An On-Site Audit of the South African Trial of High-Dose Chemotherapy for Metastatic Breast Cancer and Associated Publications

Authors

Raymond B. Weiss

Raymond B. Weiss, Geraldine G. Gill, Clifford A. Hudis

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PURPOSE: The randomized study reported by Bezwoda et al of high-dose chemotherapy (HDC) for treatment of metastatic breast cancer was audited on site to verify the study results. Additional published studies were reviewed to determine whether they had been subject to the required institutional oversight.

PATIENTS AND METHODS: Ninety patients were reported to have been randomized and treated on this trial. A log of the names, hospital numbers, entry dates, and regimen received had been provided by the principal investigator. A search of more than 15,000 sets of medical records available from two Johannesburg hospitals was performed to locate records for as many of these 90 patients as possible. Standard auditing techniques were used. Additional clinical trials published by Bezwoda were compared against the minutes of the University of the Witwatersrand Committee for Research on Human Subjects to verify review and approval.

RESULTS: Records for only 61 of the 90 patients could be found. Of these 61, only 27 had sufficient records to verify eligibility for the trial by the published criteria. Of these 27, 18 did not meet one or more eligibility criteria. Only 25 patients appeared to have received their assigned therapy temporally associated with their enrollment date, and all but three of these 25 received HDC. The treatment details of individual patients were at great variance from the published data. Nine other trials reported by Bezwoda were not reviewed or approved by the appropriate institutional committee despite statements to the contrary in the publications.

CONCLUSION: The multiple publications of this study do not report verifiable data, and nine other publications coauthored by the principal investigator contain at least one major untrue statement.