Conflict of interest can be defined as occurring when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other. Per the regulations, most clinical trials require disclosure of conflict of interest (COI). This is required by the investigator(s) to the sponsor, then from the sponsor to the FDA. The FDA then considers whether adequate steps are taken in the design, conduct, reporting and analysis of studies to minimize bias.
In 2012, the FDA released a guidance called “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.” This guidance also touches on 21 CFR 54; Financial disclosure, which can be a source of bias for the outcome of a study. The goal of this regulation is to protect the integrity and reliability of clinical data.
While the guidance is specific to advisory committees, it will help provide clarity to the FDA processes, and standardize of public disclosure of the COI information. In the news-release the Agency stated it based the draft guidance on the expectation that:
- The information would help the public understand the nature of the potential conflict and FDA's decision-making
- Individuals invited as advisory committee members would agree to the inclusion of this level of detail as a routine part of required disclosures
- The guidance will increase the transparency of FDA's decisions regarding advisory committee member participation
- This will not significantly deter current and potential advisory committee members from service on those committees
Advisory committees are important to the FDA. According to the FDA website, Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food. And while the FDA makes the final decision, it’s important for the Agency to receive impartial, accurate information.
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