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临床试验中的招募与保留原则。

Principles of recruitment and retention in clinical trials.

作者信息

Aitken Leanne, Gallagher Robyn, Madronio Christine

机构信息

Centre for Acute Nursing Interventions, Faculty of Nursing, Midwifery and Health, University of Technology, Sydney, NSW, Australia.

出版信息

Int J Nurs Pract. 2003 Dec;9(6):338-46. doi: 10.1046/j.1440-172x.2003.00449.x.

Abstract

Efficient and effective recruitment and retention of participants is the largest single component of the study workload and forms an essential component in the conduct of clinical trials. In this paper, we present five principles to guide the processes of both recruitment and retention. These principles include the selection of an appropriate population to adequately answer the research question, followed by the establishment of a sampling process that accurately represents that population. Creation of systematic and effective recruitment mechanisms should be supported by implementation of follow-up mechanisms that promote participant retention. Finally, all activities related to recruitment and retention must be conducted within the framework of ethics and privacy regulations. Adherence to these principles will assist the researcher in achieving the goals of the study within the available resources.

摘要

高效且有效地招募和留住参与者是研究工作量中最大的单一组成部分,也是开展临床试验的重要组成部分。在本文中,我们提出了五条原则来指导招募和留住参与者的过程。这些原则包括选择合适的人群以充分回答研究问题,随后建立能准确代表该人群的抽样过程。建立系统且有效的招募机制应辅以促进参与者留存的随访机制。最后,与招募和留住参与者相关的所有活动都必须在伦理和隐私法规的框架内进行。遵循这些原则将有助于研究人员在现有资源范围内实现研究目标。

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