CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) - ABSTRACT The Karmanos Cancer Institute Clinical Trials Office (CTO) serves as a centralized resource providing CPDM services and support to the Cancer Center with the highest priority being the safety of participating patients. The CTO provides comprehensive regulatory support from protocol conception to activation, including liaison and communication with the all applicable Institutional Review Boards (IRBs) and sponsors to facilitate timely initiation and completion of clinical trial activities, all approval and review processes with the IRB, Investigational New Drug (IND) support, registration of new trials with NCI Clinical Trials Reporting Program (CTRP) and appropriate registration and results reporting with ClinicalTrials.gov. CPDM services facilitate and optimize accrual by providing centralized and trained data management and research nurse support to KCI physicians and clinical support staff. The CTO interfaces with several Shared Resources to facilitate and enhance collaboration, improve processes and ensure efficient and effective use of resources. The Clinical Trial Management System OnCore is utilized to administer all clinical trial requirements. The CTO supports National Clinical Trials Network, NCI-funded peer reviewed, investigator-initiated, and industry sponsored protocols. KCI/WSU is a Lead Academic Participating Site under the NCTN (UG1CA233163). Effective quality control and training is provided by the CTO to ensure compliance to the Data and Safety Monitoring Plan (DSMP). This includes coordination and administrative support to the Feasibility Review and Operations Committee (FROC), Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring Committee (DSMC) and the Quality Assurance Committee (QAC). During the current grant period the number of CTO staff increased from 108.85 to 154.45 FTE, providing CPDM services in support of over 500 active protocols at any one time. The number of Network sites offering clinical trials increased by 33% resulting in a 6.8-fold increase in accruals to interventional trials at KCI Network sites (94 in 2015 to 641 in 2019). Strong Network site accruals led to an increase in NRG Lead Academic Participating Sites (LAPS) trial accrual ranking to #3 for 2019. Efforts toward reduction of protocol activation times led to a 2.8-fold decrease in median activation time from 213 days in 2017 to 75 days in November of 2019. KCI supports multiple, proactive efforts to promote the recruitment of women and minorities. These efforts have resulted in exceptional enrollment of minorities and women to interventional trials over the current grant period with 24.2% accrual of minorities and 58.1% accrual of women in 2019. KCI partners with Children?s Hospital of Michigan (CHM) to facilitate pediatric accrual to clinical trials. Pediatric cancer specialists at CHM actively participate as a member institution of the Children?s Oncology Group (COG) (U10CA180886). The CTO supports robust accrual of participants across the lifespan from pediatric/adolescents to older adults.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA022453-39
Application #
10088984
Study Section
Special Emphasis Panel (ZCA1)
Project Start
1997-08-08
Project End
2025-11-30
Budget Start
2020-12-15
Budget End
2021-11-30
Support Year
39
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Wayne State University
Department
Type
DUNS #
001962224
City
Detroit
State
MI
Country
United States
Zip Code
48202
Campbell, Douglas H; Lund, Maria E; Nocon, Aline L et al. (2018) Detection of glypican-1 (GPC-1) expression in urine cell sediments in prostate cancer. PLoS One 13:e0196017
Sexton, Rachel E; Hachem, Ali H; Assi, Ali A et al. (2018) Metabotropic glutamate receptor-1 regulates inflammation in triple negative breast cancer. Sci Rep 8:16008
Cheriyan, Vino T; Alsaab, Hashem; Sekhar, Sreeja et al. (2018) A CARP-1 functional mimetic compound is synergistic with BRAF-targeting in non-small cell lung cancers. Oncotarget 9:29680-29697
Saadat, Nadia; Liu, Fangchao; Haynes, Brittany et al. (2018) Nano-delivery of RAD6/Translesion Synthesis Inhibitor SMI#9 for Triple-negative Breast Cancer Therapy. Mol Cancer Ther 17:2586-2597
Dedigama-Arachchige, Pavithra M; Acharige, Nuwan P N; Pflum, Mary Kay H (2018) Identification of PP1-Gadd34 substrates involved in the unfolded protein response using K-BIPS, a method for phosphatase substrate identification. Mol Omics 14:121-133
Burl, Rayanne B; Ramseyer, Vanesa D; Rondini, Elizabeth A et al. (2018) Deconstructing Adipogenesis Induced by ?3-Adrenergic Receptor Activation with Single-Cell Expression Profiling. Cell Metab 28:300-309.e4
Thakur, Manish K; Ruterbusch, Julie J; Schwartz, Ann G et al. (2018) Risk of Second Lung Cancer in Patients with Previously Treated Lung Cancer: Analysis of Surveillance, Epidemiology, and End Results (SEER) Data. J Thorac Oncol 13:46-53
Desai, Pinkal; Wallace, Robert; Anderson, Matthew L et al. (2018) An analysis of the association between statin use and risk of endometrial and ovarian cancers in the Women's Health Initiative. Gynecol Oncol 148:540-546
Mitrea, Cristina; Wijesinghe, Priyanga; Dyson, Greg et al. (2018) Integrating 5hmC and gene expression data to infer regulatory mechanisms. Bioinformatics 34:1441-1447
Ma, Huiyan; Ursin, Giske; Xu, Xinxin et al. (2018) Body mass index at age 18 years and recent body mass index in relation to risk of breast cancer overall and ER/PR/HER2-defined subtypes in white women and African-American women: a pooled analysis. Breast Cancer Res 20:5

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