Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative
Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative
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DOI：
10.1016/j.cct.2018.01.003
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发表时间：
2018-03-01
影响因子：
2.2
通讯作者：
Roberts, Jamie N.
中科院分区：
文献类型：
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作者：
Huang, Grant D.;Bull, Jonca;Roberts, Jamie N.
患者招募被广泛认为是临床试验成功的关键决定因素。然而，大量试验未能达到招募目标，这种情况具有重要的科学、财务、伦理和政策影响。此外，对直接参与试验的利益相关者（包括研究者、申办者和研究参与者）也有重要影响。尽管几十年来努力识别和解决障碍，招募挑战仍然存在。为了推进更全面的试验招募方法，临床试验转型计划 (CTTI) 召集了一个项目团队来研究挑战，并提出可操作的、基于证据的建议，以改进招募计划，这些建议超出了常见的研究特定策略。我们描述了我们的多方利益相关者为开发一个框架而做出的努力，该框架描绘了战略招募规划工作所必需的三个领域：（1）试验设计和方案开发，（2）试验可行性和地点选择，以及（3）沟通。我们的建议提出了一种上游招聘规划方法，有可能产生更大的影响并减少下游障碍。此外，我们还提供工具来帮助促进建议的采用。我们希望我们的框架和建议能够作为临床试验招募计划初步工作的指南，无论疾病或干预重点如何，为该领域的讨论提供共同基础，并为进一步分析和持续改进制定目标。
Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist.To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement.