Abstract

International investigator-driven clinical trials: challenges and opportunities for US - Europe cooperation through the US cooperative group networks

Author(s): Denis Lacombe, Anastassia Negrouk, John Bean

International investigator-driven clinical trials (IDCTs) satisfy international standards for quality, achieve maximum efficiency, avoid duplication of effort, and realize effective and widespread implementation of research results into medical practice. This article focuses on specific intercontinental issues involving the development and conduct of IDCTs and reviews what is necessary for a successful international partnership, specifically, intergroup trials involving the European Organisation for Research and Treatment of Cancer (EORTC) and the US-based National Cancer Institute intergroup system. Through examples, it is shown that the lead group of an international intergroup IDCT must have the expertise and capabilities to work effectively in the international setting, establish working procedures, consider the regulatory environment and QA/QC in the trial setting, and secure the principles of academic independence.