New guidance from the US Food and Drug Administration revises financial disclosure requirements made by medical device clinical study sponsors to clinical investigators.
The revised guidance comes following recommendations from the US Department of Health and Human Services’ Office of Inspector General that the FDA should ensure that sponsors provide complete financial information regarding all their clinical investigators; that relevant agency personnel consistently review financial information; and that clinical study sponsors submit financial information for their clinical investigators before studies begin.
Among requirements outlined in the guidance:
- Applicants must identify all clinical investigators involved in clinical studies pertaining to their submissions to the FDA
- Clinical investigators who are also full- or part-time employees of a sponsor must be identified as such
- Applicants must either provide certification stating that no financial interests outlined in 21 CFR § 54.4(a)(3), or fully disclose such arrangements as well as steps taken to minimize any potential bias to FDA reviewers
Financial interests covered by the guidance include:
- Any compensation to a clinical investigator by a study sponsor that could potentially affect the study’s outcome
- Any proprietary interest in the medical device undergoing clinical study
- Any equity stake held by a clinical investigator in a study sponsor (if the sponsor is a public company) that cannot be determined using publically available references
- Any equity stake of more than $50,000 in a study sponsor held by a clinical investigator
Although sponsors are not required to provide financial disclosure information to the FDA until they submit their marketing applications, they must collect such information from their clinical investigators before the investigators participate in clinical studies, such as during an FDA Pre-Submission or Pre-IDE consultation.
Failure to comply with financial disclosure requirements could result in the FDA refusing a sponsor’s marketing application. In addition, the regulator has the authority to audit data from clinical investigators, request additional data analysis from the sponsor, or request that the sponsor undertake additional studies to confirm results.