American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Statement Regarding Clinical Trials

Recent revelations concerning violations in patient-entry criteria for protocol B-06 of the National Surgical Adjuvant Breast and Bowel Project (NSABP) have produced a cascading series of critical responses from various groups that could threaten the future of clinical trials. In light of these developments, patients with recently diagnosed or previously treated breast cancer may be uncertain and apprehensive about the appropriateness of breast conservation treatment. The American College of Surgeons believes that surgeons should reassure their breast cancer patients that the current controversies are not likely to change treatment conclusions. Six other prospective randomized clinical trials from around the world support the initial conclusions reported by the NSABP.

Furthermore, the American College of Surgeons believes that the National Cancer Institute is taking appropriate steps to improve the audit process, and action that is of the utmost importance and in the best interests of all breast cancer patients. The College strongly supports the position that progress in breast cancer control and in many other diseases depends significantly on clinical trials being conducted. One positive outcome of these current controversies could be improved quality control in all clinical trials—a reassuring development for surgeons and their patients.


Reprinted from Bulletin of the American College of Surgeons 
Vol. 79, No. 5, Page 29, May 1994