In the latest effort to oversee and minimize conflicts of interest among drugmakers and the clinical investigators involved in drug development, the US Food and Drug Administration (FDA) has issued draft guidance on financial disclosure rules for investigators. The guidance document is intended to update rules that have been in place for a decade. “During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” according to the agency, and “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.”
FDA Issues Draft Guidance For Investigator Conflicts (Pharmalot)
Draft Guidance for Clinical Investigators, Industry, and FDA Staff; Availability Financial Disclosure by Clinical Investigators (Regulations.gov)