CLINICAL INVESTIGATOR FINANCIAL DISCLOSURE CHECK-OFF BOX PROPOSED BY HOPKINS' BLAKE; FDA BACKS TAILORING REGS TO ISOLATE MOST "PERNICIOUS" CASES
This article was originally published in The Gray Sheet
Executive Summary
Clinical investigators should disclose to FDA whether their financial involvement with a study sponsor exceeds a certain threshold, but they should not be required to make specific disclosures unless the agency so requests, Johns Hopkins Executive Vice Dean David Blake, PhD, suggested at an FDA Science Board meeting March 29.