FDA reviews data generated in clinical studies to determine whether medical device applications are approvable. Financial interest of a clinical investigator is one potential source of bias in the outcome of a clinical study. To ensure the reliability of the data, the financial interests and arrangements of clinical investigators must be disclosed to FDA.
This requirement applies to any clinical study submitted in a marketing application that the applicant or FDA relies on to establish that the product is effective or is used to show equivalence to an effective product, and any study in which a single investigator makes a significant contribution to the demonstration of safety. The requirement does not apply to studies conducted under the emergency use, compassionate use, or treatment use provisions. Financial compensation or interests information is used, in conjunction with information about the design and purpose of the study, as well as information obtained through on-site inspections, in the agency's assessment of the reliability of the data.
Anyone who submits a Premarket Approval or Premarket Notification 510(k) after February 2, 1999 that contains a covered clinical study must submit certain information concerning the compensation to, and financial interests of, any clinical investigator conducting covered clinical studies in the application. Applicants must certify to the absence of certain financial interests of clinical investigators on Financial Interest Form: Certification: Financial Interests and Arrangements of Clinical Investigations FDA Form 3454 http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3454.pdf or to disclose those financial interests on Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3455.pdf.
The financial arrangements that must be disclosed include the following:
This requirement applies to investigators and subinvestigators including their spouses and dependent children, but does not apply to full or part-time employees of the sponsor or to hospital or office staff.
Please note that if the study was completed prior to February 2, 1999, the requirements are reduced. That is, the sponsor does not need to report equity interest in a publicly held company or significant payments of other sorts. Other reporting still applies.
Sponsors are responsible for collecting financial information from investigators and clinical investigators are responsible for providing financial disclosure information to the sponsor.The investigator's agreement with the sponsor should require the investigator to provide to the sponsor accurate financial disclosure information. (See Responsibilities). Certification or disclosure information should not be included in the IDE application.
If FDA determines that the financial interests of any clinical investigator raise a serious question about the integrity of the data, FDA will take any action it deems necessary to ensure the reliability of the data including:
Initiating agency audits of the data derived from the clinical investigator in question;
Requesting 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;
Requesting that the applicant conduct additional independent studies to confirm the results of the questioned study; and
Refusing to use the data from the covered clinical study as the primary basis for an agency action, such as PMA approval or 510(k) clearance.
Please note that FDA does NOT prohibit financial compensation to clinical investigators nor does FDA require or recommend divesture. FDA believes that divestiture could adversely affect development of new products.
References:
21
CFR 54
21
CFR 812.110(d)
21
CFR 812.43(c)(5)
Guidance for Industry: Financial Disclosure by Clinical Investigators
http://www.fda.gov/oc/guidance/financialdis.html
Financial Interest Form: Certification: Financial Interests and Arrangements
of Clinical Investigations FDA Form 3454
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3454.pdf
Financial Interest Forms: Disclosure: Financial Interests and Arrangements
of Clinical Investigators FDA Form 3455
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3455.pdf
Last modified date: July 21, 2003