title: Infrastructure needs for translational integration of mouse and human trials.
abstract: Advances in the treatment of human cancer are frequently limited by the inability to test novel drugs and drug combinations in patients in a rapid and streamlined manner. Increasing data from the application of clinically relevant mouse models has highlighted the ability of preclinical trials in mice to address this problem, and has paved the way for what is now termed the "Co-Clinical Trial Project," in which mouse trials are performed concurrently with human trials. This in turn enables efficient patient stratification and therapy optimization based on molecular determinants for effective treatment of cancer. To fully realize the potential of preclinical, coclinical, and postclinical trials in mice, there is a need to establish key principles for carrying out therapeutic mouse trials, to standardize practices for performing such trials, and to establish mouse hospitals where trials can be integrated with corresponding clinical trial efforts in humans. Here we describe critical infrastructural components that are required for effective implementation of such efforts and suggest a model for how mouse hospitals for clinical trials should be established.
authors.affiliation: Preclinical Murine Pharmacogenetics Facility, Division of Genetics, Department of Medicine, Beth Israel Deaconess Cancer Center, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Harvard Medical School, Boston, Massachusetts 02215;
authors.forename: John G
authors.initials: JG
authors.lastname: Clohessy
authors.forename: Elisa
authors.initials: E
authors.lastname: de Stanchina
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000302:isolation & purification / Q000494:pharmacology* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D019295:Computational Biology / Q000379:methods*; D016208:Databases, Factual; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D006801:Humans; D051379:Mice; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents