[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR54.1]

[Page 296]
 
                        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.