Continual reassessment and related designs in dose-finding studies

Abstract

The workshop on the continual reassessment method and related Phase I designs for dose-finding studies was held at Memorial Sloan Kettering Cancer Center in New York on October 2nd, 2009. The workshop was the result of several discussions between Alexia Iasonos and John O'Quigley. These discussions centered around the methodological advancements in Phase I designs with a particular focus on the continual reassessment method (CRM). The participants of the workshop included applied statisticians who have practical experience in using the CRM in clinical trials, an experience gained both in academic and cancer centers, as well as in the pharmaceutical industry in the United States, Japan and Europe. The majority of the participants have participated in Institutional Review Boards and have been involved in discussions with the FDA and European Medicines Agency. One goal of the workshop was to provide a forum to share the lessons learned from finished trials and to discuss the operational and logistical issues, as well as, methodological advancements in adaptive Phase I clinical trial design.