Browsing by Subject "enrollment"
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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 Implementation of a Pain Management Protocol in Abdominal Surgery Patients Involving an Investigational Fentanyl Patient-Controlled Transdermal System--Issues Involving Patient Enrollment(2005-05-01) Hiraki, Stephanie J.; Harold Sheedlo; Don Peska; John AschenbrennerHiraki, Stephanie J., Implementation of a Pain Management Protocol in Abdominal Surgery Patients Involving an Investigational Fentanyl Patient-Controlled Transdermal System-Issues Involving Patient Enrollment. Master of Science (Clinical Research Management), May 2005, 112 pp., 2 tables, 6 illustrations, bibliography, 42 titles. An open label, randomized, comparative, parallel, phase III multicenter study will be the main focus in the surgery department at the University of North Texas Health Science Center Patient Care Center. The study will evaluate the safety and efficacy of the fentanyl patient-controlled transdermal system (PCTS) versus an intravenous patient controlled anesthesia morphine pump (PCA pump) for abdominal surgery postoperative pain management. Patient enrollment is essential. Slow patient enrollment in clinical trials will lead to a delay in the sponsor’s submission of the investigational product for review and approval from the FDA. The barriers and facilitators to the accrual and retention of patients in this study will be covered.