US CT review system under fire from GAO: dummy firm was eligible for fed funds

The US Government Accountability Office has exposed worrying flaws in the independent institutional review board system, in a series of  exercises designed to test the extent to which unsafe clinical trials  could be licensed in the USA. A company in Colorado authorized a study  application made by fictitious physicians and which the GAO designed  to contain specifications that ought to have triggered concerns of  "significant risk." Although this exercise involved studies for a bogus  medical device, the GAO's report noted that, "each year, millions of  Americans are enrolled in clinical trials of experimental drugs and  medical devices conducted in over 350,000 locations throughout the USA."

One of the incidents that triggered the GAO's investigation occurred  in 2002. The agency stated that "a 47-year-old man died after his heart  stopped beating while participating in an experimental trial of  antipsychotic medication at a Texas research center. Before his death,  the man spent 22 days suffering from fever, severe diarrhea, a rapid  heartbeat and kidney failure while under the care of researchers. The  warning label for the experimental medication listed some of these  serious side effects and other signs of heart failure, but the IRB  failed to ensure the risks were communicated to participants at the  outset of the trial."

The GAO found that one firm it contacted, Coast Independent Review  Board, based in Colorado Springs, approved a clinical study plan which  had been rejected by two rival firms on safety grounds. Among the  failings claimed by the GAO were: not checking the applicant's  credentials; not verifying what was a false statement that a medical  device used in the trial was approved by the Food and Drug  Administration; and conducting the entire process via e-mail or fax.