FDA’s 2011 Draft Guidance on Financial Disclosure by Clinical Investigators – Overview of Recommendations

  • By: Staff Editor
  • Date: September 16, 2011
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The new FDA draft guidance on financial disclosure by clinical investigators is a revision of an earlier guidance document issued in March 2001.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.

According to the guidance, the FDA’s review of clinical investigator financial disclosure information alerts FDA staff to financial interests and arrangements that could lead to bias in covered clinical studies, and the steps sponsors have taken to minimize the risk of bias.
The FDA staff considers the financial disclosure information and the methods the sponsor used to minimize bias during the review of marketing applications to assess the reliability of the clinical data.
The draft guidance gives detailed definitions of the terms appearing in the regulation governing financial disclosure by clinical investigators, 21 CFR Part 54. The document defines the following terms:
Clinical Investigator
This term means any listed or identified investigator or sub-investigator who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the investigator or sub-investigator
Covered clinical study
This term refers to any study:
  • of a drug, biological product or device in humans submitted in a marketing application or reclassification petition that the applicant or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product)
  • in which a single investigator makes a significant contribution to the demonstration of safety (such as a safety study designed to address a particular safety concern and conducted by a small number of clinical investigators)
The term does not refer to:
  • Phase 1 tolerance studies
  • Pharmacokinetic studies
  • Most clinical pharmacology studies (unless they are critical to an efficacy determination)
  • Large open safety studies conducted at multiple sites
  • Treatment protocols
  • Expanded access protocols
This means the party who submits a marketing application to FDA for approval of a drug, device or biologic product or who submits a reclassification petition. The applicant is responsible for submitting the required certification and disclosure statements.
Sponsor of the covered clinical study
This means a party providing support for a particular study at the time it was carried out. A covered clinical study may have more than one sponsor for whom financial information will need to be collected.
Need to get a better understanding of clinical trial compliance? Find out by attending any of these ComplianceOnline webinars:
What are the disclosable financial interests and arrangements?
The document details what counts as disclosable financial interests and arrangements according to 21 CFR Part 54. These include:
  • 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.
The requirement applies to interests held during the period of clinical study and up to one year after completion of the study.
  • 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.
What actions can the FDA take for non-disclosure of finances by clinical investigators?
  • 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. 
If the FDA determines that a clinical investigator’s financial interests or arrangements may have compromised the veracity of clinical study data, it can:
  • 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
Additional Resources
­Read the FDA Draft Guidance on Financial Disclosures by Clinical Investigators in full


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