The UC Davis Cancer Center has established a Data and Safety Monitoring Plan (DSMP) that ensures patient safety, protocol adherance, and the quality of data for all cancer-related trials being carried out by UCD investigators, including those carried out in the VA Mather and Cancer Care Network. The DSMP is undertaken by the Data and Safety Monitoring Committee (DSMC) and the Quality Assurance Committee (QAC). A study-specific Data and Safety Monitoring Board (DSMB) may also be assigned to certain trials deemed by the Scientific Review Committee as being of higher risk to patients. The primary responsibility of the DSMC Is to review all serious adverse events (SAEs). It also monitors the overall progress and safety ofthe trial (e.g., QAC input and, where applicable, dose escalations). The DSMC (and DSMB) have the authority to close or suspend trials on the basis of safety concerns, the recognition of early attainment of study objectives, indication of futility, or inadequate performance. Regular quality assurance audits (QAAs) verify that enrolled patients are eligible, adequately screened, and treated according to protocol. Every month, 2 or 3 trials are selected at random to be audited by the Quality Assurance Board (QAB). The QAC discusses the QAA results, assigns an overall score, and informs the PI of any action required. The DSMP delineates the communication systems that are in place that ensure feedback of critical information, especially that related to SAEs, across all key stakeholders. This includes having a centralized system for multicenter trials for the collection and reporting of AEs to each participating PI. The DSMC notifies the IRB if a trial is terminated or suspended and DSMC minutes are circulated to the IRB.
In clinical trials, the safety of patients is paramount. The DSMP ensures patient safety by having systems in place that review all SAEs, verify that patients are being treated according to protocol, monitor the quality of the data, ensure that all key stakeholders are notified of SAEs and trial terminations/suspensions, and provide oversight to the overall progress and safety of the trial.
|Pol, Arjan; Renkema, G Herma; Tangerman, Albert et al. (2018) Mutations in SELENBP1, encoding a novel human methanethiol oxidase, cause extraoral halitosis. Nat Genet 50:120-129|
|Wang, Yuru; Park, SeHee; Beal, Peter A (2018) Selective Recognition of RNA Substrates by ADAR Deaminase Domains. Biochemistry 57:1640-1651|
|Campbell, Mel; Watanabe, Tadashi; Nakano, Kazushi et al. (2018) KSHV episomes reveal dynamic chromatin loop formation with domain-specific gene regulation. Nat Commun 9:49|
|Vogel Ciernia, Annie; Careaga, Milo; LaSalle, Janine M et al. (2018) Microglia from offspring of dams with allergic asthma exhibit epigenomic alterations in genes dysregulated in autism. Glia 66:505-521|
|Li, Peng-Cheng; Tu, Mei-Juan; Ho, Pui Yan et al. (2018) Bioengineered NRF2-siRNA Is Effective to Interfere with NRF2 Pathways and Improve Chemosensitivity of Human Cancer Cells. Drug Metab Dispos 46:2-10|
|Lucchesi, Christopher A; Zhang, Jin; Ma, Buyong et al. (2018) Disruption of the Rbm38-eIF4E complex with a synthetic peptide Pep8 increases p53 expression. Cancer Res :|
|Kiuru, Maija; Tartar, Danielle M; Qi, Lihong et al. (2018) Improving classification of melanocytic nevi: Association of BRAF V600E expression with distinct histomorphologic features. J Am Acad Dermatol 79:221-229|
|Pargett, Michael; Albeck, John G (2018) Live-Cell Imaging and Analysis with Multiple Genetically Encoded Reporters. Curr Protoc Cell Biol 78:4.36.1-4.36.19|
|Fishman, Scott M; Carr, Daniel B; Hogans, Beth et al. (2018) Scope and Nature of Pain- and Analgesia-Related Content of the United States Medical Licensing Examination (USMLE). Pain Med 19:449-459|
|Lewis, Daniel D; Chavez, Michael; Chiu, Kwan Lun et al. (2018) Reconfigurable Analog Signal Processing by Living Cells. ACS Synth Biol 7:107-120|
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