The Clinical Trials Management Shared Resource (CTMSR) is led by Raymond P. Perez, MD and provides comprehensive, centralized support services that span the life cycle of cancer clinical trials from concept through manuscript, and assures that the patient population and resources needed to successfully conduct these trials in compliance with all federal, state and local regulations are in place. A resource staff of 35.6 FTE manage a portfolio of 116 clinical protocols (19 institutional investigator-initiated, 31 industrial, and 65 from cooperative groups). The CTMSR is functionally organized into four distinct groups: (1) Study Implementation and Regulatory Compliance (11 FTE) provides project development/management and regulatory affairs functions, and administrative support for the KUCC Protocol Review and Monitoring System;(2) Research Finance (2 FTE) provides comprehensive budget development, financial management for active protocols, and research billing compliance;(3) Clinical Trials (17.6 FTE) provides research nursing, study coordination, and data management coordination;and, (4) Research Assurance (1 FTE) provides monitoring, auditing, and quality assurance/control (QA/QC) oversight of clinical research and administratively supports the KUCC Data and Safety Monitoring Committee. The CTMSR has enabled a nearly 5-fold increase in clinical trials accrual at KUCC since 2006, particularly to institutional investigator-initiated trials (IIT) that now account for almost 63% of all therapeutic enrollments. Additional operational highlights include development and improvement of standard operating procedures across the resource, particularly for financial management, where process improvements yielded a sustainable business model, and support for local and regional collaborations at multiple affiliated sites. In summary, the CTMSR has facilitated significant growth of investigator-driven clinical research at KUCC, while implementing and administering cost-effective processes to ensure that the research activities have scientific merit, protect safety, maintain scientific integrity, and are fiscally sound.
Advancing cancer care, today and tomorrow will require new and better therapies based on our ever increasing understanding of cancer and anficancer drugs. These improvements will depend on careful, properiy-conducted clinical research. The Clinical Trials Management shared resource provides KUCC cancer researchers with the support and services to conduct clinical research of the highest possible quality.
|Jiang, Yu; Simon, Steve; Mayo, Matthew S et al. (2015) Modeling and validating Bayesian accrual models on clinical data and simulations using adaptive priors. Stat Med 34:613-29|
|Zeineldin, Maged; Jensen, Derek; Paranjape, Smita R et al. (2014) Human cancer xenografts in outbred nude mice can be confounded by polymorphisms in a modifier of tumorigenesis. Genetics 197:1365-76|
|Winham, Stacey J; Armasu, Sebastian M; Cicek, Mine S et al. (2014) Genome-wide investigation of regional blood-based DNA methylation adjusted for complete blood counts implicates BNC2 in ovarian cancer. Genet Epidemiol 38:457-66|
|Block, Matthew S; Charbonneau, Bridget; Vierkant, Robert A et al. (2014) Variation in NF-?B signaling pathways and survival in invasive epithelial ovarian cancer. Cancer Epidemiol Biomarkers Prev 23:1421-7|
|Pessetto, Ziyan Y; Ma, Yan; Hirst, Jeff J et al. (2014) Drug repurposing identifies a synergistic combination therapy with imatinib mesylate for gastrointestinal stromal tumor. Mol Cancer Ther 13:2276-87|
|Purrington, Kristen S; Slager, Susan; Eccles, Diana et al. (2014) Genome-wide association study identifies 25 known breast cancer susceptibility loci as risk factors for triple-negative breast cancer. Carcinogenesis 35:1012-9|
|Bohl, Christopher R; Harihar, Sitaram; Denning, Warren L et al. (2014) Metastasis suppressors in breast cancers: mechanistic insights and clinical potential. J Mol Med (Berl) 92:13-30|
|Peterson, Kenneth R; Costa, Flávia C; Fedosyuk, Halyna et al. (2014) A cell-based high-throughput screen for novel chemical inducers of fetal hemoglobin for treatment of hemoglobinopathies. PLoS One 9:e107006|
|Meneely, Kathleen M; Luo, Qianyi; Riley, Andrew P et al. (2014) Expanding the results of a high throughput screen against an isochorismate-pyruvate lyase to enzymes of a similar scaffold or mechanism. Bioorg Med Chem 22:5961-9|
|Osorio, Ana; Milne, Roger L; Kuchenbaecker, Karoline et al. (2014) DNA glycosylases involved in base excision repair may be associated with cancer risk in BRCA1 and BRCA2 mutation carriers. PLoS Genet 10:e1004256|
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