Analysis of FDA Warning Letters issued to investigators in oncology clinical trials from 1997 to 2002.
S. M. Sharp;
Winship Cancer Institute, Atlanta, GA
Abstract: Background: The FDA conducts inspections of clinical trials of investigational drugs and devices. When very serious problems in the conduct of the trial are discovered the FDA notifies the responsible investigator through the issuance of a Warning Letter ("WL").
This study examines the frequency of such actions and the specific nature of the problems identified by the FDA.
Methods: All WLs issued by the FDA from Jan. 1997 through Dec. 2003 publicly available under the Freedom of Information Act were reviewed and the violations of Federal Regulations alleged were categorized using a content analysis procedure.
The violations of Federal Regulations that formed the basis for the complaint alleged in the WL were reviewed and categorized using a content-analysis approach.
Results: 5,896 WLs were issued during this period; 97 (1.65%) to clinical investigators, of which 15 (15.5%) were for oncology trials; 66.7% of those for oncology trials went to academic investigators.
The most frequent violations alleged were: failure to meet the general obligation of an investigator (86.7%), failure to maintain required records (66.7%), failure to properly report serious adverse events (46.7%) and failure to obtain proper informed consent ((40%).
Conclusions: Although the absolute number of WLs for oncology trials is small, they represent a disproportionate percentage of those issued to clinical investigators and provide evidence of serious problems in the conduct of some studies.
By examining the problems discovered during FDA inspections opportunities for improvement in investigator training, trial design and monitoring can be identified.
Abstract No: 6093
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