The overall goal of the Clinical Trials Office (CTO) is to provide central management, research support and oversight functions for coordinating, facilitating and conducting human research and reporting results in conjunction with members of the Yale Cancer Center (YCC). The CTO provides a broad range of management and quality control functions, including trial activation and monitoring, centralized protocol document directory, a centralized database of protocol-specific data, data and safety reporting, and assistance with complex regulatory issues. The CTO further provides high quality services involving assistance with patient enrollment, screening, obtaining informed consent and safety reporting. Specific objectives are to: 1. Facilitate timely institutional approval and implementation of clinical trials and translational research; 2. Ensure the research team is adequately trained, qualified and prepared to support each trial; 3. Maintain a centralized web-based repository of all protocol specific documents and consents; 4. Provide clinical assistance and facilitate the conduct of clinical trials (institutional and multi-center) via centralized clinical trial operations, including but not limited to enrollment and verification of patient eligibility, scheduling of appropriate tests, treatments, and assessment; 5. Verify trial data and provide electronic data capture and data management; 6. Insure that all reports, including reports of serious adverse events and unanticipated problems, are , submitted in accordance with institutional and federal regulatory guidelines to appropriate regulatory bodies, including local and central IRBs and sponsors;and 7. Insure protocol compliance with all institutional policies and agreements, state and federal regulations, data accuracy and data integrity through a system of monitoring and quality assurance that is consistent with the YCC Data and Safety Monitoring Plan (DSMP). 8. Carry out the research priorities and functions as determined by the YCC leadership and PRMS committees. The activity and usage of the CTO parallels the growth of the center. As the number of YCC investigators has increased with the number of oncology faculty, the usage of the CTO has increased. For example, in the year (2005) preceding the previous grant submission, 143 patients had been enrolled onto therapeutic trials. In the five years preceding this grant submission 1531 patients have been enrolled onto therapeutic trials, with 471 accrued in the most recent fiscal year (FY12). A number of efficiencies have allowed CTO to maintain quality services and increase in the number of staff. With the rapid expansion of staff to meet the demands, the CTO provides high quality services to the YCC investigators, allowing protocol compliance and conduct consistent with excellence in clinical research.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016359-35
Application #
8755642
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
35
Fiscal Year
2014
Total Cost
$238,882
Indirect Cost
$95,409
Name
Yale University
Department
Type
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Wimberly, Hallie; Brown, Jason R; Schalper, Kurt et al. (2015) PD-L1 Expression Correlates with Tumor-Infiltrating Lymphocytes and Response to Neoadjuvant Chemotherapy in Breast Cancer. Cancer Immunol Res 3:326-32
Ma, Xiaomei; Wang, Rong; Long, Jessica B et al. (2014) The cost implications of prostate cancer screening in the Medicare population. Cancer 120:96-102
Herbst, Roy S; Soria, Jean-Charles; Kowanetz, Marcin et al. (2014) Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515:563-7
Durazzo, Tyler S; Tigelaar, Robert E; Filler, Renata et al. (2014) Induction of monocyte-to-dendritic cell maturation by extracorporeal photochemotherapy: initiation via direct platelet signaling. Transfus Apher Sci 50:370-8
Black, Jonathan D; English, Diana P; Roque, Dana M et al. (2014) Targeted therapy in uterine serous carcinoma: an aggressive variant of endometrial cancer. Womens Health (Lond Engl) 10:45-57
Smith, Matthew R; Halabi, Susan; Ryan, Charles J et al. (2014) Randomized controlled trial of early zoledronic acid in men with castration-sensitive prostate cancer and bone metastases: results of CALGB 90202 (alliance). J Clin Oncol 32:1143-50
Cao, Jian; Liu, Zongzhi; Cheung, William K C et al. (2014) Histone demethylase RBP2 is critical for breast cancer progression and metastasis. Cell Rep 6:868-77
Gonzalez, A L; Berger, C L; Remington, J et al. (2014) Integrin-driven monocyte to dendritic cell conversion in modified extracorporeal photochemotherapy. Clin Exp Immunol 175:449-57
O'Malley, Stephanie S; Wu, Ran; Mayne, Susan T et al. (2014) Smoking cessation is followed by increases in serum bilirubin, an endogenous antioxidant associated with lower risk of lung cancer and cardiovascular disease. Nicotine Tob Res 16:1145-9
Chen, Lieping (2014) From the guest editor: Tumor site immune modulation therapy. Cancer J 20:254-5

Showing the most recent 10 out of 72 publications