The core intellectual foundation of this application rests on a very simple and yet very novel idea not yet developed and implemented in any center in the world which we term for brevity "the Co-Clinical Project". The past years have seen tremendous advances in technology that have allowed us to gain powerful insight into the molecular and genetic determinants that drive cancer. However, by comparison, the rate at which this advanced knowledge has been translated into effective therapeutics is pitifully slow. In order to fill this void we have come up with "The Co-Clinical Project" idea. The "Co-Clinical Project" stems from the realization of the tremendous power of preclinical testing of new drugs, novel drug combinations and novel therapeutic modalities in mouse models of human cancer. In a nut-shell, what we propose with the "Co-Clinical Project" is that each clinical trial at the participating Institutions will be run "in parallel" with pre-clinical trials in appropriate, faithful and genetically relevant mouse models, and that the clinical, biological and pharmacological information (i.e. somatic mutational background, germline single nucleotide polymorphism (SNP) variations, responsiveness to specific regimens;imaging, microarray and proteomics profiles) will be accrued, analyzed in parallel and integrated in order to facilitate the identification of biomarkers that predict response to specific treatments. These studies will ultimately bring the advances in technology and our understanding of cancer to a strong translational forum, rapidly leading to patient stratification criteria based on molecular and genetic information. We describe here how this "Leadership team" envisions the factual realization of this exciting and ambitious endeavor.

Public Health Relevance

This application will have a defining impact on how cancer clinical trials are designed and carried out. The development of the "Co-Clinical Trial" Project will put in place a blue print for the rapid development and subsequent translation of novel cancer therapies from bench to bedside, enabling a more coordinated and rational effort between basic research and clinical scientists towards the eradication of cancer.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZCA1-SRLB-Q (M1))
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Marks, Cheryl L
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Beth Israel Deaconess Medical Center
United States
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