Browsing by Subject "clinical trial"
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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 A Precision Medicine Approach to Treating Alzheimer's Disease Using Rosiglitazone Therapy: A Biomarker Analysis of the REFLECT Trials(IOS Press, 2021-05-18) O'Bryant, Sid E.; Zhang, Fan; Petersen, Melissa E.; Johnson, Leigh A.; Hall, James R.; Rissman, Robert A.Background: The REFLECT trials were conducted to examine the treatment of mild-to-moderate Alzheimer's disease utilizing a peroxisome proliferator-activated receptor gamma agonist. Objective: To generate a predictive biomarker indicative of positive treatment response using samples from the previously conducted REFLECT trials. Methods: Data were analyzed on 360 participants spanning multiple negative REFLECT trials, which included treatment with rosiglitazone and rosiglitazone XR. Support vector machine analyses were conducted to generate a predictive biomarker profile. Results: A pre-defined 6-protein predictive biomarker (IL6, IL10, CRP, TNFɑ, FABP-3, and PPY) correctly classified treatment response with 100% accuracy across study arms for REFLECT Phase II trial (AVA100193) and multiple Phase III trials (AVA105640, AV102672, and AVA102670). When the data was combined across all rosiglitazone trial arms, a global RSG-predictive biomarker with the same 6-protein predictive biomarker was able to accurately classify 98%of treatment responders. Conclusion: A predictive biomarker comprising of metabolic and inflammatory markers was highly accurate in identifying those patients most likely to experience positive treatment response across the REFLECT trials. This study provides additional proof-of-concept that a predictive biomarker can be utilized to help with screening and predicting treatment response, which holds tremendous benefit for clinical trials.Item A Review of Dendritic Cell Vaccines in Cancer Treatment and a Managerial Focus on Issues Related to Subject Recruitment(2006-12-01) McFarlin, Tory; Arredondo, LaChelle; Gwirtz, Patricia A.; Oglesby, MichaelMcFarlin, Tory. A Review of Dendritic Cell Vaccines in Cancer Treatment and a Managerial Focus on Issues Related to Subject Recruitment. Master of Science (Clinical Research Management), December 2006, 97 pp., 5 tables, bibliography, 24 titles. Melanoma is form of skin cancer that can become deadly if the cancer progresses to a stage of metastasis. Five year survival rates as low as 10% may be noted in such patients. Decarbazine and Proleukin have been approved by the FDA for the treatment of metastatic melanoma; however both have response rates of approximately 20% or less. New treatment modalities including dendritic cell (DC) vaccines are currently being tested for treating metastatic melanoma with greater safety and efficacy profiles. DC vaccines are made by obtaining a subject’s DCs, priming them with melanoma antigen ex vivo and then injecting them into the patient to initiate an immune response against melanoma tumor cells in vivo. Investigational new treatments such has the DC vaccine must first be tested in clinical trials on research subjects. Subject enrollment issues regarding such a trial can cause delays in advances of the treatment. As an intern with a DC vaccine clinical trial, the author assisted in screening 45 patients and observed many hindrances involving enrollment of subjects. Such hindrances include: low rates of study personnel retention, small patient pools, and competing trials. Recommendations to improve enrollment include: more effective advertisement strategies and increased patient education.Item A Study of the Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for Three Months Versus Daily Isoniazid for Nine Months for the Treatment of Latent Tuberculosis Infection(2004-11-01) Lemp, Jessie; Patricia Gwirtz; Walter McConathy; Richard EasomLemp, Jessie M. A Study of the Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for Three Months Versus Daily Isoniazid for Nine Months for the Treatment of Latent Tuberculosis Infection. Master of Science, November, 2004, 107 pp., 4 tables, 4 figures, references, 29 titles. The standard treatment for latent tuberculosis infection, nine months of daily isoniazid, is effective at preventing active tuberculosis; however, its full benefits are limited by non-adherence. A shorter intermittent regimen of rifapentine plus isoniazid once weekly for three months is equally effective as the standard regimen in animal models. This regimen facilitates the use of directly observed therapy, a method that significantly improves adherence. The Center for Disease Control is sponsoring Study 26 to test the effectiveness and tolerability the three-month rifapentine based regimen in latently infected persons with risk factors for progression to active tuberculosis. This thesis will describe the background rationale and methods for the clinical trial, and the internship experience.Item Clinical Internship with the Anterior Segment Clinical Division at Alcon Laboratories, Inc.: Electronic Data Capture (EDC) Approach vs. Paper-Based Approach to Data Management(2003-11-01) Crout, Danyel C.; Rouel Roque; Judy Vittitoe; Terri PasquineAlthough electronic data capture (EDC) has been available for 20 years or more, companies have remained hesitant about its applicability to enhance clinical trial conduct. Before any company adopts a process that is new to their organization, the procedures and regulations must be practiced and perfected. Pilot trials are developed to gain more knowledge and ease about the proposed process change. Already this year, the clinical data management (CDM) department reported that they have processed over a quarter-million paper case report forms (pCRFs). CDM is an internal component in maintaining clinical trial databases to be used during FDA submissions for approval to market a test article, therefore, data management processes are constantly improved while options are cyclically evaluated. EDC has been recently recognized within Alcon as a possible alternative to improving the efficiency of data collection while simultaneously decreasing data processing time. As a result, this prospective option was compared against the two processes of data management that Alcon currently uses with paper CRFs.Item Comparing Site Management of a NIH versus Industry Sponsored Study: CTSN (Surgical Interventions for Moderate Ischemic Mitral Regurgitation) Trial versus DEEP (Dual Epicardial Endocardial Protocol for Persistent and Longstanding Atrial Fibrillation) Trial(2010-12-01) Ong, Jennifer K.; Patricia GwirtzThe management of a clinical trial requires the coordination of a number of tasks concurrently. Every study has its own individual difficulties and concerns that a research team must work around in order to get a study started and begin subject enrollment. The Baylor Research Institute is participating as a research site for both the CTSN and DEEP studies. Each study is funded by a different type of sponsor, which includes the National Institutes of Health and AtriCure. The two studies were followed from the early stage of site selection up until the point of subject enrollment. The CTSN and DEEP trials provided insight as to how to successfully manage the start-up of both types of studies, demonstrating the delays and difficulties that may arise as a clinical trial agreement approaches execution.Item Evaluation of the Systematic Clinical Trials Protocol Approval Process at a Matrix Cancer Center(2007-11-01) Bloomer, Tyler; Patricia Gwirtz; Rusty Reeves; Lynn BakerThe National Cancer Institute (NCI) estimates that approximately 555,550 people die of cancer each year in the United States. This is an average of a little more than 1,500 people per days and ranks cancer as the second leading cause of death behind heart disease. In 2007, an astonishing 1,444,920 new cancer cases are anticipated to be diagnosed. It is through scientific research and the necessary employment of clinical trials that advanced are made to fight this dreadful disease. A breakthrough or advancement made in the treatment of cancer begins with basic research of cells and tissues in the laboratory. Once a particular treatment or technique is developed, and proven to be successful in animal models, it can then be evaluated in people through clinical trials. Clinical trials follow a rigorous scientific process to answer specific questions relating to the new newly developed therapy or technique. A clinical trial is the only mechanism to determine the true effectiveness of a promising new therapeutic being investigated. Thus, any unnecessary delays in approving a clinical trial protocol increases the time before that trial can begin enrolling patients and therefore gain approval for new treatment options. The International Conference of Harmonization Good Clinical Practice (ICH GCP) guidance document defines a protocol as “a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.” The ICH GCP further goes on to describe that the protocol gives the rationale and background for a trial. The World Health Organization’s (WHO) Handbook for Good Clinical Research Practice states that “the study protocol is the core document communicating trial requirements to all parties who have responsibility to all parties who have responsibility for approval, conduct, oversight, and analysis of the research.” Thus, before any trial can begin accruing patients, its protocol, along with a study’s informed consent, must be thoroughly reviewed and approved by a network of entities to ensure that a study’s protocol outlines a trial that is safe and effective. A recent study conducted at the Vanderbilt-Ingram Cancer Center (VICC) and at a VICC Affiliate Network (VICCAN) sites indicated that two particular processes took longer than all others involved in their clinical trial protocol approval process. These two particular processes were the Scientific Review Committee review process and the Contracts and Grants approval process. This was contrary to what the authors expected, in that, they believed the IRB review and approval process would take the longest. Many of the challenges reported by the authors of the study at the VICC parallel those encountered in the protocol approval process at UT Southwestern. A closer examination of these parameters is needed. The Harold C. Simmons Comprehensive Cancer Center (SCCC) at UT Southwestern Medical Center is a matrix cancer center and relies upon the interactions between other institutions and departments to conduct all phases of its cancer research. Thus, the process involved in approving a clinical trial protocol also rely upon the interactions between other institutions and departments. This is where many challenges and various institutional administrative barriers arise. Therefore, it is the goal of this practicum report to formally evaluate and document the protocol approval process at the SCCC at UT Southwestern. The report will also identify unwarranted time delays in the process and provide feasible resolutions to expediting the overall clinical trial protocol approval process without compromising patient safety or research integrity. At the cessation of this report, a further analysis may be conducted using its findings to determine whether or not these time delays in the process and provide feasible resolutions to expediting the overall clinical trial protocol approval process without compromising patient safety or research integrity. At the cessation of this report, a further analysis may be conducted using its findings to determine whether or not these time delays in approving a study protocol are consistent with approval processes encountered at other institutions and academic health center settings like the Vanderbilt-Ingram Cancer Center and the Simmons Comprehensive Cancer Center.Item Physiologic and Anatomic Changes in Carpal Tunnel Syndrome: Is Osteopathic Manipulative Treatment an Effective Non-Surgical Alternative Therapy?