Identifying and Overcoming Barriers in Clinical Research Management: A Review of Clinical Trials within an Academic Medical Center

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dc.creatorHatfield, Elisha
dc.date.accessioned2019-08-22T21:41:02Z
dc.date.available2019-08-22T21:41:02Z
dc.date.issued2008-12-01
dc.date.submitted2014-05-13T07:24:05-07:00
dc.description.abstractOver 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.
dc.format.mimetypeapplication/pdf
dc.identifier.urihttps://hdl.handle.net/20.500.12503/29510
dc.language.isoen
dc.provenance.legacyDownloads0
dc.subjectDigestive System
dc.subjectHealth and Medical Administration
dc.subjectHealth Services Administration
dc.subjectHealth Services Research
dc.subjectLaboratory and Basic Science Research
dc.subjectLife Sciences
dc.subjectMedicine and Health Sciences
dc.subjectOther Public Health
dc.subjectPublic Health
dc.subjectClinical research
dc.subjectclinical trials
dc.subjectstandard procedures
dc.subjectGastrointestinal Disease Oriented Team
dc.subjectGI DOT
dc.subjectSimmons Cancer Center Clinical Research Office
dc.subjectstudy management
dc.subjectregulation
dc.subjectfunds
dc.subjectsubject recruitment
dc.subjectbarriers
dc.subjectstudy documentation
dc.subjectoperating procedures
dc.subjectGI
dc.subjectproductivity
dc.subjectefficiency
dc.titleIdentifying and Overcoming Barriers in Clinical Research Management: A Review of Clinical Trials within an Academic Medical Center
dc.typeProfessional Report
dc.type.materialtext
thesis.degree.departmentGraduate School of Biomedical Sciences
thesis.degree.disciplineClinical Research Management
thesis.degree.grantorUniversity of North Texas Health Science Center at Fort Worth
thesis.degree.nameMaster of Science

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