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The FDA issued a warning letter to the Vail Valley Medical Center Institutional Review Board (IRB) saying that it was a conflict of interest for its vice chairman to vote to approve a clinical trial protocol that he himself had authored.
While controversy surrounds potential conflicts of interest among institutional review board (IRB) members, no one knows who owns the boards themselves.
The FDA has sent a warning letter to the Galesburg, Ill., institutional review board (IRB), a rare rebuke of an organization that is supposed to provide ethical oversight of clinical trials involving human research subjects.
According to an industry analyst, the different boards and regulations that govern adverse event (AE) reporting cause confusion and inconsistencies rather than clear and solid guidance.
Clinical investigators are increasingly turning to industry sponsors to help them cover “hidden” trial costs — such as prestudy services — that are starting to eat away at research institutions’ operating budgets.
Clinical trials professionals hope the FDA will have a new adverse event reporting system (AERS) in place before the end of next year to help streamline the reporting process, which has become increasingly onerous for researchers.
Boehringer Ingelheim Pharmaceuticals has been cited by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) for running a journal advertisement containing unsubstantiated superiority claims about its stroke drug Aggrenox.
Understanding the differences between industry- and investigator-initiated trials is the key to developing investigator-initiated research (IIR) proposals that meet the approval of department chairs, institutional review boards (IRBs) and industry sponsors, according to William Hirschhorn, director of graduate research education and policy at Drexel University College of Medicine.