Abstract

Methodology for the Development of Innovative Cancer Therapies Task Force addresses methodological issues in the clinical development of innovative cancer therapies

Author(s): Marinus W Lobbezoo, A Hilary Calvert, Elizabeth A Eisenhauer,Giuseppe Giaccone

The Task Force on Methodology for the Development of Innovative Cancer Therapies is an expert forum established to discuss methodological issues in the early clinical development of new molecular-targeted cancer therapeutics. This paper describes the mission, structure and organization of the Task Force and its achievements thus far. Experts from academia, industry and regulatory agencies participate in Task Force meetings and discussions. Since it was established in 2006, the Task Force has met annually and has published recommendations on various design aspects of early-phase cancer clinical trials as well as on decision criteria to continue development from preclinical to Phase I and from Phase I to Phase II studies.