[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR54.1]
[Page 291]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 54 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS--Table of Contents
Sec. 54.1 Purpose.
(a) The Food and Drug Administration (FDA) evaluates clinical
studies submitted in marketing applications, required by law, for new
human drugs and biological products and marketing applications and
reclassification petitions for medical devices.
(b) The agency reviews data generated in these clinical studies to
determine whether the applications are approvable under the statutory
requirements. FDA may consider clinical studies inadequate and the data
inadequate if, among other things, appropriate steps have not been taken
in the design, conduct, reporting, and analysis of the studies to
minimize bias. One potential source of bias in clinical studies is a
financial interest of the clinical investigator in the outcome of the
study because of the way payment is arranged (e.g., a royalty) or
because the investigator has a proprietary interest in the product
(e.g., a patent) or because the investigator has an equity interest in
the sponsor of the covered study. This section and conforming
regulations require an applicant whose submission relies in part on
clinical data to disclose certain financial arrangements between
sponsor(s) of the covered studies and the clinical investigators and
certain interests of the clinical investigators in the product under
study or in the sponsor of the covered studies. FDA will use this
information, 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.
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