The Winship Cancer Institute (Winship) is committed to maintaining high standards for data and safety monitoring of all clinical studies. To achieve this goal, Winship has developed a Data and Safety Monitoring Plan (DSMP) to ensure the following: the safety of all research participants;the ethical conduct of studies;and the achievement of scientific goals through high-quality data collection. An independent data and safety monitoring committee (DSMC) is charged with oversight of all investigator-Initiated and cooperative group trials. The DSMC includes physicians, research nurses, monitors, a statistician and a patient representative. This committee meets on a monthly basis to review ongoing studies, identify potential problems and assists investigators with developing appropriate corrective action plans. The DSMC is distinct and separate from the activities and management of the Clinical Trials Office and from the Clinical and Translational Review Committee which is an integral part of the Protocol Review and Monitoring System. The DSMC is led by one of Winship's outstanding clinical investigators, Suresh Ramalingam, M.D., associate professor of Hematology and Medical Oncology.

Public Health Relevance

The DSMC coordinates, conducts and/or oversees all routine internal monitoring of investigator-initiated trials and cooperative group trials and audits conducted for cause. The relevance of this committee is to ensure that research conducted at Winship produces high-quality scientific data in a manner consistent with good clinical pracfice and appropriate regulations that govern clinical research.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA138292-05
Application #
8520243
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
5
Fiscal Year
2013
Total Cost
$50,225
Indirect Cost
$18,030
Name
Emory University
Department
Type
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
Havel, L S; Kline, E R; Salgueiro, A M et al. (2015) Vimentin regulates lung cancer cell adhesion through a VAV2-Rac1 pathway to control focal adhesion kinase activity. Oncogene 34:1979-90
Forghani, Parvin; Khorramizadeh, Mohammad R; Waller, Edmund K (2014) Silibinin inhibits accumulation of myeloid-derived suppressor cells and tumor growth of murine breast cancer. Cancer Med 3:215-24
Smith, Alicia K; Conneely, Karen N; Pace, Thaddeus W W et al. (2014) Epigenetic changes associated with inflammation in breast cancer patients treated with chemotherapy. Brain Behav Immun 38:227-36
Ha, Shin-Woo; Weitzmann, M Neale; Beck Jr, George R (2014) Bioactive silica nanoparticles promote osteoblast differentiation through stimulation of autophagy and direct association with LC3 and p62. ACS Nano 8:5898-910
Nooka, Ajay K; Johnson, Heather R; Kaufman, Jonathan L et al. (2014) Pharmacoeconomic analysis of palifermin to prevent mucositis among patients undergoing autologous hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 20:852-7
Capaldo, Christopher T; Farkas, Attila E; Hilgarth, Roland S et al. (2014) Proinflammatory cytokine-induced tight junction remodeling through dynamic self-assembly of claudins. Mol Biol Cell 25:2710-9
Sullivan, Harold C; Oprea-Ilies, Gabriela; Adams, Amy L et al. (2014) Triple-negative breast carcinoma in African American and Caucasian women: clinicopathology, immunomarkers, and outcome. Appl Immunohistochem Mol Morphol 22:17-23
Brodie, Seth A; Li, Ge; El-Kommos, Adam et al. (2014) Class I HDACs are mediators of smoke carcinogen-induced stabilization of DNMT1 and serve as promising targets for chemoprevention of lung cancer. Cancer Prev Res (Phila) 7:351-61
Wang, Hongyan; Wang, Ya (2014) Heavier ions with a different linear energy transfer spectrum kill more cells due to similar interference with the Ku-dependent DNA repair pathway. Radiat Res 182:458-61
Jurchenko, Carol; Chang, Yuan; Narui, Yoshie et al. (2014) Integrin-generated forces lead to streptavidin-biotin unbinding in cellular adhesions. Biophys J 106:1436-46

Showing the most recent 10 out of 49 publications