The U.S. Food and Drug Administration (“FDA”) recently issued three Warning Letters, all related to issues involving clinical trials.
All three letters were critical of the Institutional Review Boards (“IRBs”) charged with overseeing the clinical trials.
The first Warning Letter was sent to a hospital in Idaho for serious violations learned during an agency inspection. The agency found that the hospital’s IRB signed off on four clinical trials involving an anti-psychotic drug without adhering to special protections that apply to studies involving children.
Additionally, FDA determined that the IRB failed to notify investigators of conditions that applied to the IRB’s approval of studies, some of which involved the use of the anti-psychotic drug in adolescents with schizophrenia. Moreover, the IRB failed to review certain research as frequently as required, inadequately documented its activities, and reviewed research without a majority of its members present.
The second and third Warning Letters were issued to a pain clinic and its owner.
The pain clinic has locations in California and Indiana. The agency found that the IRB failed to have adequate written procedures in place to govern its functions, had a potential conflict of interest when a voting member was also involved in research, and failed to adequately document its activities. Additionally, the IRB approved an informed consent document that failed to discuss the purpose of the research, the duration of patient participation, and whether procedures were experimental.
The FDA also determined that the center failed to acquire an Investigational Device Exemption (“IDE”) for its device, which was required since the device carries significant risks; nine subjects were treated by the device. Moreover, the agency found that informed consent was not obtained properly, record-keeping was insufficient, and the trial was not conducted according to its approved plan.