Browsing by Subject "Clinical Trials"
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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 Clinical Project Management Portal Optimization Through Change Management Best Practices(2013-12-01) Moty, Bridget C.; Claire KirchhoffPurpose: The aim of this practicum project was 1) to determine the perceived benefits of, opinion of, and desire to use portals in a CRO; 2) to identify portal upgrade features based on user opinions and suggestions that can enhance communication and increase the transparency of data, and 3) to measure any changes in perceived benefits of, opinion of, and desire to use company portals after demonstration of a proposed upgraded portal model. Hypothesis: Incorporating end users’ input to optimize portal design will (1) elicit more positive opinions about portal technology and its use, and (2) increase end users’ desire to use portal technology in the future Design: A survey was conducted to determine the perception and use of the legacy portal and to specify which processes needed to be simpler to access and use in the portal. Using the results of the first survey, a theoretical upgraded portal presentation was designed. This was shown to the participants of the first survey, who then participated in a second survey which determined the perception and potential use of the upgraded portal and evaluated the ease of access and use of important features in the upgraded portal. Results and Conclusion: After their input was used to design a theoretical upgraded portal system, end users felt more positive towards the new portal and comfortable with adopting and using the upgraded portal.Item Clinical Trial Management Analysis and Integration of New Policies and Procedures Into a Research Department(2013-05-01) Schroedter, Lori L.; Ladislav DoryThe purpose of this practicum was to increase productivity and efficiency in the clinical research department. Using the guidelines set out by the FDA and ICH, the team set out to maintain compliance. The addition of an organizational system will assist the staff in the endeavor of clinical research. Over the course of this internship experience, the research department added new processes, forms, and databases, increased productivity and patient interaction, and decreased the amount of time doing tasks. The main goal of the practicum project was to implement a set of tools to increase organization in the research department. As these tools were developed, they were implemented. After the collection and analysis of the data, it was determined that overall there was a slight increase in the productivity and efficiency with the research personnel. With all of the information working together, it decreased the number of tasks, and the time it took to complete some tasks.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 Effects of Percieved Treament Options on Compleation of Clinical Study Visits in an Obstetrics Study(2009-07-01) Ebo, Joy M.; Patricia GwirtzObjectives: To determine the effects of patient perception on perceived treatment options, and to determine whether distance traveled to receive treatment affects study visit attendance. Methods: Prior to enrolling in the study, patient information was gathered using NextGen, an electronic medical records (EMR) program. Pregnant women between the ages of 18 and 35, inclusive, were selected to participate in the study. The subjects were presented with information about the pregnancy study at their clinic visits verbally and/or via a brochure. Any questions that the patients had were addressed by the clinical research coordinators. Subjects were randomly assigned to one of three different treatment groups – OMT, ultrasound, and standard care. A One-Way ANOVA was conducted to examine the relationship between the visit attendance and the treatment group, clinic group, and distance traveled to receive treatment. Results: Subjects in the three different treatment groups, on average, completed about the same amount of visits and traveled about the same distance to their respective clinics to receive treatment. Research participants from the Harris clinic completed more study visits than research participants from the PCC, even though participants from Harris traveled a further distance from their homes to the clinic. Conclusions: Patient perception of treatment options did not seem to have a significant effect on study visit attendance for the pregnant women involved in this study. Factors that could potentially hinder study visit attendance or clinical research enrollment were discussed; however, factors that effected study visit attendance for the participants were not examined.Item Evaluation of New Operating Procedures for Submitted Investigator-Initiated Research to Baylor's IRB(2013-05-01) Rutter, Taylor M; Claire KirchhoffRutter, Taylor M., Evaluation of New Operating Procedures For Submitting Investigator-Initiated Research to Baylor’s IRB. Master of Science (Clinical Research Management), May, 2013, 97pp., 6 tables, bibliography, 24 titles. Purpose: To create a toolkit for investigator-initiated research outlining the resources available and the necessary steps to submit an application to the BUMC IRB and to make this a more efficient and satisfactory process. Hypothesis: A toolkit for investigator-initiated research that outlines the steps to complete Baylor’s Internal Review Board (IRB) submission process will decrease the timeframe that is needed for IRB approval and decrease the confusion with the application process. Design: A pilot toolkit