| Learning Objective #1: Describe the dual goals of clinical trials research | |||
| Learning Objective #2: Articulate the importance of transdisciplinary collaboration in the development of medical devices and related clinical trials |
The dual goals of clinical trials research are to determine the effectiveness of medical device and/or pharmaceutical interventions and to identify additional explanatory factors related to mechanisms of disease processes. For nurses, at both staff and advanced practice levels, involvement in clinical trials research can be an exciting opportunity to improve health care by moving medical devices and pharmaceuticals from the laboratory to those patients who need them. For biomedical engineering students, participation in medical device start-up design and improvement can be a professionally stimulating point of entry into the world of patient clinical transactions.
In this presentation, the directors of the first School of Nursing-based Center for Clinical Trials and Medical Device Evaluation in the United States will articulate nursing's essential contribution to clinical trials research. A description of an innovative transdisciplinary academic relationship between the School of Nursing and the Department of Biomedical Engineering will be used to illustrate the importance of collaboration in the emerging field of clinical trials research, and to demonstrate specialized development opportunities open to health care professionals who are willing to transcend the mold of traditional roles.
Via an anecdotal/case study format, foundational elements of clinical trials research, qualifications of investigators and study staff, the role of Institutional Review Boards, study design and logistics, budgets, subject selection, informed consent, subject compliance, and quality improvements and quality control will be described. FDA definitions of pharmaceuticals and medical devices will be provided, and cGMPs (Current Good Manufacturing Practices) will be discussed. Descriptions of research roles for nurses at all levels of practice, as well as portrayals of opportunities for scholarly collaboration with related academic disciplines, will be integrated throughout this discussion. Via examination of the research processes that underlie health improvement, novel career opportunities for provision of high-quality patient care will be identified and explored.
Back to Collaborative Health Initiatives
Back to 37th Biennial Convention - Clinical Sessions
Sigma Theta Tau International