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.
|NygÃ¥rd, Lotte; Vogelius, Ivan R; Fischer, Barbara M et al. (2016) Early lesion-specific (18)F-FDG PET response to chemotherapy predicts time to lesion progression in locally advanced non-small cell lung cancer. Radiother Oncol 118:460-4|
|Fox, Jennifer M; Moynihan, James R; Mott, Bryan T et al. (2016) Artemisinin-derived dimer ART-838 potently inhibited human acute leukemias, persisted in vivo, and synergized with antileukemic drugs. Oncotarget 7:7268-79|
|Joseph, Ann Mary; Srivastava, Ratika; Zabaleta, Jovanny et al. (2016) Cross-talk between 4-1BB and TLR1-TLR2 Signaling in CD8+ T Cells Regulates TLR2's Costimulatory Effects. Cancer Immunol Res 4:708-16|
|Zandberg, Dan P; Liu, Sandy; Goloubeva, Olga et al. (2016) Oropharyngeal cancer as a driver of racial outcome disparities in squamous cell carcinoma of the head and neck: 10-year experience at the University of Maryland Greenebaum Cancer Center. Head Neck 38:564-72|
|Doshi, Kshama A; Trotta, Rossana; Natarajan, Karthika et al. (2016) Pim kinase inhibition sensitizes FLT3-ITD acute myeloid leukemia cells to topoisomerase 2 inhibitors through increased DNA damage and oxidative stress. Oncotarget 7:48280-48295|
|Ambulos Jr, Nicholas P; Schumaker, Lisa M; Mathias, Trevor J et al. (2016) Next-Generation Sequencing-Based HPV Genotyping Assay Validated in Formalin-Fixed, Paraffin-Embedded Oropharyngeal and Cervical Cancer Specimens. J Biomol Tech 27:46-52|
|Temburnikar, Kartik W; Ross, Christina R; Wilson, Gerald M et al. (2015) Antiproliferative activities of halogenated pyrrolo[3,2-d]pyrimidines. Bioorg Med Chem 23:4354-63|
|Kochel, Tyler J; Fulton, Amy M (2015) Multiple drug resistance-associated protein 4 (MRP4), prostaglandin transporter (PGT), and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) as determinants of PGE2 levels in cancer. Prostaglandins Other Lipid Mediat 116-117:99-103|
|Rasmussen, Jacob H; Vogelius, Ivan R; Aznar, Marianne C et al. (2015) Spatio-temporal stability of pre-treatment 18F-Fludeoxyglucose uptake in head and neck squamous cell carcinomas sufficient for dose painting. Acta Oncol 54:1416-22|
|Shih, Yu-Huan; Zhang, Yuji; Ding, Yonghe et al. (2015) Cardiac transcriptome and dilated cardiomyopathy genes in zebrafish. Circ Cardiovasc Genet 8:261-9|
Showing the most recent 10 out of 207 publications