The Clinical Protocol and Data Management Core (CPDMC) is a collaborative integrated unit staffed by professionals with expertise in protocol data management and clinical research informatics, to provide centralized infrastructure and support for the effective efficient conduct of clinical research. Working closely with the Biostatistics Core, this team blends technical and scientific expertise to provide City of Hope investigators with world-class research support and informatics solutions for clinical trials, observational studies, and outcomes research. The CPDMC offers comprehensive services to COH Cancer Center members including: protocol document management, electronic data capture, standardized clinical research staff training and education, honest broker process for accessing tissue samples, study recruitment tracking, patient safety decision support tools, data quality assurance and monitoring, multisite coordination, and customized and routine reports, including CCSG Summaries 3 and 4. The CPDMC provides input into developing protocols with respect to practicality and appropriateness of protocol management, study calendar, and data collection issues. Data Quality Monitors ensure that study research staff are fully trained in protocol management, data collection, and overall study conduct according to Good Clinical Practice (GCP) and COH policies. The CPDMC database monitors ensure that protocol and patient registration is carried out according to NCI guidelines. Key informatics services provided include;Clinical Trial Management Systems to manage planning, execution, and reporting of clinical research studies;Electronic Data Capture to provide electronic case report forms;and Clinical Research Decision Support to translate data into scientific decisions. Our emerging work on Translational Research Informatics includes implementation of the enterprise data warehouse, i2b2 open source system for cohort selection for tissue correlative studies, along with Electronic Lab Notebook and Laboratory Information Management Systems. For all these functions we use international architectural and vocabulary standards and project management methodologies to deliver clinical and translational informatics applications. In summary, the CPDMC delivers resources, education, and information management processes to establish best practices in accordance with FDA, GCP, regulatory requirements such as 21 CFR Part 11, and international data standards such as HL7, SNOMED, and LOINC The Core's services are available to all COH faculty, with COH Cancer Center members receiving the highest priority.
The overall goal of the Clinical Protocol and Data Management core facility is to provide centralized infrastructure and support for effective, efficient conduct of clinical research including protocol document management, electronic data capture, standardized training and education, study tracking, patient safety decision support tools, quality assurance and monitoring and reporting. This goal enhances the Cancer Center's dedication to developing innovative new disease-fighting strategies in the battle against cancer.
|Gast, Charles E; Silk, Alain D; Zarour, Luai et al. (2018) Cell fusion potentiates tumor heterogeneity and reveals circulating hybrid cells that correlate with stage and survival. Sci Adv 4:eaat7828|
|Salgia, Ravi; Kulkarni, Prakash (2018) The Genetic/Non-genetic Duality of Drug 'Resistance' in Cancer. Trends Cancer 4:110-118|
|Yoon, Sorah; Wu, Xiwei; Armstrong, Brian et al. (2018) An RNA Aptamer Targeting the Receptor Tyrosine Kinase PDGFR? Induces Anti-tumor Effects through STAT3 and p53 in Glioblastoma. Mol Ther Nucleic Acids 14:131-141|
|Yim, John H; Choi, Audrey H; Li, Arthur X et al. (2018) Identification of Tissue-Specific DNA Methylation Signatures for Thyroid Nodule Diagnostics. Clin Cancer Res :|
|Wang, Tianyi; Fahrmann, Johannes Francois; Lee, Heehyoung et al. (2018) JAK/STAT3-Regulated Fatty Acid ?-Oxidation Is Critical for Breast Cancer Stem Cell Self-Renewal and Chemoresistance. Cell Metab 27:136-150.e5|
|Magilnick, Nathaniel; Boldin, Mark P (2018) Molecular Moirai: Long Noncoding RNA Mediators of HSC Fate. Curr Stem Cell Rep 4:158-165|
|Yun, Xinwei; Zhang, Keqiang; Wang, Jinhui et al. (2018) Targeting USP22 Suppresses Tumorigenicity and Enhances Cisplatin Sensitivity Through ALDH1A3 Downregulation in Cancer-Initiating Cells from Lung Adenocarcinoma. Mol Cancer Res 16:1161-1171|
|Herrera, Alex F; Rodig, Scott J; Song, Joo Y et al. (2018) Outcomes after Allogeneic Stem Cell Transplantation in Patients with Double-Hit and Double-Expressor Lymphoma. Biol Blood Marrow Transplant 24:514-520|
|Slavin, Thomas P; Banks, Kimberly C; Chudova, Darya et al. (2018) Identification of Incidental Germline Mutations in Patients With Advanced Solid Tumors Who Underwent Cell-Free Circulating Tumor DNA Sequencing. J Clin Oncol :JCO1800328|
|Shahin, Sophia A; Wang, Ruining; Simargi, Shirleen I et al. (2018) Hyaluronic acid conjugated nanoparticle delivery of siRNA against TWIST reduces tumor burden and enhances sensitivity to cisplatin in ovarian cancer. Nanomedicine 14:1381-1394|
Showing the most recent 10 out of 1396 publications