Clinical Protocol & Data Management (CPDM) functions at Moffitt Cancer Center (MCC) include 1) trial design, development, and conduct; 2) oversight of safety and compliance; 3) ensuring data quality and education of personnel; and 4) appropriate accrual of women and minorities. A collaborative team of approximately 190 CPDM professionals provides centralized management and support of all types of clinical trials, including investigator-initiated (IITs), industry or other sponsor-initiated, Experimental Therapeutics Clinical Trials Network (ET-CTN), and National Clinical Trials Network (NCTN). CPDM support for members includes: protocol development; budget development and contracting; regulatory and IND/IDE management; protocol activation; patient enrollment; coordination of study-related patient care; research drug administration and care services; correlative science (pharmacokinetics/pharmacodynamics) sample coordination; data collection and reporting; monitoring of IIT studies and data and safety monitoring through the Protocol Monitoring Committee (PMC) and Data Safety & Monitoring (DSM) Committee; audit preparation and coordination; minority outreach and navigation for accrual to clinical trials; clinical trials management system (CTMS, OnCore) administration and reporting; staff workload management; and staff education and training. During the review period (FY2011-2015), the CPDM team successfully accrued and coordinated a combined total of 11,851 patients to clinical interventional trials (therapeutic, prevention, and supportive care), including accrual at affiliate sites. CPDM provides centralized safety and compliance oversight to members through timely monitoring of investigator-initiated interventional trials, coordination of the PMC, and corporate compliance audits of MCC clinical research trials, policies, and processes. Results of monitoring and audits are utilized by the PMC for comprehensive review. MCC has developed and maintains proactive efforts to provide programs and services to women, minorities, and other underserved populations through culturally and linguistically relevant care, education, and internal and community outreach. Faculty members conduct research on minority health disparities, informing these programs and services. In addition, the ACD for Clinical Science and the VP of Diversity and Community Relations co-lead a multi-disciplinary Minority Clinical Research Committee to address issues related to minority accrual at MCC. CPDM resources are closely integrated in these efforts.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA076292-21
Application #
9637359
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2019-02-01
Budget End
2020-01-31
Support Year
21
Fiscal Year
2019
Total Cost
Indirect Cost
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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