Therapeutic cancer vaccines are a heterogeneous group of complex biologics with distinctly different clinical characteristics than cytotoxic agents. The current clinical development paradigm used for oncology drug development is based on criteria developed for cytotoxic agents. More flexible and focused developmental guidelines are needed to address the unique characteristics of therapeutic cancer vaccines. Over the course of 1 year, the Cancer Vaccine Clinical Trial Working Group, representing academia and the pharmaceutical and biotechnology industries with participation from the US Food and Drug Administration, defined in a consensus process the cornerstones of a new clinical development paradigm for cancer vaccines and related biologics. Four major topics were addressed: (1) end points for clinical trials, (2) trial designs and statistical methods, (3) technical and developmental challenges, and (4) combination therapy.Authors: Axel Hoos, Giorgio Parmiani, Kristen Hege, Mario Sznol, Hans Loibner, Alecander Eggermont, Walter Urba, Brent Blumenstein, Natalie Sacks, Ulrich Keilholz and Geoffrey Nichol for the Cancer Vaccine Clinical Trial Working Group (CVCTWG)Published in the Journal of Immunotherapy (2007) 30:1.#SITCPublication