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 #
5P30CA138292-06
Application #
8634051
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
6
Fiscal Year
2014
Total Cost
$48,346
Indirect Cost
$17,355
Name
Emory University
Department
Type
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
Patel, Kirtesh R; Chowdhary, Mudit; Switchenko, Jeffrey M et al. (2016) BRAF inhibitor and stereotactic radiosurgery is associated with an increased risk of radiation necrosis. Melanoma Res 26:387-94
Berg, Carla J; Stratton, Erin; Esiashvili, Natia et al. (2016) Young Adult Cancer Survivors' Experience with Cancer Treatment and Follow-Up Care and Perceptions of Barriers to Engaging in Recommended Care. J Cancer Educ 31:430-42
Yoshida, Michihiro; He, Peijian; Yun, C Chris (2016) Transgenic Expression of Human Lysophosphatidic Acid Receptor LPA2 in Mouse Intestinal Epithelial Cells Induces Intestinal Dysplasia. PLoS One 11:e0154527
Horton, John R; Liu, Xu; Gale, Molly et al. (2016) Structural Basis for KDM5A Histone Lysine Demethylase Inhibition by Diverse Compounds. Cell Chem Biol 23:769-81
Bonner, Michael Y; Karlsson, Isabella; Rodolfo, Monica et al. (2016) Honokiol bis-dichloroacetate (Honokiol DCA) demonstrates activity in vemurafenib-resistant melanoma in vivo. Oncotarget 7:12857-68
Bajpai, R; Matulis, S M; Wei, C et al. (2016) Targeting glutamine metabolism in multiple myeloma enhances BIM binding to BCL-2 eliciting synthetic lethality to venetoclax. Oncogene 35:3955-64
Xiao, Canhua; Miller, Andrew H; Felger, Jennifer et al. (2016) A prospective study of quality of life in breast cancer patients undergoing radiation therapy. Adv Radiat Oncol 1:10-16
Owonikoko, Taofeek K; Zhang, Guojing; Kim, Hyun S et al. (2016) Patient-derived xenografts faithfully replicated clinical outcome in a phase II co-clinical trial of arsenic trioxide in relapsed small cell lung cancer. J Transl Med 14:111
Oliver, Daniel E; Patel, Kirtesh R; Switchenko, Jeffrey et al. (2016) Roles of adjuvant and salvage radiotherapy for desmoplastic melanoma. Melanoma Res 26:35-41
Liu, Min; Wang, Hongyan; Lee, Solah et al. (2016) DNA repair pathway choice at various conditions immediately post irradiation. Int J Radiat Biol 92:819-822

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