Lengacher C A, Gonzalez L L, Giuliano R, Bennett M P, Cox C E, Reintgen D S
College of Nursing, University of South Florida, Tampa, USA.
Oncol Nurs Forum. 2001 Aug;28(7):1115-20.
PURPOSE/OBJECTIVES: To present barriers and strategies related to successful clinical trial participation and integrate them into a model for successful trial participation.
The proposed model was developed based on a literature review related to clinical trial participation, review of empirical studies related to clinical trials, and experiences with subject participation.
Successful clinical trial participation depends on study design, participant factors, issues related to ethnic diversity, the informed consent process, and physician factors.
Clinical trial participation is critical for all disciplines. However, nurses either are researchers or co-investigators with physicians on clinical trials, and it is critical for them to understand specific barriers and success strategies for patient participation. Future studies need to be conducted related to participation in nursing clinical trial research. These study results will facilitate successful nursing clinical trials.
This model can be used in implementation of clinical trials across disciplines prior to and during enrollment of patients into studies.
目的/目标：介绍与成功参与临床试验相关的障碍和策略，并将其整合到一个成功参与试验的模型中。
所提出的模型是基于与临床试验参与相关的文献综述、与临床试验相关的实证研究综述以及受试者参与的经验而开发的。
成功参与临床试验取决于研究设计、参与者因素、与种族多样性相关的问题、知情同意过程以及医生因素。
参与临床试验对所有学科都至关重要。然而，护士要么是临床试验的研究者，要么是与医生共同参与研究的人员，对他们来说，了解患者参与的具体障碍和成功策略至关重要。未来需要开展与参与护理临床试验研究相关的研究。这些研究结果将有助于成功开展护理临床试验。
该模型可在患者纳入研究之前和期间用于跨学科实施临床试验。
