Swanson G M, Ward A J
(Department of Anthropology), Michigan State University, East Lansing 48824, USA.
J Natl Cancer Inst. 1995 Dec 6;87(23):1747-59. doi: 10.1093/jnci/87.23.1747.
The purpose of this review is to describe the state of the art in recruiting participants for clinical trials designed to test new methods of treatment or disease prevention. The ultimate objective of this review is to provide a summary of key issues in recruiting diverse populations into clinical trials, particularly ethnic and racial minorities. An overview of general issues related to clinical trial participation is followed by a detailed discussion of specific issues that must be addressed by investigators as they recruit minority populations for clinical trial. To date, the majority of clinical trials have included a limited segment of the U.S. population: middle-class, married white males. These trials have faced many problems in their efforts to recruit participants, including barriers to physician participation, barriers to subject participation, barriers to planning and implementing effective recruitment strategies, and costs of the recruitment phase of clinical trials. Following this general introduction is a discussion of the definition of diverse populations. The first step investigators must take as they prepare to recruit study participants is to develop a relevant definition of the subject populations. A detailed review of investigators' experiences in recruiting minorities into clinical trials is presented, including barriers to minority recruitment, barriers inherent in study design, researcher bias, barriers to minority physician participation, as well as strategies for minority recruitment, modifications of study design, and cost issues. Formal evaluation of recruitment strategies has been limited. Most investigators present descriptive reports of their experience in recruiting diverse populations into clinical trials. Research into the issues presented and rigorous testing of specific strategies is needed. A series of steps that are essential to effective clinical trials recruitment of diverse populations is presented.
本综述的目的是描述在招募参与者进行旨在测试新治疗方法或疾病预防方法的临床试验方面的最新进展。本综述的最终目标是总结在招募不同人群，特别是少数族裔和种族群体参与临床试验方面的关键问题。在概述与参与临床试验相关的一般问题之后，将详细讨论研究人员在招募少数族裔参与临床试验时必须解决的具体问题。迄今为止，大多数临床试验纳入的美国人群范围有限：中产阶级、已婚白人男性。这些试验在招募参与者的过程中面临许多问题，包括医生参与的障碍、受试者参与的障碍、制定和实施有效招募策略的障碍以及临床试验招募阶段的成本。在这一总体介绍之后，将讨论不同人群的定义。研究人员在准备招募研究参与者时必须采取的第一步是制定相关的受试者群体定义。本文将详细回顾研究人员在招募少数族裔参与临床试验方面的经验，包括少数族裔招募的障碍、研究设计中固有的障碍、研究人员的偏见、少数族裔医生参与的障碍，以及少数族裔招募策略、研究设计的修改和成本问题。对招募策略的正式评估一直很有限。大多数研究人员提交了关于他们在招募不同人群参与临床试验方面经验的描述性报告。需要对所提出的问题进行研究并对具体策略进行严格测试。本文还介绍了有效招募不同人群参与临床试验必不可少的一系列步骤。
