The Clinical Trials Core will support all investigators in the Dana-Farber/Harvard SPORE in Breast Cancer conducting clinical trials. The Clinical Trials Core will coordinate preparation, review and activation of clinical studies developed within the SPORE and Inter-SPORE programs. Additionally, the Clinical Trials Core will facilitate recruitment and consent of patients, clinical management and follow-up of patients, data collection and management and real-time monitoring of accrual and toxicity once trials are open. The Core will work closely with other SPORE Cores to coordinate all aspects of clinical research, including biostatistics support and biospecimen collection. The Core will utilize the Dana-Farber/Harvard Cancer Center data management infrastructure to facilitate the multi-center trials. The Core has resources available to achieve the aims outlined in the proposal, including dedicated Co-Directors, institutional commitment of clinical research coordinators and research nurses from all the institutions participating in clinical trials in the SPORE.

Public Health Relevance

The Clinical Trials Core centralizes support for SPORE investigators initiating clinical trials to increase efficiency, minimize delays and revisions, and maximize our ability to complete clinical trials in the SPORE. Streamlining the clinical trials process assures that clinical studies in the SPORE are conducted expeditiously and with the highest degree of scientific rigor, enhancing the likelihood they will provide translational results.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Specialized Center (P50)
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Special Emphasis Panel (ZCA1-RPRB-0)
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Dana-Farber Cancer Institute
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