Dana-Farber/Harvard Cancer Center has a proven track record of success in designing, conducting and completing high-impact early phase clinical trials (Pilot, Phase I, Phase I/II). The development and conduct of such trials, which have the potential to transform the care of cancer patients, are challenged by the availability of funds rather than the lack of patients or novel concepts, particularly concepts arising from DF/HCC laboratories. Early Phase Clinical Research Support (EPCRS) funds are used to support research nursing and clinical research coordinator time for approved early phase trials as well as costs associated with the generation of preliminary data through other early phase clinically related activities. Preliminary data may come from pharmacodynamic studies (e.g. measurements of immune perturbation, repeat tumor biopsies, target protein levels, circulating tumor cells or DNA) for important unfunded or under-funded Early Phase trials, with a focus on facilitating the translation of new treatment or biomarker concepts from the laboratory to clinic. By supporting collaborations between laboratory and clinical investigators, EPCRS decreases time from discovery to clinical testing of new agents and approaches thus enabling the conduct of trials that might otherwise either not be conducted or else delayed.
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