Clinical trials of the treatment of breast cancer in Britain and Ireland. Report by co-ordinating committee.

Abstract

Thirteen trials of systemic chemotherapy in early breast cancer were identified and protocols obtained. The differences in the latter prevented a true comparison of the results. In setting up any trial it is important to define the primary objectives and to include a statistician from the start. Only truly random allocation of patients is acceptable, while treatment programmes must be fully monitored. Other important aspects include review of the results by an independent member of the trial committee and keeping full, but simple, case records. Though any trial must be designed by a committee and not a single investigator, the individual clinician remains responsible for the patients under his care. To launch a controlled randomised trial without full preparation and guaranteed resources is in the best interests of neither patients nor doctors.