Clinical trials in ovarian carcinoma: requirements for standard approaches and regimens.

The 3rd International Ovarian Cancer Consensus Conference (OCCC), held 3–5 September 2004, in Baden-Baden, Germany, addressed 12 questions critical to the future directions of clinical research into the treatment of newly diagnosed ovarian cancer. Four of these questions examined issues related to the current standard of care and to what should, for now, constitute a proper control arm in future phase III clinical trials. These questions are listed in Table 1. Consensus on the answer to these four questions is crucial to the interpretation of major clinical trials. Such a consensus will encourage the use of similar standards in each major trial and thus will provide a common basis for interpretation. This article will provide a detailed discussion of the rationale for the unanimous consensus achieved for each of these four questions.