(2005-05-01) White, Heath D.; Williams, Stuart; Cruser, des Anges; Stoll, ScottWhite, Heath D., D.O., M.S. Physiologic and Anatomic Changes in Carpal Tunnel Syndrome: Is Osteopathic Manipulative Treatment an Effective Non-surgical Alternative Therapy? Master of Science (Clinical Research and Education – OMM), May 2005, 110 pp., 4 tables, 5 figures, references, 46 titles. Objective: Carpal tunnel syndrome (CTS), caused by compression of the median nerve within the carpal tunnel, has a prevalence that ranges between 0.53 and 16.3 with medical costs exceeding $2 billion annually. The goal of this clinical trial was to assess for physiologic and anatomic changes in CTS in response to OMT. Physiologic changes were measured with nerve conduction studies (NCS). Anatomic changes were measured with magnetic resonance imaging. Methods: This prospective, randomized, controlled, blinded clinical trial phased to evaluate 50 subjects randomized between two treatment groups, OMT and placebo sub-therapeutic ultrasound. Eligibility criteria included adults between 21 and 70 with a clinical diagnosis of CTS and increased conduction latency of the median nerve. Outcome measures were median motor and sensory conduction distal latencies. Subjects received six treatments. NCS were conducted at entry to the study (baseline), midpoint, and endpoint. Results: Thirty-seven of a planned 50 subjects were randomized to groups. Thirty-one subjects were included in the final data analysis. Preliminary analysis found no significant difference in NCS values over the three testing intervals. Evaluation for effect(s) of multiple treatment providers by analyzing the single treatment provider with the greatest number of subjects found significant improvement in some NCS values for the OMT group. This study was funded by the Osteopathic Research Center, and approved by the UNTHSC Institutional Review Board. Conclusions: The results of this preliminary analysis indicate the possibility for improvement of CTS with OMT, but no conclusive statements about the efficacy of OMT can be made. This preliminary study enabled us to identify multiple areas in the research design and methodology that may be improved, and provides the framework for future studies.Item Presentation of a Sample Case Studies from a Phase 4 Clinical Trial, "Communit-Based Research Assessment Investigating Clobetasol Proplonate 0.05% Spray for the Treatment of Chronic Plaque Psorias - The COBRA Trial"(2008-03-01) Kulkarni, Gopal; Gwritz, Patricia A.; Colon, Luz E.; Johnson, Lori A.Internship Project. Title of the Project. Presentation of Sample Case Studies from phase 4 clinical trial, “Community-Based Research Assessment Investigating Clobetasol Propionate 0.05% Spray for the Treatment of Chronic Plaque Psoriasis- the COBRA trial” Specific Aims. The specific aims of the practicum were to: 1) Select 50 subjects who had photographs available from the Data Listing (database) of the COBRA trial subjects; 2) Collect data for each case from the database provided; 3) Classify the collected data into efficacy, safety, subject satisfaction, compliance and quality of life evaluations; 4) Generate a presentation (slide kit) of the selected case studies for educational and training purposes. Signficance. Case study presentations are a tool to demonstrate the performance of a drug used in a clinical trial. Due to the large scale of the COBRA trial, there was to a need to generate a reference presentation using data belonging to a sample of subjects from the trial. This reference presentation may be useful for educational and training purposes. This chapter describes the process of development of these case study presentations from the data obtained in the COBRA trial.Item Project Management in View of Increasing Sponsor Demands(2006-04-01) Kurschner, Jill Elizabeth; Bens, Annita V.; Kaman, Robert; Arredondo, LaChelleKurschner, Jill E., Project Management in View of Increasing Sponsor Demands. Masters of Clinical Research Management (Biomedical Sciences), April, 2006, 190 pp., 24 tables, bibliography, 27 titles. In an ever increasing environment of Sponsor demands, it is imperative that Contract Research Organizations (CROs) like Company A, provide a niche in which they deliver a clinical trial-related service which is faster, less expensive, and more ingenious than their competitors while still in compliance with federal regulations. Successful project management practices, specifically trial progress tracking tools, are the avenue by which this goal can be achieved. As part of the internship practicum project, two company-wide questionnaires were disseminated to 34 applicable clinical operations employees at Company A. Questionnaire #1 was developed to assess employees’ global views of clinical trial progress tracking. Questionnaire #2 was designed based on the results received from Questionnaire #1. This questionnaire surveyed employees’ ideas and opinions regarding standardization of 5 specific trial progress tracking tools at Company A. Information gathered from the questionnaires will potentially Company A with the implementation of additional standardized trial progress tracking tools.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.