Data and Safety Monitoring Committee (DSMC) The DSMC is the Data and Safety Monitoring Board (DSMB) for the SCC. The DSMC is a multidisciplinary committee charged with overseeing the monitoring of safety of participants in clinical trials, and the conduct, progress, validity, and integrity of the data for all clinical trials at the SCC. The committee meets monthly (see Meeting Section below for details). If a study is already being monitored by a data and safety monitoring committee formed by a national cooperative group, a pharmaceutical sponsor or a study-specific committee for a Phase III trial, the DSMC does not actively monitor the study. In this case, the DSMC reviews adverse event reports to ensure patient safety and that reporting requirements are met. The DSMC is chaired by Susan Knox, PhD, MD, Faculty Director of the CROG. Sandhya Srinivas, MD serves as the Vice Chair. The 22-member committee is multidisciplinary with a constituency that is representative of the different disease areas, departments, and roles encompassing cancer clinical trials. The DSMC committee meets monthly to review recently audited studies, adverse event reports, and protocol deviations. All clinical trials require monitoring, at a minimum once per year, commensurate with the degree of risk involved in study subject participation, the size and complexity of the study, and relevant findings from previous study audits. The DSMC focuses its internal auditing efforts on investigator-initiated (institutional) clinical trials, especially those for which there is no independent outside monitoring program. The DSMC Chair assigns a category of risk to every investigator-initiated study approved by the Scientific Review Committee (SRC);this category of risk determines the level of internal auditing required. Internal auditing is focused on protocol and regulatory compliance. Auditing includes a comprehensive review of all regulatory documentation, confirming eligibility of participants, verifying data validity and integrity, and assuring protocol compliance. The DSMC has the authority to require protocol amendments and to recommend suspension or termination of any research activities that fall within its jurisdiction. The DSMC can institute any other appropriate conditions needed for subject safety and protocol compliance. When the DSMC recommends suspension, or study closure, the Chair or Vice Chair notifies the PI and the IRB by letter at the same time. The Director of the CROG, the Associate Director of Clinical Research, and the Chair of the SRC are also informed.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Stanford University
United States
Zip Code
Ganjoo, Kristen; Hong, Fangxin; Horning, Sandra J et al. (2014) Bevacizumab and cyclosphosphamide, doxorubicin, vincristine and prednisone in combination for patients with peripheral T-cell or natural killer cell neoplasms: an Eastern Cooperative Oncology Group study (E2404). Leuk Lymphoma 55:768-72
Chiou, Shin-Heng; Kim-Kiselak, Caroline; Risca, Viviana I et al. (2014) A conditional system to specifically link disruption of protein-coding function with reporter expression in mice. Cell Rep 7:2078-86
Zhu, Gefei Alex; Danial, Christina; Liu, Andy et al. (2014) Overall and progression-free survival in metastatic basosquamous cancer: a case series. J Am Acad Dermatol 70:1145-6
Caswell, Deborah R; Chuang, Chen-Hua; Yang, Dian et al. (2014) Obligate progression precedes lung adenocarcinoma dissemination. Cancer Discov 4:781-9
Bartroff, Jay; Lai, Tze Leung; Narasimhan, Balasubramanian (2014) A new approach to designing phase I-II cancer trials for cytotoxic chemotherapies. Stat Med 33:2718-35
Kohrt, Holbrook E; Thielens, Ariane; Marabelle, Aurelien et al. (2014) Anti-KIR antibody enhancement of anti-lymphoma activity of natural killer cells as monotherapy and in combination with anti-CD20 antibodies. Blood 123:678-86
DiCarlo, Joseph; Agarwal-Hashmi, Rajni; Shah, Ami et al. (2014) Cytokine and chemokine patterns across 100 days after hematopoietic stem cell transplantation in children. Biol Blood Marrow Transplant 20:361-9
Chang, Serena; Kohrt, Holbrook; Maecker, Holden T (2014) Monitoring the immune competence of cancer patients to predict outcome. Cancer Immunol Immunother 63:713-9
Ansari, Celina; Tikhomirov, Grigory A; Hong, Su Hyun et al. (2014) Development of novel tumor-targeted theranostic nanoparticles activated by membrane-type matrix metalloproteinases for combined cancer magnetic resonance imaging and therapy. Small 10:566-75, 417
Lavori, Philip W; Dawson, Ree (2014) Introduction to dynamic treatment strategies and sequential multiple assignment randomization. Clin Trials 11:393-399

Showing the most recent 10 out of 24 publications