The Data and Safety Monitoring Plan, adopted by the H. Lee Moffitt Cancer Center and Research Institute originally in 2002 and revised repeatedly throughout the grant period, ensures that all clinical research conducted or coordinated by the Cancer Center is scientifically well designed, responsibly managed, appropriately reported, and that it protects the rights and welfare of human participants. The institutional plan conforms to NIH and NCI policies and guidelines regarding data and safety monitoring. The methodology and amount of monitoring required are dictated by the degree of risk involved to the individual patients and the complexity of the clinical research. Because the specific types of monitoring and reporting needed vary by the nature of the individual trial, the responsibility for ensuring that monitoring is appropriate, timely, and effective encompasses a number of Cancer Center individuals and groups. The Associate Center Director for Clinical Investigations has overall responsibility for data and safety monitoring, and the Protocol Monitoring Committee (PMC) is the Institution's venue for review of all monitoring reports. The PMC has a separate and distinct function from the Scientific Review Committee and the IRB. Its primary tasks are to: ? Assess safety by reviewing severe adverse event reports from investigator-initiated studies and monitor their timely and appropriate reports to oversight agencies (such as the IRB, FDA, or NCI). ? Review audits of investigator-initiated clinical trials ? Review interim data and safety reports from investigator-initiated studies ? Review the interim and final reports from the external Data Safety and Monitoring Board The Protocol Monitoring Committee (PMC), chaired by Scott Antonia, MD, PhD, includes members from a variety of the Cancer Center's clinical and scientific programs who have extensive experience with clinical research. The DSM requests CCSG Support of $72,617 for support of Protocol Monitoring Committee activities.
Data and Safety Monitoring at Moffitt provides a level of monitoring during clinical trials that is necessary to protect the safety of human subjects and to ensure the validity and scientific integrity of clinical trial data.
|Reed, Damon R; Mascarenhas, Leo; Manning, Kathleen et al. (2016) Pediatric phase I trial of oral sorafenib and topotecan in refractory or recurrent pediatric solid malignancies. Cancer Med 5:294-303|
|Permuth, Jennifer B; Pirie, Ailith; Ann Chen, Y et al. (2016) Exome genotyping arrays to identify rare and low frequency variants associated with epithelial ovarian cancer risk. Hum Mol Genet 25:3600-3612|
|Weber, Jeffrey; Gibney, Geoffrey; Kudchadkar, Ragini et al. (2016) Phase I/II Study of Metastatic Melanoma Patients Treated with Nivolumab Who Had Progressed after Ipilimumab. Cancer Immunol Res 4:345-53|
|Schabath, Matthew B; Massion, Pierre P; Thompson, Zachary J et al. (2016) Differences in Patient Outcomes of Prevalence, Interval, and Screen-Detected Lung Cancers in the CT Arm of the National Lung Screening Trial. PLoS One 11:e0159880|
|Turner, Joel G; Dawson, Jana L; Grant, Steven et al. (2016) Treatment of acquired drug resistance in multiple myeloma by combination therapy with XPO1 and topoisomerase II inhibitors. J Hematol Oncol 9:73|
|Haake, Scott M; Li, Jiannong; Bai, Yun et al. (2016) Tyrosine Kinase Signaling in Clear Cell and Papillary Renal Cell Carcinoma Revealed by Mass Spectrometry-Based Phosphotyrosine Proteomics. Clin Cancer Res :|
|Extermann, Martine; Leeuwenburgh, Christiaan; Samiian, Laila et al. (2016) Impact of chemotherapy on medium-term physical function and activity of older breast cancer survivors, and associated biomarkers. J Geriatr Oncol :|
|Jiang, Kun; Neill, Kevin; Cowden, Daniel et al. (2016) Expression of CAS/CSE1L, the Cellular Apoptosis Susceptibility Protein, Correlates With Neoplastic Progression in Barrett's Esophagus. Appl Immunohistochem Mol Morphol :|
|Kim, Jae-Young; Welsh, Eric A; Fang, Bin et al. (2016) Phosphoproteomics Reveals MAPK Inhibitors Enhance MET- and EGFR-Driven AKT Signaling in KRAS-Mutant Lung Cancer. Mol Cancer Res 14:1019-1029|
|Robinson, Lary A; Jaing, Crystal J; Pierce Campbell, Christine et al. (2016) Molecular evidence of viral DNA in non-small cell lung cancer and non-neoplastic lung. Br J Cancer 115:497-504|
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