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.
| Gonzalez-Mercado, Velda J; Fridley, Brooke L; Saligan, Leorey N (2018) Sestrin family of genes and their role in cancer-related fatigue. Support Care Cancer 26:2071-2074 |
| Rebbeck, Timothy R (see original citation for additional authors) (2018) Mutational spectrum in a worldwide study of 29,700 families with BRCA1 or BRCA2 mutations. Hum Mutat 39:593-620 |
| Roy, Anuradha (2018) Early Probe and Drug Discovery in Academia: A Minireview. High Throughput 7: |
| Lea, Wendy A; Parnell, Stephen C; Wallace, Darren P et al. (2018) Human-Specific Abnormal Alternative Splicing of Wild-Type PKD1 Induces Premature Termination of Polycystin-1. J Am Soc Nephrol 29:2482-2492 |
| Hirst, Jeff; Pathak, Harsh B; Hyter, Stephen et al. (2018) Licofelone Enhances the Efficacy of Paclitaxel in Ovarian Cancer by Reversing Drug Resistance and Tumor Stem-like Properties. Cancer Res 78:4370-4385 |
| Trinca, Gloria M; Goodman, Merit L; Papachristou, Evangelia K et al. (2018) O-GlcNAc-Dependent Regulation of Progesterone Receptor Function in Breast Cancer. Horm Cancer 9:12-21 |
| Subramaniam, Dharmalingam; Kaushik, Gaurav; Dandawate, Prasad et al. (2018) Targeting Cancer Stem Cells for Chemoprevention of Pancreatic Cancer. Curr Med Chem 25:2585-2594 |
| Beadnell, Thomas C; Scheid, Adam D; Vivian, Carolyn J et al. (2018) Roles of the mitochondrial genetics in cancer metastasis: not to be ignored any longer. Cancer Metastasis Rev : |
| Li, Linda Xiaoyan; Zhou, Julie Xia; Calvet, James P et al. (2018) Lysine methyltransferase SMYD2 promotes triple negative breast cancer progression. Cell Death Dis 9:326 |
| Peng, Weidan; Furuuchi, Narumi; Aslanukova, Ludmila et al. (2018) Elevated HuR in Pancreas Promotes a Pancreatitis-Like Inflammatory Microenvironment That Facilitates Tumor Development. Mol Cell Biol 38: |
Showing the most recent 10 out of 177 publications
