The Mayo Clinic Cancer Center (MCCC) Clinical Protocol and Data Management (CPDM) functions are administratively overseen by the MCCC Clinical Research Committee (Chaired by the MCCC Deputy Director for Clinical Research) and functionally coordinated by the MCCC Clinical Research Office (CRO), the Data and Safety Monitoring Committee (DSMC), and the Data and Safety Monitoring Board (DSMB). The CPDM functions include clinical research operations and data quality monitoring, facilitated by the Medical Director and Administrative Director and supported by the CRO staff. The CRO carries out development, activation, study maintenance, study coordination, administration, and reporting for all cancer clinical trials conducted at the MCCC. In addition, the CRO provides operational support for the Protocol Review and Monitoring System (PRMS) and the Data and Safety Monitoring (DSM) System. The CPDM and DSM functions at MCCC are distinct from PRMS functions, with minor overlap of membership. Staff in the CRO work collaboratively with the MCCC clinical investigators to provide expert, efficient support in the conduct of clinical research across the enterprise and with individual Disease Groups to ensure efficient development and activation of clinical trials consistent with the priorities of the MCCC Programs. Over the past grant period, the CRO has overseen the development and activation of 617 studies, including an increasingly complex portfolio of studies (e.g., checkpoint inhibitors, CAR T-cells, basket and umbrella trials with targeted therapies). It has provided staffing support in alignment with the growth of the Disease Groups, facilitated the opening of a wide variety of trials in line with Disease Group growth strategies, and maintained stable clinical trial accrual volumes over the last 3 years. With the creation of the integrated Early Cancer Therapeutics (ECTx) unit and the growth of the Cellular Therapy Disease Group, the CRO continues to evolve to efficiently support novel, complex, and innovative trials. Significant progress has been made to improve the clinical trial activation process to address efficiency, time to activation, and quality. Ongoing developments will include the implementation of a new clinical research management system. MCCC provides oversight for participant safety through the Center's DSM system, with functions carried out by the DSMC and the DSMB. The DSMC focuses broadly on safety rather than on individual studies. It evaluates trends in protocol deviations and toxicities and recommends MCCC-wide procedural changes aimed at ensuring that studies are conducted in accordance with MCCC's Data Safety and Monitoring Plan and with federal, local, and institutional policies. The DSMC also reviews the DSM Plan annually and oversees the DSMB functions. The DSMB focuses their review on individual studies, ensuring patient safety by regularly reviewing adverse events on study and responses to the study intervention for individual trials.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA015083-46
Application #
9938484
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2020-03-01
Budget End
2021-02-28
Support Year
46
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
Jahanseir, Khadijeh; Xing, Deyin; Greipp, Patricia T et al. (2018) PDGFB Rearrangements in Dermatofibrosarcoma Protuberans of the Vulva: A Study of 11 Cases Including Myxoid and Fibrosarcomatous Variants. Int J Gynecol Pathol 37:537-546
Painter, Jodie N; O'Mara, Tracy A; Morris, Andrew P et al. (2018) Genetic overlap between endometriosis and endometrial cancer: evidence from cross-disease genetic correlation and GWAS meta-analyses. Cancer Med 7:1978-1987
Yu, Jia; Qin, Bo; Moyer, Ann M et al. (2018) DNA methyltransferase expression in triple-negative breast cancer predicts sensitivity to decitabine. J Clin Invest 128:2376-2388
Sugihara, Takaaki; Werneburg, Nathan W; Hernandez, Matthew C et al. (2018) YAP Tyrosine Phosphorylation and Nuclear Localization in Cholangiocarcinoma Cells Are Regulated by LCK and Independent of LATS Activity. Mol Cancer Res 16:1556-1567
Natanzon, Yanina; Goode, Ellen L; Cunningham, Julie M (2018) Epigenetics in ovarian cancer. Semin Cancer Biol 51:160-169
Kleinstern, Geffen; Camp, Nicola J; Goldin, Lynn R et al. (2018) Association of polygenic risk score with the risk of chronic lymphocytic leukemia and monoclonal B-cell lymphocytosis. Blood 131:2541-2551
Liu, Gang; Mukherjee, Bhramar; Lee, Seunggeun et al. (2018) Robust Tests for Additive Gene-Environment Interaction in Case-Control Studies Using Gene-Environment Independence. Am J Epidemiol 187:366-377
Ong, Jue-Sheng; Hwang, Liang-Dar; Cuellar-Partida, Gabriel et al. (2018) Assessment of moderate coffee consumption and risk of epithelial ovarian cancer: a Mendelian randomization study. Int J Epidemiol 47:450-459
Kumar, Shaji K; Buadi, Francis K; LaPlant, Betsy et al. (2018) Phase 1/2 trial of ixazomib, cyclophosphamide and dexamethasone in patients with previously untreated symptomatic multiple myeloma. Blood Cancer J 8:70
Schafer, Eric S; Rau, Rachel E; Berg, Stacey et al. (2018) A phase 1 study of eribulin mesylate (E7389), a novel microtubule-targeting chemotherapeutic agent, in children with refractory or recurrent solid tumors: A Children's Oncology Group Phase 1 Consortium study (ADVL1314). Pediatr Blood Cancer 65:e27066

Showing the most recent 10 out of 1129 publications