Browsing by Subject "Clinical research"
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Item A Phase II Clinical Study to Evaluate the Efficacy and Safety of rhThrombin in Subjects Undergoing Arterial Bypass Surgery and AV Graft Formation for Hemodialysis(2004-12-01) Plascencia, Xochitl; Rustin E. Reeves; Della Weis; Don PeskaThe Association of American Medical Colleges Task Force on Clinical Research defines clinical research as a component of medical and health research intended to produce knowledge essential for understanding human disease, preventing and treating illness, and promoting health (Friedman, 1998). A clinical trial is defined as a research study conducted in humans which is designed to answer specific questions using scientifically controlled conditions with specified methodologies and endpoints (Gallin, 2002). Clinical research trials are essential in determining whether or not a drug is safe and effective. There are four phases that investigational drugs go through before they are allowed to be out in the market. Before beginning phase I of a study, there is usually a pre-clinical research and development phase. During this time the initial synthesis of study drug is accomplished and animal testing takes place. Phase I is the initial introduction of an investigational new study drug into humans. Phase I is usually conducted in healthy individuals and the primary goal is to determine the safety profile of the drug. Phase II trials tend to evaluate safety and initial efficacy. Subjects enrolled in this phase tend to have the disease necessary for use of study drug. Phase III studies are conducted to gather additional information about the effectiveness and safety of the drug and to determine the overall benefit-risk relationship of the drug. Finally, phase IV studies are usually referred to as post-marketing studies. During this phase, additional safety information is identified and the drug’s safety during routine use is evaluated. Each phase can range from two to ten years depending on the complexity of the clinical trial (Gallin, 2002). A phase II, randomized, double blind study of the safety and efficacy of topical recombinant human thrombin in patients undergoing peripheral arterial bypass surgery and arterio-venous graft formation for hemodialysis is the focus of the prospective drug study to be carried out in the surgery department at The University of North Texas Health Science Center. The primary objective of this study is to evaluate the safety and efficacy of recombinant human thrombin when used in different types of surgeries. Prior to signing an informed consent, subjects will have to meet inclusion and exclusion criteria set by study protocol. Study specific assessments and procedures will be performed after the informed consent is signed and dated. If bleeding at the anastomosis is found to necessitate intervention, a single application of either rhThrombin or placebo in combination with an absorbable hemostatic sponge to each anastomosis requiring hemostasis will be applied by the surgeon. The safety and efficacy of rhThrombin will be determined by measuring the incidence and severity of adverse events and of laboratory abnormalities. Occurrence of hemostasis within 600 seconds of application of the study drug at the anastomotic surgical site, incidence of anti-rhThrombin product antibodies, and time to hemostasis will also be measured.Item Identifying and Overcoming Barriers in Clinical Research Management: A Review of Clinical Trials within an Academic Medical Center(2008-12-01) Hatfield, ElishaOver 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.