was designed to aid in the IRB submission process for investigator-initiated research studies. A survey was distributed to toolkit users to gather information about their satisfaction with it and the effect that it had on efficiency. Results: The pilot toolkit was an anticipated item for researchers at Baylor. The packet was helpful and they were satisfied with the product. The preliminary results show that the packet reduced the time needed to obtain IRB approval.Item Factors Responsible For Loss To Follow Up In A Longitudinal StudyComparing Coronary Artery Bypass Surgery And PercutaneousCoronary Intervention(2010-12-01) Vera, Orlando; Patricia GwirtzItem Factors that Impact Patient Enrollment in Clinical Trials(2014-12-01) Duong, Phong; Shi, Xiangrong; Gwirtz, Patricia A.; Lovely, Rehana S.Introduction: Medical progress, now more than ever, demands clinicians to provide tangible proof over sound hypotheses. This is where clinical research steps in as a combatant to the unknown provoked by logical theories and sound hypotheses. The one constant in clinical research is that recruitment strategies are always changing. Analyzing factors that impact recruitment will effectively serve to improve the quality of clinical research conduction. Objective: The purpose of this project is to determine if there are certain factors in an individual’s life that has influenced them to participate in a clinical research study. Methods: To address the specific aims of the practicum project, a fifteen-question survey was administered to subjects enrolled in four different studies at Plaza Medical Center of Fort Worth. Data analysis was conducted using the Chi-Square Significance Test. Results: The data yielded Chi-Square values of 11.355 (Personal Influence), 14.129 (Family Influence), 186.242 (Research Staff influence), 40.581 (Financial Influence), and 56.871(Physician Influence). The values were tested under the following parameters: α=0.05 with four degrees of freedom. Conclusions: This leads to a rejection of the null hypothesis and implies that there are factors in a subject’s life that influences their decision to participate in a research study.Item Identifying barriers to enrollment and strategies to increase enrollment at a community-based cancer treatment center(2014-05-01) Gokul, Sheila R.; Ladislav DoryAlthough clinical trials are essential for the development of cancer treatments, only approximately 3% of cancer patients in the U.S. participate in them. While 55% of these patients are enrolled in cancer clinical trials through community-based practices and around 80% of all cancer patients are seen at this type of practice, there is a lack of knowledge about the enrollment barriers at these sites. This study evaluates enrollment barriers at a community-based cancer clinic at the levels of the investigative site, healthcare provider, and patient. Barriers to enrollment and strategies to increase enrollment are evaluated through historical data analyses and results from a survey assessing the opinions of healthcare providers on enrollment and research practices.Item Recruitment, Retention and Compliance in Randomized, Phase III Clinical Trials Involving Obese Patients Diagnosed with Type 2 Diabetes Mellitus with Respect to Weight Loss.(2012-12-01) Mithani, Moez S.; Robert WordingerHuman research and clinical trials face many obstacles that prevent or hinder efficient and reliable data and results from being collected, analyzed, and reported. This is especially true in clinical trials involving type 2 diabetes. The purpose of this study is to understand issues relating to the recruitment, retention, and compliance of Type 2 diabetic subjects in phase III clinical trials. The data used in this study was collected from a parent study already conducted at the investigator site. The results indicate that issues with recruitment are attributed primarily to the inclusion/exclusion criteria, especially HbA1c values and changes in medication usage. Decreases in retention were primarily due to a lack of involvement in the control group on part of the subject and the coordinator and also due to a lack of significant results in a timely manner. Issues with compliance were found to be due to a lack of discipline on the part of the subject to make lifestyle adjustments and a lack of time in the daily schedule to add an exercise program and employ healthy dieting regimen.Item Use of Social Media and its Potential for Subject Recruitment in Clinical Trials.(2014-05-01) Reyes, Mario C.; Jerry SimeckaEffective research subject recruitment is crucial for clinical trial success. Low enrollment prolongs clinical trials and delays researchers from determining the safety and efficacy of new medical devices or drugs. The goal of this thesis was to survey the patient community at the University of North Texas Health Science Center to determine their views and knowledge on social media and the effectiveness of social media as a potential platform for subject recruitment. The research questions were aimed at identifying factors that motivate potential research subjects to participate in clinical trials. The results showed individuals were less likely to participate in a clinical trial via social media advertisements. The preferred recruitment method selected was a physician’s referral across all of the groups compared. The conclusion proposes that a physician’s participation is essential in recruiting subjects for clinical trials. The current study was limited by a single center cohort. Future studies will require a secondary subject pool.