[ST-17] Statement Regarding Clinical Trials
[by the American College of Surgeons]
The American College of Surgeons recognizes that important
advances in the understanding and treatment of many diseases
have occurred over the past decades as a result of information
obtained in large clinical trials. The College also recognizes
the inherent difficulties of attempting to monitor the conduct
of clinical trials involving large numbers of geographically
dispersed research centers. The importance of such clinical trials
is so valuable in clinical decision making that they must be
considered a part of any clinical research armamentarium. For
several years, the American College of Surgeons has been a cosponsor
of the National Cancer Data Base of the Commission on Cancer,
which has tracked treatment trends of patients with many forms
of cancer. For instance, retrospective studies of breast cancer
patients have already demonstrated a significant shift from standard
radical mastectomy to more conservative procedures.
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.
Statements
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Reprinted from Bulletin of the American College
of Surgeons
Vol. 79, No. 5, Page 29, May 1994
