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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA093373-12
Application #
8743656
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
12
Fiscal Year
2014
Total Cost
$78,185
Indirect Cost
$27,246
Name
University of California Davis
Department
Type
DUNS #
047120084
City
Davis
State
CA
Country
United States
Zip Code
95618
Dou, John; Schmidt, Rebecca J; Benke, Kelly S et al. (2018) Cord blood buffy coat DNA methylation is comparable to whole cord blood methylation. Epigenetics 13:108-116
Couto, K M; Moore, P F; Zwingenberger, A L et al. (2018) Clinical characteristics and outcome in dogs with small cell T-cell intestinal lymphoma. Vet Comp Oncol 16:337-343
Xue, Xiangdong; Huang, Yee; Wang, Xinshuai et al. (2018) Self-indicating, fully active pharmaceutical ingredients nanoparticles (FAPIN) for multimodal imaging guided trimodality cancer therapy. Biomaterials 161:203-215
Ho, Pui Yan; Duan, Zhijian; Batra, Neelu et al. (2018) Bioengineered Noncoding RNAs Selectively Change Cellular miRNome Profiles for Cancer Therapy. J Pharmacol Exp Ther 365:494-506
Zuo, Yang; Qi, Jinyi; Wang, Guobao (2018) Relative Patlak plot for dynamic PET parametric imaging without the need for early-time input function. Phys Med Biol 63:165004
McGee, Heather M; Daly, Megan E; Azghadi, Sohelia et al. (2018) Stereotactic Ablative Radiation Therapy Induces Systemic Differences in Peripheral Blood Immunophenotype Dependent on Irradiated Site. Int J Radiat Oncol Biol Phys 101:1259-1270
Klapheke, Amy; Yap, Stanley A; Pan, Kevin et al. (2018) Sociodemographic disparities in chemotherapy treatment and impact on survival among patients with metastatic bladder cancer. Urol Oncol 36:308.e19-308.e25
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

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