[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: 21CFR54.5]

[Page 298-299]
 
                        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. 54.5  Agency evaluation of financial interests.

    (a) Evaluation of disclosure statement. FDA will evaluate the 
information disclosed under Sec. 54.4(a)(2) about each covered clinical 
study in an application to determine the impact of any disclosed 
financial interests on the reliability of the study. FDA may consider 
both the size and nature of a disclosed financial interest (including 
the potential increase in the value of the interest if the product is 
approved) and steps that have been taken to minimize the potential for 
bias.

[[Page 299]]

    (b) Effect of study design. In assessing the potential of an 
investigator's financial interests to bias a study, FDA will take into 
account the design and purpose of the study. Study designs that utilize 
such approaches as multiple investigators (most of whom do not have a 
disclosable interest), blinding, objective endpoints, or measurement of 
endpoints by someone other than the investigator may adequately protect 
against any bias created by a disclosable financial interest.
    (c) Agency actions to ensure reliability of data. 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:
    (1) Initiating agency audits of the data derived from the clinical 
investigator in question;
    (2) Requesting that the applicant submit further analyses of data, 
e.g., to evaluate the effect of the clinical investigator's data on 
overall study outcome;
    (3) Requesting that the applicant conduct additional independent 
studies to confirm the results of the questioned study; and
    (4) Refusing to treat the covered clinical study as providing data 
that can be the basis for an agency action.