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.
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.
|Eroglu, Zeynep; Zaretsky, Jesse M; Hu-Lieskovan, Siwen et al. (2018) High response rate to PD-1 blockade in desmoplastic melanomas. Nature 553:347-350|
|Lu, Yingchang; Beeghly-Fadiel, Alicia; Wu, Lang et al. (2018) A Transcriptome-Wide Association Study Among 97,898 Women to Identify Candidate Susceptibility Genes for Epithelial Ovarian Cancer Risk. Cancer Res 78:5419-5430|
|Phadke, Manali; Remsing Rix, Lily L; Smalley, Inna et al. (2018) Dabrafenib inhibits the growth of BRAF-WT cancers through CDK16 and NEK9 inhibition. Mol Oncol 12:74-88|
|Kasting, Monica L; Christy, Shannon M; Sutton, Steven K et al. (2018) Florida physicians' reported use of AFIX-based strategies for human papillomavirus vaccination. Prev Med 116:143-149|
|Jiang, Kun; Neill, Kevin; Cowden, Daniel et al. (2018) Expression of CAS/CSE1L, the Cellular Apoptosis Susceptibility Protein, Correlates With Neoplastic Progression in Barrett's Esophagus. Appl Immunohistochem Mol Morphol 26:552-556|
|Park, Jae H; Rivière, Isabelle; Gonen, Mithat et al. (2018) Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia. N Engl J Med 378:449-459|
|Pamnani, Shitaldas J; Sudenga, Staci L; Rollison, Dana E et al. (2018) Recurrence of Genital Infections With 9 Human Papillomavirus (HPV) Vaccine Types (6, 11, 16, 18, 31, 33, 45, 52, and 58) Among Men in the HPV Infection in Men (HIM) Study. J Infect Dis 218:1219-1227|
|Poort, Hanneke; Meade, Cathy D; Knoop, Hans et al. (2018) Adapting an Evidence-Based Intervention to Address Targeted Therapy-Related Fatigue in Chronic Myeloid Leukemia Patients. Cancer Nurs 41:E28-E37|
|Cherezov, Dmitry; Hawkins, Samuel H; Goldgof, Dmitry B et al. (2018) Delta radiomic features improve prediction for lung cancer incidence: A nested case-control analysis of the National Lung Screening Trial. Cancer Med 7:6340-6356|
|Simmons, Vani N; Sutton, Steven K; Meltzer, Lauren R et al. (2018) Long-term outcomes from a self-help smoking cessation randomized controlled trial. Psychol Addict Behav 32:710-714|
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