The Food and Drug Administration issued draft guidance (PDF) addressing questions about the financial disclosures of clinical investigators who conduct clinical studies of agency-regulated drugs, biologics and devices.
Draft guidance issued on financial disclosures
The draft guidance, published May 24, aims to revise the FDA's most recent guidance from 2001. It includes answers to what the agency says are the most frequently asked questions about clinical investigators' financial disclosures.
The document describes financial disclosures as compensation paid by the sponsor and of a value that it could have an effect on the study's outcome, when a clinical investigator has a “proprietary interest” in the product or equity interest in the public or privately owned sponsor, and significant payments of other sorts, including grants, research or honoraria.
The draft guidance also calls for comments about the circumstances in which the FDA can release information about clinical investigators' financial disclosures to the public.
The comment period ends July 25.
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