Duke’s Dr. Robert Califf calls for a major overhaul of clinical trials in the U.S.

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.

Dr. Marjana Tomic-Canic

Normal human skin has a mind of its own. Wound it, even in the Petri dish, where you can grow massive sheets of it from a single biopsy, and it will start to heal itself.

But there is a population of patients, many elderly or with diabetes, whose wounds just don’t heed the chemical rallying cries of growth factors, cytokines and chemokines that instantly set to work once our protective covering has been breached.