The role of the research nurse in clinical trials

Abstract

Clinical trials are one of the important tools leading to progress in health care and a part of clinical practice. Indispensable support to research teams is provided by research nurses responsible for managing the care for subjects enrolled in clinical trials. The objective was to assess the actual job duties of general nurses participating in clinical trials and to identify the main obstacles and expectations from their point of view. A method of questionnaire survey administered to a selected group of respondents was used. Eight teaching hospitals and two specialized centres in the Czech Republic were approached that are currently carrying out clinical trials. Eight health care providers participated in the survey. Of the total of 10,603 general nurses working at the eight facilities involved in the study, 203 nurses working in research participated in the survey. The data analysis revealed insufficient education in research being the main shortage and limitation for research nurses (74.4%). The majority of nurses were expected to develop professionally when being involved in clinical trials (69.0%). No difference was established in expectations as far as the socio-demographic characteristics of respondents were concerned (p≥0.05). Nurses having attended GCP (Good Clinical Practice) courses perceived their work as more time consuming (p=0.022). The results of the survey have shown that the framework job description of research nurses in clinical trials is insufficiently prepared. The key practical outcome of the study will be educational recommendations and the initiation of a professional discussion on the governmental level on the legislative definition of the position of research nurses in Central Europe and the Czech Republic.