Now more than ever, the work of clinical researchers is “absolutely critical” to identifying and vetting potential life-saving drugs and devices, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf told attendees of the recent ACRP 2016 Meeting & Expo in Atlanta, Ga. “What you’re doing in clinical research is giving us the information and the knowledge we need to make the best decisions,” Califf said.
Lauding the conference as an opportunity for clinical research coordinators and others in the industry to share ideas and address “clouds on the horizon” in clinical research, Califf encouraged industry professionals to take their work seriously and recognize the sizable responsibilities they face. Simply put, clinical research “determines which products make it to the market,” he said.
He singled out a few of those “clouds” in his address. For example, the cost of clinical research is rising at an alarming rate. Califf cited data that suggest the cost of clinical trials is rising eight times as fast as the consumer price index.
He also asked attendees to take a good, hard look before falling into the trap of believing “one size fits all” in every aspect of clinical research. Stressing a “quality by design” approach, he noted as an example that early-phase clinical trials need to be heavily detailed, while trials further down the line sometimes have to address genomics and other biometric challenges.
Also, “there’s a deluge of data” coming from devices worn by trial subjects, Califf said. The trick is having best practices in place to sort through those data in the most effective way, he stressed.