alexa An Analysis of United States Food and Drug Administration Warning Letters Issued to Clinical Investigators from 1996 through 2011
ISSN: 2155-9627

Journal of Clinical Research & Bioethics
Open Access

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Research Article

An Analysis of United States Food and Drug Administration Warning Letters Issued to Clinical Investigators from 1996 through 2011

Jessica A. Knowlton1* and Jim Y. Wan2

1The Hamilton Eye Institute, Department of Ophthalmology, University of Tennessee Health Science Center, Memphis, Tennessee 38163, USA

2Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee 38163, USA

*Corresponding Author:
Jessica A. Knowlton
930 Madison Avenue, Suite 314
Memphis, Tennessee 38163, USA
Tel: 901-448-1201
Fax: 901-448-1299
E-mail: [email protected]

Received Date: October 27, 2011; Accepted Date: December 14, 2011; Published Date: December 16, 2011

Citation: Knowlton JA, Wan JY (2011) An Analysis of United States Food and Drug Administration Warning Letters Issued to Clinical Investigators from 1996 through 2011. J Clinic Res Bioeth 2:122 doi: 10.4172/2155-9627.1000122

Copyright: © 2011 Knowlton JA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

The warning letter is a communication sent to sponsors, manufacturers and clinical investigators resulting from inconsistencies and inaccuracies found during FDA audits of clinical research-related activities. Warning letters to investigators can have a major impact on that physician’s practice and their affiliated institution. The objective of this research was to analyze the publicly available warning letters that were sent to clinical investigators during the years 1996 to 2011 to identify areas of deficiencies and educate current and future clinical investigators. The data was extracted from letters to Clinical Investigators published in the Electronic Reading Room on the FDA’s website.The specific regulationslisted in the letters that were deemed violated by the respective FDA auditor were used for data analysis and termed “infractions”.Between 1996 and 2011, 1,404 infractions were noted for 237 Clinical Investigators (mean = 5.14). The vast majority of these infractions occurred in 21 Code of Federal Regulation, parts 50, 312 and 812 (n= 215, 523 and 650 infractions, respectively) and reflected violations in the areas of informed consent, documentation and investigator responsibilities.During this timeframe, the average number of infractions per investigator per year did not decrease. Finally, the number of investigator warning letters that were issued was not correlated to the number of investigator audits. This data shows common deficiencies in clinical research programs and can assist investigators in developing preventative measures for future clinical research.

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