Doctor’s Role in Clinical Trial Quality Likely Takes Center Stage with the New FDA Commissioner
[Posted on: Thursday, September 24, 2015]

This week President Obama announced the appointment of Dr. Robert Califf at the new Commissioner of the FDA. This was no surprise; Dr. Califf had already been acting as the FDA Commissioner since his hiring by FDA earlier this year. Dr. Califf’s major achievement before coming to FDA was creation of Clinical Research Institute at Duke University, which along with FDA launched the Clinical Trial Transformation Initiative (CTTI). Dr. Califf also is one of the first FDA Commissioners to come to the Agency with extensive and close relations with the drug industry. His bio lists multiple pharma and biotech companies where he participated as a consultant, advisor, clinical investigators, and champion. In all fairness, Dr. Califf claims that all his earnings from industry collaborations were donated to charities. He also has been a strong advocate of training by doctors to be better investigators even proposing that participation on clinical trials be a professional standard for physicians and clinical research principles be taught at medical schools. All in all, for the first time, we have a leader at FDA who has been in the trenches with the industry so likely appreciates the process of drug development well. Some concerns have been raised due to his past ties with the industry which are misplaced; a leader of the regulatory agency should have good relations with the industry it regulates as they work for mutual beneficence. Clinical trials are the backbone of discovery and approval of new treatments and his first-hand experience in that should pay dividends at FDA by further strengthening the rules, policies and guidance aimed at making doctors better researchers.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research