As demonstrated in many FDA warning letters, a commonly cited source of bias in clinical research can be found in the financial ties between investigators and sponsors. Perhaps more clarity is needed in order for those in the clinical research industry to be brought into compliance with 21 CFR 54?
FDA just released a guidance for industry, “Guidance for Clinical Investigators, Industry and FDA Staff Financial Disclosure by Clinical Investigators.” As stated in the introduction, this guidance is intended to assist those parties with understanding 21 CFR 54. This regulation requires those who are submitting an application for a new product to disclose any information that may be seen as a conflict of interest in terms of compensation or financial interests.
It is not unusual for the innovations of individual physician investigators to receive research and development funding from larger organizations that possess the resources to bring these innovations to market, and under 21 CFR 54:
- It is the responsibility of sponsors to collect for each investigator who is not a full-or part-time employee either a certification of no financial conflict of interest (Form FDA 3454), or a disclosure of the financial arrangements between the sponsor and investigator (Form FDA 3455)
- These financial disclosures must be updated by the investigators if there are any changes in financial disclosure status throughout the study, until one year after the study is completed.
What happens if an applicant is unable to obtain required financial information? The guidance speaks to the term ‘due diligence’ and explains that it is a measure of activity expected from a reasonable and prudent person under a particular circumstance, in this case, collecting information about financial interests or arrangements. FDA expects that applicants will typically be able to obtain the required information because investigators are required to provide financial disclosure information to sponsors before participating in a clinical study.”
Another good point the guidance touches is whether financial disclosure will be part of a BIMO inspection at a clinical site. According to J2 of the guidance, “It is FDA’s policy that FDA investigators should ask the clinical investigator if he/she submitted information to the sponsor prior to initiation of the study and updated that information, as needed, for up to one year after completion of the study at the site.”
What have your experiences been with financial disclosure and 21 CFR 54? Do you believe this guidance will help shed light on some gray interpretational areas? Share your thoughts with us!
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