The National XXXX Institute audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06.

@entity5 @entity1 @entity0
BACKGROUND: The National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-06, a clinical trial sponsored by the National @entity5 Institute (NCI), has provided evidence of the value of lumpectomy and breast irradiation for treating @entity1 with @entity0 in an early stage. Publicity generated by the discovery that the study included fraudulent data on @entity1 enrolled by St. Luc Hospital in Montreal aroused concern about the overall accuracy of the data and conclusions. To address this concern, the NCI conducted an audit of other participating institutions. METHODS: In 1994, data on 1554 of the 1809 randomized @entity1 (85.9 percent) enrolled by centers other than St. Luc Hospital were audited at 37 clinical sites in North America. The audit included data on eligibility, survival, disease-free survival, the length of time to a recurrence of @entity5 in the ipsilateral breast, and documentation of signed informed consent. RESULTS: End points were assessed for all 1554 @entity1 , and eligibility was assessed for 1507 @entity1 ; 47 @entity1 were excluded because their forms were not complete or not returned. A total of 1429 @entity1 had their eligibility status verified. Of a total of 7770 data points examined with respect to the number of positive nodes at base line, treatment characteristics, first events (excluding death), recurrence of @entity5 in the ipsilateral breast, and survival, 7577 (97.5 percent) were verified, 123 (1.6 percent) could not be verified, and 70 (0.9 percent) were discrepant with the NSABP file. Of the 1554 @entity1 , 1340 (86.2 percent) had all audited items (including eligibility) verified, 69 (4.4 percent) had at least one discrepant item, and 113 (7.3 percent) had at least one unverified item (as a result of missing or incomplete data); 32 (2.1 percent) were not assessed for eligibility but had no other discrepant or unverifiable items. Written informed consent was documented for 1098 @entity1 before surgery and 210 after surgery; no date appeared on the signed form for 137. The informed-consent status was not verified for 71 @entity1 and could not be determined for 38. The rates of verification of end-point data and documentation of written informed consent were similar among the total-mastectomy group, the lumpectomy group, and the group treated by lumpectomy and breast irradiation. CONCLUSIONS: The audit confirms the adequacy of the data on which the reanalysis of Protocol B-06 and the results after 12 years of follow-up are based.
