Initiating Clinical Trials

This Note describes and analyzes the events and considerations resulting in the initiation by the National Cancer Institute (NCI) and the National Surgical Adjuvant Breast and Bowel Project (NSABP) of the B-06 trial of breast-preserving surgery for breast cancer. The B-06 trial is a three-arm trial comparing the relative efficacy of total mastectomy vs. segmental mastectomy (lumpectomy) with and without radiation as treatment for stages I and II breast cancer. This Note largely details the period from 1975-1977, when the protocol was being designed and considered. The literature pertinent to the B-06 trial and interviews with individuals involved in the initiation decision and in operations of the NCI and NSABP describe several influences germane to the initiation of the trial: (1) the progress of the biological and clinical sciences; (2) the funding mechanism and administrative history of the trial and the relationship between NCI and the NSABP; (3) influential individuals; (4) the concerns of participating physicians and ethical issues pertinent to the trial; and (5) the potential effect of the trial on physicians' practices and patients' behavior.