[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: 21CFR54.5]
[Page 293]
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.
(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.
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