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Guidelines for quality assurance in multicenter trials: a position paper.
- Source :
-
Controlled clinical trials [Control Clin Trials] 1998 Oct; Vol. 19 (5), pp. 477-93. - Publication Year :
- 1998
-
Abstract
- In the wake of reports of falsified data in one of the trials of the National Surgical Adjuvant Project for Breast and Bowel Cancer supported by the National Cancer Institute, clinical trials came under close scrutiny by the public, the press, and Congress. Questions were asked about the quality and integrity of the collected data and the analyses and conclusions of trials. In 1995, the leaders of the Society for Clinical Trials (the Chair of the Policy Committee, Dr. David DeMets, and the President of the Society, Dr. Sylvan Green) asked two members of the Society (Dr. Genell Knatterud and Dr. Frank Rockhold) to act as co-chairs of a newly formed subcommittee to discuss the issues of data integrity and auditing. In consultation with Drs. DeMets and Green, the co-chairs selected other members (Ms. Franca Barton, Dr. C.E. Davis, Dr. Bill Fairweather, Dr. Stephen George, Mr. Tom Honohan, Dr. Richard Mowery, and Dr. Robert O'Neill) to serve on the subcommittee. The subcommittee considered "how clean clinical trial data should be, to what extent auditing procedures are required, and who should conduct audits and how often." During the initial discussions, the subcommittee concluded that data auditing was insufficient to achieve data integrity. Accordingly, the subcommittee prepared this set of guidelines for standards of quality assurance for multicenter clinical trials. We include recommendations for appropriate action if problems are detected.
- Subjects :
- Bias
Costs and Cost Analysis
Data Collection
Government Agencies
Humans
Mass Media
Medical Audit
National Institutes of Health (U.S.)
Public Opinion
Quality Control
Research Design
Scientific Misconduct
United States
Clinical Trials as Topic standards
Guidelines as Topic
Multicenter Studies as Topic standards
Quality Assurance, Health Care classification
Quality Assurance, Health Care economics
Quality Assurance, Health Care methods
Quality Assurance, Health Care organization & administration
Subjects
Details
- Language :
- English
- ISSN :
- 0197-2456
- Volume :
- 19
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Controlled clinical trials
- Publication Type :
- Academic Journal
- Accession number :
- 9741868
- Full Text :
- https://doi.org/10.1016/s0197-2456(98)00033-6