Background/Aims:

Participants are integral to the success of any clinical research study, yet participant recruitment into clinical trials poses ongoing and complex challenges. It is widely accepted and recognised that clinical trial sites often find it difficult to meet recruitment goals, both in terms of accrual targets and timelines. This can impact the validity of trials or cause major delays for research. There are very few frameworks available to clinical trial sites to improve recruitment. The GREET project (Guidance to Recruitment: Examining Experiences at clinical Trial sites) sought to identify barriers to recruitment and produce formal guidance to optimise recruitment outcomes.

Methods:

Clinical Trials: Impact and Quality, a collaborative of sector stakeholders, convened a project team with comprehensive knowledge of the Australian clinical trials sector to undertake the GREET project. The project scope included exploration of recruitment issues at a site level across all phases of clinical trials and all types of trial sites. The scope excluded upstream issues such as protocol design and general public clinical trial awareness, participant retention and elements of recruitment outside a site’s capacity to directly influence or control. The project team’s extensive knowledge and experience conducting clinical trials in Australia was used to collaboratively identify a list of 24 key barriers and 12 enablers to site recruitment which formed the basis of the project. Key stakeholder groups were surveyed to challenge project team assumptions. A national and international environmental scan and literature review was conducted to identify best-practice recruitment solutions.

Results:

A total of 343 people responded to a survey sent to sites, sponsors, and contract research organisations, and 162 people responded to a survey sent to consumers via consumer networks. The key barriers and enablers initially identified by the project team aligned with the key outcomes of the surveys, which in turn assisted in the development of best-practice recommendations in the form of a Clinical Trial Site Recruitment Guide. Recommendations were grouped into four key themes; conducting accurate study feasibility; proactive planning during start-up; selecting optimal recruitment methods; and participant involvement. Early intervention was identified as a key facilitator in maximising improved recruitment outcomes. The GREET Clinical Trial Site Recruitment Guide is publicly accessible on the Clinical Trials: Impact and Quality website.

Conclusion:

Participant recruitment challenges experienced at a site level are widespread and varied, and there is no universal recruitment solution. However, this project identified that there are interventions and assessments that can be proactively implemented and selectively applied to facilitate improved recruitment outcomes.

中文翻译：

---

临床试验站点招募优化：来自临床试验的指导：影响和质量

背景/目标：

参与者对于任何临床研究的成功都是不可或缺的，但参与者招募到临床试验中会带来持续和复杂的挑战。人们普遍接受并认识到，临床试验场所通常难以实现招募目标，无论是在应计目标还是时间表方面。这可能会影响试验的有效性或导致研究的重大延误。可用于临床试验站点以改进招募的框架很少。GREET 项目（招聘指南：临床试验场所的检查经验）旨在确定招聘障碍并制定正式指南以优化招聘结果。

方法：

临床试验：影响和质量，由部门利益相关者合作，召集了一个对澳大利亚临床试验部门有全面了解的项目团队来承担 GREET 项目。项目范围包括在临床试验的所有阶段和所有类型的试验场地的场地级别探索招募问题。该范围不包括上游问题，例如方案设计和一般公众临床试验意识、参与者保留和站点直接影响或控制能力之外的招募要素。项目团队利用在澳大利亚进行临床试验的广泛知识和经验，共同确定了 24 个关键障碍和 12 个站点招募促成因素的清单，这些因素构成了该项目的基础。对主要利益相关者群体进行了调查，以挑战项目团队的假设。进行了国家和国际环境扫描和文献审查，以确定最佳实践招聘解决方案。

结果：

共有 343 人对发送给网站、赞助商和合同研究组织的调查做出回应，162 人对通过消费者网络发送给消费者的调查做出回应。项目团队最初确定的主要障碍和促成因素与调查的主要结果一致，这反过来又有助于以临床试验站点招募指南的形式制定最佳实践建议。建议分为四个关键主题；进行准确的研究可行性；启动期间的主动规划；选择最佳招聘方式；和参与者的参与。早期干预被确定为最大限度地改善招募结果的关键促进因素。GREET 临床试验站点招募指南可在“临床试验：影响和质量”网站上公开访问。

结论：

在站点级别遇到的参与者招聘挑战广泛且多样，并且没有通用的招聘解决方案。但是，该项目确定了可以主动实施和有选择地应用的干预措施和评估，以促进改善招聘结果。