GUIDELINES FOR QUALITY ASSURANCE IN MULTICENTER TRIALS - A POSITION PAPER

In the wake of reports of falsified data in one of the trials of the N ational Surgical Adjuvant Project for Breast and Bowel Cancer supporte d by the National Cancer Institute, clinical trials came under close s crutiny by the public, the press, and Congress. Questions were asked a bout the quality and integrity of the collected data and the analyses and conclusions of trials. In 1995, the leaders of the Society for Cli nical 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 i ntegrity and auditing. In consultation with Drs. DeMets and Green, the co-chairs selected other members (Ms. France 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 sub committee considered ''how clean clinical trial data should be, to wha t extent auditing procedures are required, and who should conduct audi ts and how often.'' During the initial discussions, the subcommittee c oncluded that data auditing was insufficient to achieve data integrity . Accordingly, the subcommittee prepared this set of guidelines for st andards of quality assurance for multicenter clinical trials. We inclu de recommendations for appropriate action if problems are detected. (C ) Elsevier Science Inc. 1998.