FDA’s 2011 Draft Guidance on Financial Disclosure by Clinical Investigators – Overview of Recommendations

• By: Staff Editor
• Date: September 15, 2011

The new FDA draft guidance on financial disclosure by clinical investigators is a revision of an earlier guidance document issued in March 2001. This new document aims to address the issues raised by the Office of the Inspector General (OIG), Department of Health and Human Services in its report on the FDA’s oversight of clinical investigators’ financial information as well as questions the agency has received from the industry and concerned members of the public.

• Compensation made to the investigator by any sponsor of the covered clinical study in which the value of compensation could be affected by study outcome.
• A proprietary interest in the tested product including, but not limited to, a patent, trademark, copyright or licensing agreement.
• Any equity interest in any sponsor of the covered clinical study. This can include:
  • Any ownership interest,
  • Stock options, or
  • Other financial interest whose value cannot be readily determined through reference to public prices.

• Any equity interest in any sponsor of the covered study if the sponsor is a publicly held company and the interest exceeds $50,000 in value. The requirement applies to interests held during the time the clinical investigator is carrying out the study and for one year following completion of the study.
• Significant payments of other sorts (SPOOS), which are:
  • Payments that have a cumulative monetary value of $25,000 or more made by any sponsor of a covered study to the investigator or the investigator’s institution, during the time the clinical investigator is carrying out the study and for one year following completion of the study.
  • Payments that support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies (e.g., a grant to the investigator or to the institution to fund the investigator’s ongoing research or compensation in the form of equipment)
  • Payments that provide other reimbursements such as retainers for ongoing consultation or honoraria.

• The FDA can refuse to file a marketing application that does not contain the financial information required by 21 CFR Part 54.
• The agency can also refuse to file certification by the applicant that the applicant has acted with due diligence to obtain the information but was unable to do so stating a sufficient reason. 

• Initiate agency audits of the data derived from the clinical investigator in question
• Request that the applicant submit further analyses of data, e.g., to evaluate the effect of the clinical investigator's data on the overall study outcome
• Request that the applicant conduct additional independent studies to confirm the results of the questioned study
• Refuse to treat the covered clinical study as providing data that can be the basis for an agency action