It appears that a Colorado company that drug and medical device makers pay to oversee patient safety during clinical trials does a poor job of supervising medical trials. Recently, the company, Coast Independent Review Board of Colorado Springs, approved a study that didn’t even exist. In an interesting move, undercover federal investigators created a sham medical study to see how closely companies like Coast evaluate the studies they are paid to review. This company approves clinical-trial designs and patient-safety guidelines, which are critically important assignments. Companies and medical institutions are required to have an “independent” institutional review board approve these trials when they experiment on human subjects.
Two of Coast’s competitors correctly refused to approve the study’s design. But Coast approved a trial, which involved a make-believe surgical product called Adhesiabloc as well as researchers who did not exist. The company may be able to explain how it has approved a sham study, but I believe that will be most difficult. In fact, the company has agreed not to do any more trials for the drug industry. This was at the request of the FDA which said it had “serious concerns” about “Coast’s ability to protect human subjects.”
Source: New York Times
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