Controversial clinical trial reviewers close

A company that reviewed proposals for clinical trials and became the target of a governmental investigation has decided to close.

Just last week the company, Coast IRB of Colorado Springs, Colorado, pledged to address federal concerns that arose after the company’s ethical review board unanimously approved a fictitious clinical trial that was designed by investigators with the US Government Accountability Office. The fabricated trial, to be led by a fictitious doctor with a faked medical license, was poorly documented and was called “the riskiest thing I’ve ever seen” by a board member at another review company. (For more details on the investigation, see this earlier blog post.)

On 14 April, the US Food and Drug Administration released a warning letter, and noted that Coast IRB would not be reviewing new trials or enrolling additional patients in ongoing trials until the agency’s concerns were addressed. The move was expected to affect as many as 300 trials and 3,000 researchers. This week, the company threw in the towel altogether.

Leave a Reply

Your email address will not be published. Required fields are marked *