The goals of the Protocol Review and Monitoring System (PRMS) are accomplished by the Clinical Research Committee (CRC) of the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC). CRC reviews all new cancer protocols for scientific merit, methodology, adequacy of human resources, funding, and reasonableness of accrual goals before submission to the Institutional Review Board (IRB) of the University of Maryland School of Medicine at the University of Maryland-Baltimore (UMB). CRC ensures for all institutionally originated protocols that expert biostatistical planning has occurred, and monitors all protocols for early closure if accrual is not proceeding or if scientific or safety issues arise. CRC provides review as needed of Medicare coverage and PI determinations of research versus standard of care procedures. CRC works with disease groups to ensure proper prioritization for effort of proposed versus existing protocols. CRC considers the actual accrual of underserved minorities to UMGCC protocols on a periodic basis with Dr. Shana Ntiri, medical director of the Baltimore City Cancer Program and community outreach liaison for clinical research, to ensure at least congruence with UMGCC's catchment demographic profile. CRC reviews the adequacy of the proposed Data Safety Monitoring (DSM) plan and stipulates the frequency and intensity of review by the DSM/Quality Assurance Committee. During calendar year (CY) 2009, CRC reviewed 61 protocols: 7 were approved as written;42 were approved with minor modifications; 8 were approved with major modifications and required another review;2 were deferred for reconsideration because of issues raised by the review process;and 2 were disapproved. An expedited review process exists for minimal risk non-interventional studies;that process approved nine studies in CY2009. The full CRC does not directly review technology-related protocols without treatment intent from Radiation Oncology. Such reviews are delegated to a specialized subcommittee of CRC, the Technology Research Review Committee. During CY2009, 113 trials were monitored for accrual, targeting for corrective action protocols that were not accruing at a rate suggesting successful completion within a 3- to 5-year time frame. Twenty three warning letters were issued. As of August 2010, CRC had closed eight protocols as a result of this process.
PRMS, as embodied in CRC, is central to the mission of clinical research at UMGCC. PRMS is the arbiter of quality for the research protocols under its purview. It ensures that protocols are being implemented with efficiency and optimal use of human resources in protocol management. As required by UMSOM's IRB, PRMS reviews all institutional protocols that deal with the diagnosis, prevention, treatment, and imaging of cancer?setting the institutional standard of excellence in clinical cancer research across all UMB schools.
|Wang, Lei; Ma, Xiao; Xu, Xiaolei et al. (2017) Systematic identification and characterization of cardiac long intergenic noncoding RNAs in zebrafish. Sci Rep 7:1250|
|Nowak, Rebecca G; Ambulos, Nicholas P; Schumaker, Lisa M et al. (2017) Genotyping of high-risk anal human papillomavirus (HPV): ion torrent-next generation sequencing vs. linear array. Virol J 14:112|
|Thomas, Stefani N; Yang, Austin J (2017) Mass Spectrometry Analysis of Lysine Posttranslational Modifications of Tau Protein from Alzheimer's Disease Brain. Methods Mol Biol 1523:161-177|
|Kaczanowska, Sabina; Joseph, Ann Mary; Guo, Jitao et al. (2017) A Synthetic CD8?:MyD88 Coreceptor Enhances CD8+ T-cell Responses to Weakly Immunogenic and Lowly Expressed Tumor Antigens. Cancer Res 77:7049-7058|
|Larrosa-Garcia, Maria; Baer, Maria R (2017) FLT3 Inhibitors in Acute Myeloid Leukemia: Current Status and Future Directions. Mol Cancer Ther 16:991-1001|
|Stick, Line B; Yu, Jen; Maraldo, Maja V et al. (2017) Joint Estimation of Cardiac Toxicity and Recurrence Risks After Comprehensive Nodal Photon Versus Proton Therapy for Breast Cancer. Int J Radiat Oncol Biol Phys 97:754-761|
|Connolly, Nina P; Stokum, Jesse A; Schneider, Craig S et al. (2017) Genetically engineered rat gliomas: PDGF-driven tumor initiation and progression in tv-a transgenic rats recreate key features of human brain cancer. PLoS One 12:e0174557|
|Carter-Cooper, Brandon A; Fletcher, Steven; Ferraris, Dana et al. (2017) Synthesis, characterization and antineoplastic activity of bis-aziridinyl dimeric naphthoquinone - A novel class of compounds with potent activity against acute myeloid leukemia cells. Bioorg Med Chem Lett 27:6-10|
|Young, Christina A; Rorke, Ellen A; Adhikary, Gautam et al. (2017) Loss of epidermal AP1 transcription factor function reduces filaggrin level, alters chemokine expression and produces an ichthyosis-related phenotype. Cell Death Dis 8:e2840|
|Nowak, Rebecca G; Bentzen, Søren M; Ravel, Jacques et al. (2017) Rectal microbiota among HIV-uninfected, untreated HIV, and treated HIV-infected in Nigeria. AIDS 31:857-862|
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