The Clinical Trials Office's (CTO) mission is to support clinical investigators in the development and implementation of clinical research studies at the Moffitt Cancer Center. The infrastructure in place assists the investigators with the following activities: ? Assisting investigators in screening and enrolling patients for clinical studies. ? Providing data management support for clinical studies. ? Assisting the Principal Investigators in the compliant conduct of clinical studies, including assisting in the submission of required regulatory documents, annual reviews and adverse event reporting. ? Providing staff training and education pertaining to clinical studies. ? Coordinating and implementing protocol related orders for study patients. ? Preparing medical and research records for audits. The CTO has seen an average combined accrual to clinical intervention, prevention intervention, and supportive care intervention trials of 2,856 subjects/year for FY's 2006-2010 (an average of 1,176 subjects/year for clinical intervention trials, 780 subjects/year for prevention intervention trials, and 872 subjects/year for supportive care intervention trials). FY 2010 was especially robust, with accruals of 1,287,2,406, and 1,001 subjects to clinical, prevention, and supportive care intervention trials, respectively. The accrual to investigator-initiated trials (external peer reviewed + institutional) for all intervention studies has remained greater than 60% for all 5 years and was 84% in FY 2010. Clearly, these accrual levels, as well as the complexity and increased data collection requirements of current trials, have necessitated growth of the CTO and demand increased efficiency. The CTO operates efficiently for the cost effective management of clinical trials at the Cancer Center. The accrual to all intervention, prevention intervention and supportive care intervention trials continues to increase on a yearly basis. The Core requests CCSG Support of $570,611, which is 13% of its operational budget.

Public Health Relevance

The centralized Clinical Trials Office provides consistent, cost-effective services by qualified research staff to support the large clinical trial portfolio generated by the Phase I program, the disease-based clinical departments (phase 11 and 111 trials), and the cancer prevention and control investigators. The core also provides standardized education and orientation to all core staff and investigators.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA076292-15
Application #
8495992
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-02-01
Budget End
2014-01-31
Support Year
15
Fiscal Year
2013
Total Cost
$305,093
Indirect Cost
$124,028
Name
H. Lee Moffitt Cancer Center & Research Institute
Department
Type
DUNS #
139301956
City
Tampa
State
FL
Country
United States
Zip Code
33612
Davis, Stacy N; Govindaraju, Swapamthi; Jackson, Brittany et al. (2018) Recruitment Techniques and Strategies in a Community-Based Colorectal Cancer Screening Study of Men and Women of African Ancestry. Nurs Res 67:212-221
Martínez, Úrsula; Brandon, Thomas H; Sutton, Steven K et al. (2018) Associations between the smoking-relatedness of a cancer type, cessation attitudes and beliefs, and future abstinence among recent quitters. Psychooncology 27:2104-2110
Perales-Puchalt, Alfredo; Perez-Sanz, Jairo; Payne, Kyle K et al. (2018) Frontline Science: Microbiota reconstitution restores intestinal integrity after cisplatin therapy. J Leukoc Biol 103:799-805
Nelson, Ashley M; Jim, Heather S L; Small, Brent J et al. (2018) Sleep disruption among cancer patients following autologous hematopoietic cell transplantation. Bone Marrow Transplant 53:307-314
Singh, Kshipra; Coburn, Lori A; Asim, Mohammad et al. (2018) Ornithine Decarboxylase in Macrophages Exacerbates Colitis and Promotes Colitis-Associated Colon Carcinogenesis by Impairing M1 Immune Responses. Cancer Res 78:4303-4315
Kasting, Monica L; Giuliano, Anna R; Reich, Richard R et al. (2018) Hepatitis C Virus Screening Trends: Serial Cross-Sectional Analysis of the National Health Interview Survey Population, 2013-2015. Cancer Epidemiol Biomarkers Prev 27:503-513
Denson, Aaron; Burke, Nancy; Wapinsky, Georgine et al. (2018) Clinical Outcomes of Patients With Gastrointestinal Malignancies Participating in Phase I Clinical Trials. Am J Clin Oncol 41:133-139
Betts, Brian C; Bastian, David; Iamsawat, Supinya et al. (2018) Targeting JAK2 reduces GVHD and xenograft rejection through regulation of T cell differentiation. Proc Natl Acad Sci U S A 115:1582-1587
Pidala, Joseph; Beato, Francisca; Kim, Jongphil et al. (2018) In vivo IL-12/IL-23p40 neutralization blocks Th1/Th17 response after allogeneic hematopoietic cell transplantation. Haematologica 103:531-539
Hampras, S S; Tommasino, M; Zhao, Y et al. (2018) Cross-sectional associations between cutaneous viral infections and regulatory T lymphocytes in circulation. Br J Dermatol :

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