Browsing by Subject "GI"

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Identifying and Overcoming Barriers in Clinical Research Management: A Review of Clinical Trials within an Academic Medical Center
(2008-12-01) Hatfield, Elisha
Over the decades, clinical research has grown and evolved into what one would consider now as the cornerstone of medical advancement. Through the use of clinical trials, new and improved prevention and treatments continue to be discovered. These trials are not only an essential part of the process of drug discovery and development, but are required for drug approval. Conducting these clinical trials takes diligent cooperation between the pharmaceutical industry, government agencies, investigators, and academic medical centers (AMC’s). With the implementation of new regulations as well as continual changes to policies and procedures overseeing clinical research, management of such trials has become a very meticulous and a lengthy process. Additionally, escalating costs of drug development and an increased need for new treatments in the market at faster rates have made the need for more effective and productive means of conducting clinical trials a priority for competitive research sites. With the landscape of clinical research constantly evolving, adaptation of study management and procedures is a continuous hurdle that clinical research sites must overcome. Changes in regulations, limitations of funds and the need for more effective subject recruitment methods are all barriers that most AMC’s are facing today. Finding ways to overcome these obstacles is an essential part of conducting effective and productive clinical trials. In order to keep up with this change and maintain a high quality of research, continual review and audit of current research standards and procedures has become a necessity. Review of standard operating procedures and study documentation can help identify barriers which inhibit the process and initiate appropriate modifications in order to maintain efficient and effective study trials. As such, for this Internship Practicum Project, the intern reviewed the standard procedures and monitored clinical studies with the Gastrointestinal Disease Oriented Team (GI DOT) in an attempt to identify barriers affecting the overall productivity and efficiency of the team. Once these barriers had been outlined, recommendations for changes in standard procedures were made in order to help improve the functionality of the GI DOT and, subsequently, enhance the success of GI protocols within the Simmons Cancer Center Clinical Research Office.
Impact of Endoscopic Vacuum-Assisted Closure on Quality of Life in Patients After Treatment of Gastrointestinal Leaks
(2023-05) Rana, Rashmeen K.; Malaer, Joseph D.; Preskitt, John T.; Farmer, George
Endoscopic Vacuum Assisted Wound Closure (EVAC) is an effective therapeutic option to treat Gastrointestinal (GI) leaks after the surgery. Prior to EVAC, conventional approaches to treat leaks included surgical intervention or endoscopic stents. Even though EVAC has been in use for more than a decade and has proven to be successful in treating GI leaks, the long-term quality of life impact of this treatment is uncertain. With the use of a short form (SF-36) survey, a validated questionnaire to assess both physical and mental health, the long-term impact of EVAC on the quality of life was evaluated. When assessing the long-term quality of life for patients who are at least 2 years out from their sentinel surgery, the EVAC group scored higher in all 8 quality of life domains with 4 domains reaching statistical significance as compared with conventional therapy group which received other treatments for leak management.