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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Sen, Supriya; Langiewicz, Magda; Jumaa, Hassan et al. (2015) Deletion of serine/arginine-rich splicing factor 3 in hepatocytes predisposes to hepatocellular carcinoma in mice. Hepatology 61:171-83
Hoffmann, Hanne M; Tamrazian, Anika; Xie, Huimin et al. (2014) Heterozygous deletion of ventral anterior homeobox (vax1) causes subfertility in mice. Endocrinology 155:4043-53
Hartman, Lisa L R; Crawford, John R; Makale, Milan T et al. (2014) Pediatric phase II trials of poly-ICLC in the management of newly diagnosed and recurrent brain tumors. J Pediatr Hematol Oncol 36:451-7
Williams, Richard T; Barnhill, Lisa M; Kuo, Huan-Hsien et al. (2014) Chimeras of p14ARF and p16: functional hybrids with the ability to arrest growth. PLoS One 9:e88219
Huang, Carlos P; Fofana, Mariama; Chan, Jefferson et al. (2014) Copper transporter 2 regulates intracellular copper and sensitivity to cisplatin. Metallomics 6:654-61
Paolini, Paul; Pick, Daniel; Lapira, Jennifer et al. (2014) Developmental and extracellular matrix-remodeling processes in rosiglitazone-exposed neonatal rat cardiomyocytes. Pharmacogenomics 15:759-74
Goellner, Eva M; Smith, Catherine E; Campbell, Christopher S et al. (2014) PCNA and Msh2-Msh6 activate an Mlh1-Pms1 endonuclease pathway required for Exo1-independent mismatch repair. Mol Cell 55:291-304
Glidewell-Kenney, Christine A; Trang, Crystal; Shao, Paul P et al. (2014) Neurokinin B induces c-fos transcription via protein kinase C and activation of serum response factor and Elk-1 in immortalized GnRH neurons. Endocrinology 155:3909-19
Jiang, P; Mukthavaram, R; Chao, Y et al. (2014) In vitro and in vivo anticancer effects of mevalonate pathway modulation on human cancer cells. Br J Cancer 111:1562-71
Jacques, Bonnie E; Montgomery 4th, William H; Uribe, Phillip M et al. (2014) The role of Wnt/*-catenin signaling in proliferation and regeneration of the developing basilar papilla and lateral line. Dev Neurobiol 74:438-56

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