Investigator financial disclosure prior to Phase III trials urged at FDA workshop.
This article was originally published in The Tan Sheet
Executive Summary
FINANCIAL DISCLOSURE BY INVESTIGATORS PRIOR TO PHASE III efficacy studies should be required by FDA, Association of American Medical Colleges Committee on Research Integrity member David Blake, PhD, urged FDA at a July 20 meeting on the agency's proposed investigator financial disclosure regulation. Blake argued that "to be effective, disclosure and management of possible conflicts must occur before research is undertaken." He added that "FDA's approach...presents both ethical and financial concerns."