Organization and ethical aspects of randomized trials in gynecologic oncology

Randomized trials remain often the most reliable method for evaluating the efficacy of therapies in Gynaecological Oncology. However, a trial can only be ethical acceptable if well conceived and well executed. One of the most important ethical issues in randomized trials is the informed consent. Patients must always be aware that they are part of an experiment and give voluntary informed consent. Only in very rare occasions an informed consent might be omitted (e.g. after agreement of a National Ethical Committee). Each randomized trial must have a good chance of settling an open question. The measures of outcome, should be carefully stated in the protocol. Each new protocol should be reviewed on at least 4 levels: by competent colleagues, an Ethical Review Board, a panel of scientists and the well-informed patient. Every randomized trial should be published in a peer reviewed medical journal, also when the results are negative or when the trial is stopped during accrual. Interim analyses of randomized trials result often in incorrect conclusions. These interim analyses should always be carefully planned and interpreted by an independent data-monitoring committee. International cooperative groups, such as the EORTC, often are the only organizations to perform large phase-III randomized trials. The creation of a Gynaecological Cancer Intergroup (GCIG) will increase the cooperation between the different international groups.