Coast first casualty in US overhaul of IRB system
pharmafile | May 5, 2009 | News story | Research and Development | FDA, US
A US company offering institutional review board services to sponsors of clinical trials has been forced to close its doors in the wake of a federal investigation.
Coast IRB fell foul of a Government Accounting Office (GAO) sting operation that sought to identify IRBs which rubber-stamped clinical trial protocols without carrying out due-diligence.
The GAO drew up a fictitious protocol involving a medical device which was similar to those deemed by the US Food and Drug Administration (FDA) to carry "significant risk".
Two of three institutional review boards (IRBs) approached for approval rejected the application, but Coast approved it despite false – and easily checked – claims that the device was already approved for sale.
That was enough to earn Coast an FDA warning letter and a lot of negative media, and the firm said in a letter that despite an immediate effort to reform practices "several key customers have already pulled their studies from Coast IRB".
Another commercial IRB, Chesapeake Research Review, has stepped in to provide monitoring and IRB oversight for Coast's ongoing clinical studies as the company shuts down.
The GAO report raised more fundamental concerns than one rogue company, however, and has prompted calls for the entire IRB system in the US to be placed under urgent review as it is "vulnerable to unethical manipulation".
Other elements of the undercover operation included the setting up of a fake IRB which was able to win registration by the Department of Health and Human Services, get an assurance approval number issued by the HHS and list a bogus medical device company in its online directory of approved assurances.
The report's findings were presented at a hearing of the House Subcommittee on Oversight and Investigations in late-March. At the meeting the FDA said that it has plans to require IRBs to register with the agency and is working on guidelines to help trial sponsors and IRBs meet acceptable standard levels.
The new registration process, which is scheduled to start up in July, will create a database of IRBs to make it easier for the FDA to inspect and communicate with them.
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