Recruiting and retaining participants in a combined behavioral and pharmacological clinical trial.

Allen Zweben, David Barrett, Lisa Berger, Kelly Tobin Murray
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引用次数: 16

Abstract

OBJECTIVE This article focuses on the practical and methodological considerations that went into recruiting and retaining participants in a complex clinical trial. It describes multiple recruitment strategies that were employed to meet stringent eligibility criteria and manage efficiently the flow of participants to fulfill recruitment goals. Both study-wide and site-specific methods that were employed to maximize retention rates are discussed. Also discussed is how the coordinating center worked together with study investigators to improve recruitment and retention. METHOD A multidimensional perspective on recruitment and retention is discussed. Details are provided on how barriers to recruitment and retention were addressed. Intervention strategies designed by the coordinating center to meet performance goals are described. Data are presented to support the utility of recruitment and retention methods. The COMBINE Study served as a case illustration for various issues addressed in the article. RESULTS As a result of the combined efforts of the coordinating center and study sites, there was steady improvement in recruitment and retention rates over the course of the trial. The recruitment goal of 1,375 participants was surpassed by September 2003. Also, improvement in data completeness rates improved by 18-27 percentage points over a 3-year period, culminating in follow-up rates meeting or exceeding performance goals by 2004. CONCLUSIONS Various strategies and procedures designed to address recruitment and retention problems in large, complex combination pharmacotherapy and behavioral trials were effective in meeting recruitment and retention goals. The lessons learned may be of value to investigators not only involved in multisite, combination trials but in monotherapy and/or single-site studies as well.
招募并留住行为与药理学联合临床试验的参与者。
目的:这篇文章的重点是实际和方法学上的考虑,进入招募和保留参与者在一个复杂的临床试验。它描述了多种招聘策略,这些策略被用来满足严格的资格标准,并有效地管理参与者的流动,以实现招聘目标。研究范围内和特定地点的方法,以最大限度地提高保留率进行了讨论。还讨论了协调中心如何与研究调查人员一起工作,以改善招聘和保留。方法:从多维角度对招聘与留用问题进行探讨。详细介绍了如何解决征聘和留用方面的障碍。描述了协调中心为满足绩效目标而设计的干预策略。提出了数据来支持招聘和保留方法的效用。COMBINE研究作为文章中讨论的各种问题的案例说明。结果:由于协调中心和研究地点的共同努力,在试验过程中,招募率和保留率稳步提高。截至2003年9月,已超额完成招募1375人的目标。此外,数据完成率在3年期间提高了18-27个百分点,到2004年达到或超过业绩目标的后续完成率达到顶峰。结论:在大型、复杂的联合药物治疗和行为试验中,用于解决招募和保留问题的各种策略和程序在满足招募和保留目标方面是有效的。从中吸取的经验教训可能不仅对参与多地点联合试验的研究人员有价值,而且对单点治疗和/或单点研究也有价值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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