to be a social and cultural set of issues that we’re going have to get over if we want to make the next set of advances in health and health care.” Read more