Browsing by Subject "clinical research management"
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Item A Comparative Review of Screening, Consent, and Trial Visits and Follow-up Practices in Cardiovascular Dual Antiplatelet Therapy Drug, Device, and Registry Studies at Legacy Heart Center and The Heart Hospital Baylor Plano(2014-12-01) Mohiuddin, Ismail S.; Patricia A. Gwirtz; Rustin E. ReevesCoronary artery disease (CAD) is the number one cause of death in the United States and a large amount of research has been conducted to find the best treatment strategy to treat and prevent it. The PEGASUS-TIMI 54 study, a drug trial, the PzF SHIELD study, a device trial, and the TIGRIS study, a registry trial, build off of that research and are seeking novel strategies to improve patient outcomes There are significant differences between drug, device, and registry clinical research trials. Comparing these three dual antiplatelet research studies on the basis of screening, consent, and trial visits and follow-up practices gives insight into the distinct features of each kind of clinical research trial.Item A Quality Improvement Initiative: Evaluating the Impact of Standardized Data Tracking Tools in the Radiation Oncology Clinical Research Office at the University of Texas Southwestern Medical Center(2022-05) Acevedo, Katalina V.; Mathew, Stephen O.; Ranjan, Amalendu P.Developing preventative measures through intentional planning and oversight of clinical trials has the potential to increase efficiency and quality of trial processes and data. This practicum report details a Quality Improvement (QI) initiative evaluating implementation and impact of a standardized data-tracking software on clinical research data compliance in the Radiation Oncology Clinical Research Office at UT Southwestern Medical Center (UTSW). The standardized data tracker evaluated in this study was built through Quickbase, a cloud-based, low-code application development platform specializing in project management and operations optimization. This project evaluated data sets from two active radiation oncology clinical trials using repeated cross-sectional methods to compare rates of data non-compliance and trends in the types of non-compliance exhibited at baseline, one-month, and three-month post data-tracker implementation. Trends in non-compliance were reviewed and preventative measures backed by recommendations from the literature were proposed to facilitate future QI initiatives within the department. The Chi-Squared (X2) Test for Independence was used to determine whether there was a statistical difference in rates of data non-compliance across the three timepoints within studies and overall followed by post-hoc tests consisting of pairwise comparisons with Bonferroni corrections. Overall, statistical analysis revealed a significant difference in rates on non- compliance across timepoints, suggesting that implementation of the standardized Quickbase data-tracking management tool does significantly decrease rates of non-compliance. Descriptive statistics were performed to characterize the trends in non-compliance within each study across timepoints. This quality improvement project was the first of its kind to formally examine data management trends and practices within the Radiation Oncology Clinical Research Office at UT Southwestern Medical Center. The results provide positive feedback regarding the implementation of a standardized Quickbase data-tracking management tool and characterization of non-compliant data illuminated pressure points in data management workflow that can inform future QI initiatives in shifting data management from its current reactive state to a more proactive data-driven approach. Future work should evaluate the proposed preventative measurements to provide further insight into best practices that can support continuous improvement initiatives within the department.Item Analysis of Efficiency and User Satisfaction Following the Introduction of Digital Source Documents and Resources in a Clinical Research Setting(2015-12-01) Alosi, Marlena C.; Ladislav Dory; Patricia A. Gwirtz; Ray PageEfficient and accurate data management processes are essential for the successful conduction of clinical trials. The clinical research industry is unique among biomedical fields in that much of the reporting is still conducted using paper-based systems. Recent trends towards exchanging paper-based documentation methods for electronic documentation methods have shown that implementation of digital resources have the potential to expedite clinical development. This practicum sought to evaluate paper-based and electronic documentation processes in a cancer clinic in regards to efficiency and user satisfaction, and determine which documentation form was superior in these areas. Retrospective analyses and a survey were used as the sources of data to assess for these differences. It was determined that the replacement of paper-based methods with electronic methods of documentation at this particular clinic resulted in both greater timeliness and higher user satisfaction.Item Compare and Contrast Traditional (Paper) and New (Electronic) Clinical Data Collection Systems Perspective of the Investigative Site(2005-05-01) Tsai, David C.; Harold Sheedio; Don Peska; Myoung KimTsai, David C. Compare and Contrast Traditional (Paper) and New (Electronic) Clinical Data Collection Systems-Perspective of the Investigative Site. Masters of Science (Clinical Research Management), April 2006, 83pp., 1 table, 4 figures, bibliography, 12 titles. The emergence of new technology in the form of Electronic Data Capture (EDC) for clinical trials has the potential to overcome the inefficiencies of Traditional Paper Data Capture. However, due to the novelty of Electronic Data Capture Systems in the marketplace, several issues have to be worked out to insure that these systems will be successfully adapted. Among these issues are those concerning personnel training, infrastructure reliability, FDA involvement, and pharmaceutical company acceptance of EDC systems. The emphasis of my clinical research management internship focused on gathering survey responses comparing the two systems in order to determine if the advertise efficiencies of EDC systems were valid.Item Using a Database to Facilitate the Accrual of Geriatric Subjects with Dementia for Clinical Research Studies(2007-04-23) Alexander, Jessica; Patricia Gwirtz; Janice Knebl; Barbara HartyThe internship and practicum project activities took place in an established geriatric practice that provides care to more than 2,000 patients over the age of 65. Research studies and clinical trials conducted at this site are specifically aimed at either testing the efficacy of medications and treatments in the elderly or researching disease processes predominantly found within the older population. This geriatric practice is led by Dr. Janice Knebl with the assistance of Barbara Harty, who is a seasoned geriatric nurse practitioner, IRB board member, clinical coordinator, and my mentor during the internship. The overall objective of the internship was to build a functional knowledge of how to manage research with human subjects. The internship experience spanned several domains within the field of clinical research management: clinical coordination, contract management, institutional research management, and data/records management. Within the course of the internship and implementation of the practicum project there were more than 1040 hours logged working within these areas of concentration in order to achieve that goal. The following is a narrative account of those experiences that details the Internship/Activity Log submitted as Appendix A of this report.