Dr. Robert Califf, former commissioner of the Food and Drug Administration, said Wednesday the current clinical trial system isn’t working and outlined his vision for a future system based on high-quality evidence and widespread data sharing.
“Beyond early phase intensive mechanistic exploratory trials, I think the clinical trials enterprise has gone awry,” he said, speaking at a conference on clinical trials hosted by the New York Academy of Sciences, “It’s become unnecessarily expensive, cumbersome, arcane, and it’s causing, I think, a search for alternatives partly out of desperation, because the way it’s being done now isn’t answering the questions people are most concerned about.”
