The FDA stated that it will keep confidential information it receives from clinical trial sponsors on its investigators’ financial conflicts of interest “in almost all cases.”
According to a notice in the Aug. 18 Federal Register, clinical investigators must report to study sponsors sufficient, accurate information to enable the sponsor to complete certification and disclosure forms.
“Information such as a proprietary interest in the tested product is already public information and, therefore, releasable,” said the FDA in a statement. “Otherwise, the FDA will consider disclosed information as confidential and will consider release of such information only in circumstances in which questions of propriety clearly outweigh privacy interests. The FDA believes that such cases will involve only a small subset of clinical investigators.”
According to the agency, most clinical investigators will have no disclosable information to report to the sponsor. For those that do, most of this information will already be known by the sponsor. The investigator will need only to provide the sponsor with information concerning a significant equity interest in the sponsor, providing the sponsor is publicly held.
The FDA estimates that the amount of time spent in providing this disclosure information will be “minimal,” only about 10 hours. Given the fact that about 46,000 clinical investigators participate in covered clinical studies in a given year, this means, the FDA said, “a total of 4,600 burden hours is estimated for reporting by clinical investigators to sponsors in a given year.”