Phase II trials in the EORTC. The Protocol Review Committee, the Data Center, the Research and Treatment Division, and the New Drug Development Office. European Organization for Research and Treatment of Cancer

Abstract

The Protocol Review Committee (PRC) has prepared this document in order to clarify the phases of introduction of a new therapeutic agent in the treatment of cancer. Our aim is to define these phases and to make explicit the intentions which lie behind EORTC studies at each stage in the process. The PRC hopes that this will help the Cooperative Groups of the EORTC in developing their protocols for clinical trials carried out under the auspices of the EORTC. This position paper may also assist those undertaking this form of clinical research outside the EORTC.