Huynh Lynn, Johns Benjamin, Liu Su-Hsun, Vedula S Swaroop, Li Tianjing, Puhan Milo A
Analysis Group, Inc., Boston, MA, USA
Department of International Health, Abt Associates, Inc., Bethesda, MD, USA.
Clin Trials. 2014 Oct;11(5):576-83. doi: 10.1177/1740774514540371. Epub 2014 Jun 30.
A large fraction of the cost of conducting clinical trials is allocated to recruitment of participants. A synthesis of findings from studies that evaluate the cost and effectiveness of different recruitment strategies will inform investigators in designing cost-efficient clinical trials.
To systematically identify, assess, and synthesize evidence from published comparisons of the cost and yield of strategies for recruitment of participants to health research studies.
We included randomized studies in which two or more strategies for recruitment of participants had been compared. We focused our economic evaluation on studies that randomized participants to different recruitment strategies.
We identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to clinical trials. We found that allocating additional resources to recruit participants using monetary incentives or direct contact yielded between 4% and 23% additional participants compared to using neither strategy. For medical referral, recruitment of prostate cancer patients by nurses was cost-saving compared to recruitment by consultant urologists. For all underlying study designs, monetary incentives cost more than direct contact with potential participants, with a median incremental cost per recruitment ratio of Int$72 (Int$-International dollar, a theoretical unit of currency) for monetary incentive strategy compared to Int$28 for direct contact strategy. Only monetary incentives and source of referral were evaluated for recruiting participants into clinical trials.
We did not review studies that presented non-monetary cost or lost opportunity cost. We did not adjust for the number of study recruitment sites or the study duration in our economic evaluation analysis.
Systematic and explicit reporting of cost and effectiveness of recruitment strategies from randomized comparisons is required to aid investigators to select cost-efficient strategies for recruiting participants to health research studies including clinical trials.
开展临床试验的很大一部分成本用于招募参与者。对评估不同招募策略的成本和效果的研究结果进行综合分析,将为研究人员设计具有成本效益的临床试验提供参考。
系统地识别、评估和综合已发表的关于健康研究参与者招募策略的成本和招募率比较的证据。
我们纳入了比较两种或更多参与者招募策略的随机研究。我们将经济评估重点放在将参与者随机分配到不同招募策略的研究上。
我们识别出10项比较招募策略的随机研究,包括金钱激励(现金或奖品)、直接接触(信件或电话)和医疗转诊策略。10项研究中只有两项比较了招募临床试验参与者的策略。我们发现,与不使用任何策略相比,分配额外资源采用金钱激励或直接接触策略招募参与者,可多招募4%至23%的参与者。对于医疗转诊,护士招募前列腺癌患者比泌尿外科顾问医生招募更节省成本。对于所有基础研究设计,金钱激励的成本高于与潜在参与者直接接触,金钱激励策略的每次招募增量成本中位数为国际元72(国际元是一种理论货币单位),而直接接触策略为28国际元。在招募临床试验参与者方面,仅对金钱激励和转诊来源进行了评估。
我们未审查呈现非货币成本或机会成本损失的研究。在经济评估分析中,我们未对研究招募地点数量或研究持续时间进行调整。
需要对随机比较中的招募策略成本和效果进行系统且明确的报告,以帮助研究人员选择具有成本效益的策略来招募包括临床试验在内的健康研究参与者。