The purpose of the Protocol Review and Monitoring System (PRMS) is to review the scientific merit, scientific priorities, and scientific progress of cancer-related studies that are conducted at the University of Chicago, regardless of sponsor, department or type, and that use the University of Chicago Comprehensive Cancer Center (UCCCC) resources. The UCCCC PRMS is divided into two committees, the Clinical Trials Review Committee (CTRC), and the Scientific and Accrual Monitoring (SAM) Committee, which are overseen by the Associate Director for Clinical Sciences (Dr. Mark Ratain) and the Clinical Research Advisory Committee (CRAC). A single Coordinator serves all three committees. The CTRC and SAM are composed of UCCCC members from all academic units and disciplines who have expertise in clinical trials. The CTRC meets monthly, and has primary responsibility for evaluation of the scientific merit, rigor, appropriateness of data and safety monitoring, and the relative prioritization of trials in the context of UCCCC and disease-specific program goals and resources. CTRC and IRB review occur simultaneously, but protocol activation requires full CTRC approval. CTRC reviews are conducted by at least 3 individuals, including a biostatistician. Protocols may be approved, approved with revisions, deferred, or disapproved. Protocols that have undergone prior peer review (e.g., cooperative group protocols, NIH, ACS) and strict banking/registry studies are eligible for expedited review;that is, they are not required to be reviewed by the full committee, but rather will be reviewed by the Chair or Co-chair who have the option of bringing them to the full committee if there are specific concerns (e.g., design, prioritization). In addition, CTRC has the authority to close protocols based on the recommendation of the SAM Committee. Specifically, the SAM Committee has primary responsibility for monitoring the scientific progress of CTRC-approved studies including accrual, minority accrual, and overall progress towards meeting the study's objectives, as well as ensuring adherence to protocol procedures and UCCCC Data and Safety Monitoring requirements. The SAM Committee meets monthly, and recommends closure of protocols that are not making adequate scientific progress, or that are not meeting adequate scientific or Data and Safety Monitoring guidelines.
The PRMS serves an important role In the UCCCC's clinical research infrastructure. Through initial and ongoing review of cancer-related trials, the PRMS ensures that all cancer-related studies conducted at the UCCCC are scientifically sound, are conducted according to ethical standards, have appropriate data and safety monitoring and use institutional resources appropriately.
|Trujillo, Jonathan A; Sweis, Randy F; Bao, Riyue et al. (2018) T Cell-Inflamed versus Non-T Cell-Inflamed Tumors: A Conceptual Framework for Cancer Immunotherapy Drug Development and Combination Therapy Selection. Cancer Immunol Res 6:990-1000|
|Zeng, Zongyue; Huang, Bo; Huang, Shifeng et al. (2018) The development of a sensitive fluorescent protein-based transcript reporter for high throughput screening of negative modulators of lncRNAs. Genes Dis 5:62-74|
|Lee, Ji-Hye; Park, Beom Seok; Han, Kang R et al. (2018) Insight Into the Interaction Between RNA Polymerase and VPg for Murine Norovirus Replication. Front Microbiol 9:1466|
|Cheng, Jason X; Chen, Li; Li, Yuan et al. (2018) RNA cytosine methylation and methyltransferases mediate chromatin organization and 5-azacytidine response and resistance in leukaemia. Nat Commun 9:1163|
|Johnson, Marianna B; Hoffmann, Joscelyn N; You, Hannah M et al. (2018) Psychosocial Stress Exposure Disrupts Mammary Gland Development. J Mammary Gland Biol Neoplasia 23:59-73|
|Sweis, Randy F; Zha, Yuanyuan; Pass, Lomax et al. (2018) Pseudoprogression manifesting as recurrent ascites with anti-PD-1 immunotherapy in urothelial bladder cancer. J Immunother Cancer 6:24|
|Kathayat, Rahul S; Cao, Yang; Elvira, Pablo D et al. (2018) Active and dynamic mitochondrial S-depalmitoylation revealed by targeted fluorescent probes. Nat Commun 9:334|
|Liu, Jun; Eckert, Mark A; Harada, Bryan T et al. (2018) m6A mRNA methylation regulates AKT activity to promote the proliferation and tumorigenicity of endometrial cancer. Nat Cell Biol 20:1074-1083|
|Bhanvadia, Raj R; VanOpstall, Calvin; Brechka, Hannah et al. (2018) MEIS1 and MEIS2 Expression and Prostate Cancer Progression: A Role For HOXB13 Binding Partners in Metastatic Disease. Clin Cancer Res 24:3668-3680|
|Wood, Kevin; Byron, Elizabeth; Janisch, Linda et al. (2018) Capecitabine and Celecoxib as a Promising Therapy for Thymic Neoplasms. Am J Clin Oncol 41:963-966|
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