Healthy Skepticism Library item: 15001

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Levinson DR
The Food and Drug Administration’s Oversight of Clinical Investigator’s Financial Information
: FDA 2009 Jan
http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf

Abstract:

OBJECTIVE
1. To describe the extent and nature of clinical investigators’ disclosed
financial interests reported to the Food and Drug Administration
(FDA) for marketing applications approved in fiscal year (FY) 2007.
2. To assess FDA’s oversight of clinical investigators’ financial
information.
BACKGROUND
Most new drugs, biological products, and medical devices undergo
clinical trials on human subjects before they are marketed in the United
States. Sponsors, generally pharmaceutical or device companies,
oversee clinical trials conducted by clinical investigators. Before clinical
trials begin, sponsors submit a pretrial application to FDA outlining
their study design. After clinical trials are completed, sponsors wishing
to market their product submit a marketing application to FDA.
Sponsors must collect financial information from clinical investigators
before clinical trials. However, sponsors submit financial information to
FDA only when they submit their marketing application after clinical
trials end. For each clinical investigator, sponsors submit a financial
form either certifying that the investigator does not have a financial
interest or disclosing the financial interest. Federal regulations also
allow sponsors to indicate that they acted with due diligence but were
unable to obtain financial information from a clinical investigator. For
each disclosed financial interest, sponsors must attach details of the
financial interest and a record of their actions to minimize potential
bias toward clinical trial results.
FDA assigns marketing applications to a multidisciplinary team for
review. Reviewers evaluate financial information as well as sponsors’
actions to minimize any potential bias related to clinical investigators’
disclosed financial interests. Reviewers provide written notes that are
used to determine whether a marketing application should be approved
by FDA. If reviewers suspect that disclosed financial interests
compromised data integrity, they are required to take action to ensure
the reliability of the data.
We reviewed financial forms, attachments, and accompanying FDA
review notes for all 118 marketing applications approved by FDA in
FY 2007. We also reviewed FDA regulations and guidance, conducted
structured interviews with FDA officials, and sent an electronic survey
to FDA reviewers.