Robert M. Califf, M.D., who resigned as FDA Commissioner at the end of President Barack Obama’s administration in January, will keep busy with a pair of new appointments.
Dr. Califf has returned to the Duke Clinical Research Institute (DCRI), which he founded in 2006, with a new appointment as the Donald F. Fortin professor of cardiology. He spent 33 years with Duke University School of Medicine and the Duke University Medical Center—most notably as its vice chancellor of clinical and translational research and head of DCRI—before being confirmed as FDA commissioner last year following nomination by Obama.
In his new position at DCRI, Dr. Califf has commented on the prospect of regulatory changes at FDA designed to speed up decisions on new drugs—changes promised repeatedly in recent weeks by President Donald Trump. Earlier this month, Trump named Scott Gottlieb, M.D., a former FDA deputy commissioner, as his nominee to run the agency.
“Shortening and expediting is a great idea, but it needs to be done without lowering the standards,” Dr. Califf told The Duke Chronicle, the University’s independent student newspaper.
He added that more than 90% of drug candidates that enter clinical trials currently do not get authorized to be marketed. Should regulations be relaxed to increase the number of such drugs approved, he said, “a lot of people are going to get hurt or end up taking ineffective drugs.”
Dr. Califf also been named chair of the People-Centered Research Foundation (PCRF), a new nonprofit foundation “committed to accelerating people-driven research that is faster, more user friendly for patients and providers, and less costly,” according to its website.
PCRF was established by investigators with the National Patient-Centered Clinical Research Network (PCORnet), a national coalition of networks formed to support the conduct of clinical outcomes research.
“PCRF was formed by PCORnet investigators as a means of pursuing long-term sustainability of PCORnet,” PCORI said in a statement to GEN. PCORnet was created by the Patient-Centered Outcomes Research Institute (PCORI), the private nonprofit created by the Affordable Care Act, which Trump has proposed repealing and replacing with a new healthcare law.
“PCRF will work in parallel and in collaboration with PCORnet and its participating networks, which will continue to receive infrastructure funding from PCORI through contracts that began in 2015,” PCORI stated. “The formation of PCRF is the natural next step in PCORI’s long-standing expectation for a long-term sustainability plan for PCORnet as a platform for allowing the conduct of health research faster, more efficiently, with greater power, and at lower cost, that has been possible to date.”
As PCRF begins to plan for PCORnet’s long-term future, PCORI said “PCORnet continues to build its capacity to serve as a national resource for a range of health research that will serve the public good, including the patient-centered outcomes studies that PCORI was created to fund.”
In addition to sustaining PCORnet, PCRF said on its website it “will provide retrospective observational research using its data network, prospective research that collects new data from patients, and high-impact clinical trials.”
“A balanced mix of support from government, foundations, and industry will sponsor the studies,” the Foundation added.