Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen AB252ZD, UK.
Trials. 2011 Mar 11;12:74. doi: 10.1186/1745-6215-12-74.
Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies.Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques.We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.
随机对照试验（RCT）通常被认为是评估医疗干预措施的金标准。然而，试验效果估计的不确定性程度通常与试验在招募和保留参与者方面的成功程度有关。由于招募通常比预期的慢或更困难，许多试验未能在最初设想的时间和资金范围内达到目标样本量，因此结果往往不如预期可靠。许多试验需要延长招募期才能达到所需的样本量，这可能会延迟更有效的治疗方法在常规临床实践中的应用。此外，由于资源被重新用于延长现有试验，而不是为额外的研究提供资金，因此可能会进行更少的研究。公众资助的 RCT 招募不足的问题已经引起了广泛的讨论，但对于为什么许多试验未能很好地招募参与者、哪些招募方法有效、在哪些人群和环境中有效以及对哪种类型的干预措施有效，仍然缺乏明确的证据。提高招募和保留率的一种解决方案是借鉴商业领域的方法来为试验管理技术提供信息和结构。我们回顾了关于提高试验招募的干预措施。我们描述了一种拟议的临床试验商业方法，并讨论了使用商业模型的实施情况，利用从三个案例研究中获得的见解。
