Clinical Trials Office The Clinical Trials Office (CTO) provides a centralized service to support the development and execution of clinical trials in all of the Center's defined Research Programs. The CTO oversees all trials from a variety of venues and sponsors, including pharmaceutical, local institutional trials, and cooperative group trials. It has oversight of trials from a diverse group of medical specialties including, but not limited to, medical oncology, radiation oncology, surgery, hematology oncology, gynecologic oncology, palliative care, supportive care, and basic science. This includes protocol preparation, data acquisition, safety monitoring and reporting, quality assurance, regulatory compliance, overall study management and personnel training. The CTO serves the overall clinical research needs of investigators in protocol development and activation, and its staff is integral to the clinical care provided throughout the clinical trial continuum. The CTO is intentionally structured to operate with efficiency, to focus on the quality of clinical data collected, and to facilitate timely activation of and accrual to therapeutic trials. Sustained success has been demonstrated in all 3 categories. Targeted efforts are ongoing in order to reduce the number of low accruing clinical trials and to increase the number of investigator-initiated therapeutic clinical trials and accrual to those trials. Since the last review, considerable efforts have been made to centralize clinical and protocol data management activities by integrating the hematologic malignancies within the clinical trials office. The clinical trials office is currently implementing a new clinical trial management system (Velos) in collaboration with the Clinical Translational Research Institute (CTRI) (the CTRI leverages CTSA grant support), which will provide more robust protocol management and patient accrual reporting capabilities. Additionally, a protocol development manager and regulatory specialist have been recruited to assist with the conduct of the center's investigator-initiated trials. An important focus for new trials will be molecular profiling and individualization of therapy, which will be implemented within clinical trials with CTO staff support.

Public Health Relevance

The availability of the Clinical Trials Office enables our researchers to properly design and conduct clinical trials. Clinical trials are critical to the successful development and regulatory approval of new cancer treatments and diagnostic tools.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
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Subcommittee G - Education (NCI)
Program Officer
Shafik, Hasnaa
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University of California San Diego
La Jolla
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