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Guidelines for quality assurance in multicenter trials: a position paper.

Publication ,  Journal Article
Knatterud, GL; Rockhold, FW; George, SL; Barton, FB; Davis, CE; Fairweather, WR; Honohan, T; Mowery, R; O'Neill, R
Published in: Control Clin Trials
October 1998

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.

Duke Scholars

Published In

Control Clin Trials

DOI

ISSN

0197-2456

Publication Date

October 1998

Volume

19

Issue

5

Start / End Page

477 / 493

Location

United States

Related Subject Headings

  • United States
  • Scientific Misconduct
  • Research Design
  • Quality Control
  • Quality Assurance, Health Care
  • Public Opinion
  • Public Health
  • National Institutes of Health (U.S.)
  • Multicenter Studies as Topic
  • Medical Audit
 

Citation

APA
Chicago
ICMJE
MLA
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Knatterud, G. L., Rockhold, F. W., George, S. L., Barton, F. B., Davis, C. E., Fairweather, W. R., … O’Neill, R. (1998). Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials, 19(5), 477–493. https://doi.org/10.1016/s0197-2456(98)00033-6
Knatterud, G. L., F. W. Rockhold, S. L. George, F. B. Barton, C. E. Davis, W. R. Fairweather, T. Honohan, R. Mowery, and R. O’Neill. “Guidelines for quality assurance in multicenter trials: a position paper.Control Clin Trials 19, no. 5 (October 1998): 477–93. https://doi.org/10.1016/s0197-2456(98)00033-6.
Knatterud GL, Rockhold FW, George SL, Barton FB, Davis CE, Fairweather WR, et al. Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials. 1998 Oct;19(5):477–93.
Knatterud, G. L., et al. “Guidelines for quality assurance in multicenter trials: a position paper.Control Clin Trials, vol. 19, no. 5, Oct. 1998, pp. 477–93. Pubmed, doi:10.1016/s0197-2456(98)00033-6.
Knatterud GL, Rockhold FW, George SL, Barton FB, Davis CE, Fairweather WR, Honohan T, Mowery R, O’Neill R. Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials. 1998 Oct;19(5):477–493.
Journal cover image

Published In

Control Clin Trials

DOI

ISSN

0197-2456

Publication Date

October 1998

Volume

19

Issue

5

Start / End Page

477 / 493

Location

United States

Related Subject Headings

  • United States
  • Scientific Misconduct
  • Research Design
  • Quality Control
  • Quality Assurance, Health Care
  • Public Opinion
  • Public Health
  • National Institutes of Health (U.S.)
  • Multicenter Studies as Topic
  • Medical Audit