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CCR Perspectives in Drug Approval

U.S. Food and Drug Administration Inspections of Clinical Investigators: Overview of Results from 1977 to 2009

Sonia K. Morgan-Linnell, David J. Stewart and Razelle Kurzrock
Sonia K. Morgan-Linnell
1Department of Investigational Cancer Therapeutics (Phase I Program), University of Texas MD Anderson Cancer Center, Houston, Texas;
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David J. Stewart
3Division of Medical Oncology, University of Ottawa, Ottawa, Canada
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Razelle Kurzrock
2Center for Personalized Cancer Therapy, Moores Cancer Center, University of California San Diego, San Diego, California; and
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  • For correspondence: rkurzrock@ucsd.edu
DOI: 10.1158/1078-0432.CCR-13-3206 Published July 2014
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Abstract

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research is responsible for evaluating drug safety and efficacy, including oversight of clinical trials and principal investigators. The FDA Clinical Investigator Inspection List (CIIL) contains online, detailed, relevant information of all FDA inspections. We reviewed FDA inspections of clinical investigators to ascertain their outcome and included all inspections on the list (July 1977 through December 31, 2009; n = 9,481 inspections). Eighty-eight percent of inspections were “data audit” (primary purpose = verification of data), and the rest (12%) were “for cause.” The number of inspections each year significantly increased over time (P < 0.0001) and averaged 350 per year in the past decade. No deficiencies were found in only 11.2% of all “data audit” and 5% of all “for cause” inspections. Only 31% of inspections resulted in “no action indicated.” About two thirds of inspections resulted in some finding, requiring either voluntary investigator action (61.3% of inspections) or official FDA action (3.9%). The most frequently cited deficiencies were failure to follow investigational plan (34%), inadequate informed consent form (28%), and inadequate/inaccurate records (27%). In conclusion, over the past decade, the FDA has performed approximately 350 inspections per year, with the number increasing over time. The vast majority of FDA inspections yield deficiency findings and, as a result, only about one third of inspections have an outcome of “no action indicated.” Clin Cancer Res; 20(13); 3364–70. ©2014 AACR.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Received December 4, 2013.
  • Revision received March 4, 2014.
  • Accepted March 7, 2014.
  • ©2014 American Association for Cancer Research.
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Clinical Cancer Research: 20 (13)
July 2014
Volume 20, Issue 13
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U.S. Food and Drug Administration Inspections of Clinical Investigators: Overview of Results from 1977 to 2009
Sonia K. Morgan-Linnell, David J. Stewart and Razelle Kurzrock
Clin Cancer Res July 1 2014 (20) (13) 3364-3370; DOI: 10.1158/1078-0432.CCR-13-3206

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U.S. Food and Drug Administration Inspections of Clinical Investigators: Overview of Results from 1977 to 2009
Sonia K. Morgan-Linnell, David J. Stewart and Razelle Kurzrock
Clin Cancer Res July 1 2014 (20) (13) 3364-3370; DOI: 10.1158/1078-0432.CCR-13-3206
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Clinical Cancer Research
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