Why clinical trials?

Abstract

II setting any effect of the new therapy is studied. Finally in phase III studies by randomization, a new idea is compared with standard therapy. Phase I and II studies might be described as pilot studies or feasibility and toxicity studies. For new surgical approaches we need carefully designed prospective studies to convincingly show that a new technique is better than the standard procedure. Oncology is multidisciplinary and in discussing both completed and ongoing studies we shall focus specifically on questions which are of major interest to surgeons. There are many organizations in Europe which deal with trials. Some trials are single institution investigations but most are multicentre studies. Since the trial section is designed to increase awareness and encourage the participation in trials we shall emphasize those studies which are open for general participation. We shall concentrate on European studies but important results from major trial groups, such as the NSABP, will be included. In Europe several large trial organizations exist, many on a national basis. Sometimes regional cooperation leads to effective running of prospective studies. The EORTC (European Organization for the Research and Treatment of Cancer) and the UKCCCR (United Kingdom Committee for Coordination of Cancer Research) are important groups responsible for organizing prospective randomized studies. In the following article the EORTC president, Professor Gordon MoVie, gives his views on why trials are necessary. Hopefully our surgical readers will consider accruing patients in these studies and thereby help to solve the many open questions.