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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Knatterud, GL; Rockhold, FW; George, SL; Barton, FB; Davis, CE; Fairweather, WR; Honohan, T; Mowery, R; O'Neill, R

Published Date

  • October 1998

Published In

Volume / Issue

  • 19 / 5

Start / End Page

  • 477 - 493

PubMed ID

  • 9741868

International Standard Serial Number (ISSN)

  • 0197-2456

Digital Object Identifier (DOI)

  • 10.1016/s0197-2456(98)00033-6


  • eng

Conference Location

  • United States