Winship's Protocol Review and Monitoring System (PRMS) requires the review of all proposed cancer clinical trials for scientific quality and merit. The PRMS also calls for the prioritization, monitoring, and termination of protocols based on scientific progress and patient accrual. The Winship Clinical and Translational Review Committee (CTRC) is responsible for these functions. The CTRCs purposes are: 1. To review new proposals for clinical research to ensure that they are scientifically meritorious, that they address significant scientific issues, and that there are sufficient patient and institutional resources to conduct the study as proposed. 2. To prioritize among clinical research proposals within cancer disease sites in order to best fulfill the strategic objectives of the Winship Cancer Institute and of its four research programs. 3. To review the scientific progress of existing clinical research protocols and to terminate protocols in which accrual rates are inconsistent with meeting the stated scientific objective or in which new scientific data renders the trial as having greater safety or efficacy issues or as less scientifically important. 4. To monitor studies for the accuracy and validity of the clinical and laboratory data obtained during the conduct of the clinical study. PRMS is now clearly separated from the Winship Clinical Trials Office (CTO) and the Data Safety and Monitoring Plan (DSMP). In addition, the CTRC has tightened the criteria for new study proposals to achieve scientific review. The changes in criteria include: 1) strict rules regarding the ability of new studies to meet accrual targets, with special attention to any potential eligibility conflict with any ongoing clinical trials, and 2) a requirement that new study proposals address scientific questions relevant to the Winship Cancer Institute's overall scientific goals. The CTRC, under the direction of Thomas Olson, M.D. and Taofeek Owonikoko, Ph.D., M.D expanded to include 24 members and meets on a twice monthly basis to review all proposed cancer clinical trials.
The Protocol Review and Monitoring System (PRMS) ensures that all cancer-related clinical research studies Involving human subjects that are conducted at the Winship Cancer Institute are scientifically evaluated and prioritized.
|Danish, Hasan; Ferris, Matthew J; Balagamwala, Ehsan et al. (2018) Comparative outcomes and toxicities for ruthenium-106 versus palladium-103 in the treatment of choroidal melanoma. Melanoma Res 28:120-125|
|Barwick, Benjamin G; Scharer, Christopher D; Martinez, Ryan J et al. (2018) B cell activation and plasma cell differentiation are inhibited by de novo DNA methylation. Nat Commun 9:1900|
|Liu, Fakeng; Liu, Yuan; Liu, Xiuju et al. (2018) Inhibition of IGF1R enhances 2-deoxyglucose in the treatment of non-small cell lung cancer. Lung Cancer 123:36-43|
|Kennedy, E M; Powell, D R; Li, Z et al. (2018) Galactic Cosmic Radiation Induces Persistent Epigenome Alterations Relevant to Human Lung Cancer. Sci Rep 8:6709|
|Xiao, Canhua; Beitler, Jonathan J; Higgins, Kristin A et al. (2018) Differential regulation of NF-kB and IRF target genes as they relate to fatigue in patients with head and neck cancer. Brain Behav Immun 74:291-295|
|Cassidy, Richard J; Zhang, Xinyan; Switchenko, Jeffrey M et al. (2018) Health care disparities among octogenarians and nonagenarians with stage III lung cancer. Cancer 124:775-784|
|Jhaveri, Jaymin; Chowdhary, Mudit; Zhang, Xinyan et al. (2018) Does size matter? Investigating the optimal planning target volume margin for postoperative stereotactic radiosurgery to resected brain metastases. J Neurosurg :1-7|
|Jhaveri, Jaymin; Rayfield, Lael; Liu, Yuan et al. (2018) Impact of intensity modulated radiation therapy on survival in anal cancer. J Gastrointest Oncol 9:618-630|
|Bilen, Mehmet Asim; Dutcher, Giselle Marie Almeida; Liu, Yuan et al. (2018) Association Between Pretreatment Neutrophil-to-Lymphocyte Ratio and Outcome of Patients With Metastatic Renal-Cell Carcinoma Treated With Nivolumab. Clin Genitourin Cancer 16:e563-e575|
|Chowdhary, Mudit; Switchenko, Jeffrey M; Press, Robert H et al. (2018) Post-treatment neutrophil-to-lymphocyte ratio predicts for overall survival in brain metastases treated with stereotactic radiosurgery. J Neurooncol 139:689-697|
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