Early Phase Clinical Research Support

University Of California, San Diego, La Jolla CA

Investigators

Linked publications & trials

Abstract

Early Phase Clinical Research Support. Definitive testing of the value of novel therapeutics and diagnostics in large randomized trials requires the prior execution of early phase trials that provide the information needed to design pivotal studies. Phase 1 trials are directed at determining doses of drug that are appropriate for subsequent trials and the pattern of adverse events produced. Feasibility and pilot trials are conducted to obtain preliminary information on the tolerability of particular drug combinations, the ability to measure effects on drug targets, or to assess whether a particular biomarker or imaging technology can assist in predicting or assessing response. Our emphasis has been on innovative technology discovered in MCC labs as well as translating basic biological discoveries in MCC labs into clinical trials that benefit patients. In calendar year 2012, 145 patients accrued to 48 interventional treatment studies in Early Phase Therapeutics. An emphasis on genomic profiling and targeted therapy is now emerging, and will be fundamental to future trials. In the future, there will be a focus on and significant expansion of the development and clinical testing of new agents, matching agents with patients based on molecular profile, bringing drugs discovered at MCC into phase I testing, and expansion of the depth and breadth of academic and industry partnerships.