Introduction:

Feasibility evaluations are performed to create the best possible starting point for the set-up and execution of a clinical trial, and to identify any obstacles for successful trial conduct. New digital technologies can provide various types of data for use in feasibility evaluations. There is a need to identify and compare such data sources for trial site identification and for evaluating the sites’ patient recruitment potential. Especially, information is needed on the use of electronic health records. We investigated how different data sources are used by pharmaceutical companies operating in the Nordic countries for identifying trial sites and for evaluating their potential to recruit trial participants.

Methods:

This was a semi-structured qualitative interview study with 21 participants from pharmaceutical companies and contract research organizations operating in Finland, Sweden, Denmark and Norway. Qualitative content analysis was applied.

Results:

For identifying countries and trial sites on a global level, the trial sponsors mostly used databases on previous trial performance. The use of electronic health record data was very limited. Sites’ and investigators’ visibility in various databases was seen as fundamental for their countries becoming selected into new clinical trials. For estimating the sites’ recruitment projections, most sites were seen to base their patient count estimates solely on their previous experience. Some sites had reviewed their electronic health record data, which was considered to increase the accuracy of their recruitment estimates and these sites’ attractivity. Along with dialogs with investigators, the sponsors used various data sources to validate the investigators’ estimates. Legislative obstacles were seen to hinder the use of electronic health record queries for estimation of patient counts.

Conclusion:

Visibility in the databases used by trial sponsors is crucial for the countries and sites to be identified. Site selection appears to be based on trust and relationships built from experience, but electronic data provide the support upon which the trust is based. Estimation of the number of potential trial participants is a complex and time-consuming process for both investigators and sponsors. Sponsors seem to favour sites who could support their patient count estimates with electronic health record data as they were quicker in providing the estimates and more reliable than sites with no electronic health record evidence. The patient count evaluation process could be simplified, accelerated and made more reliable with more systematic use of electronic health record evidence in the feasibility evaluation phase. This would increase the accuracy of the patient count estimates and, on its part, contribute to improved recruitment success.

中文翻译：

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临床试验地点识别实践和电子健康记录在可行性评估中的使用：北欧国家的访谈研究

介绍：

进行可行性评估是为了为临床试验的设置和执行创造最佳的起点，并找出成功进行试验的任何障碍。新的数字技术可以提供各种类型的数据用于可行性评估。需要识别和比较此类数据源，以识别试验地点并评估试验地点的患者招募潜力。特别是，需要有关电子健康记录使用的信息。我们调查了在北欧国家运营的制药公司如何使用不同的数据源来确定试验地点并评估其招募试验参与者的潜力。

方法：

这是一项半结构化定性访谈研究，参与者来自芬兰、瑞典、丹麦和挪威的制药公司和合同研究组织的 21 名参与者。应用定性内容分析。

结果：

为了在全球范围内确定国家和试验地点，试验申办者主要使用先前试验表现的数据库。电子健康记录数据的使用非常有限。站点和研究人员在各种数据库中的可见性被视为其国家被选入新临床试验的基础。为了估计站点的招募预测，大多数站点仅根据其以前的经验来估计患者数量。一些网站审查了其电子健康记录数据，这被认为可以提高其招聘估计的准确性和这些网站的吸引力。除了与研究人员对话外，申办者还使用各种数据源来验证研究人员的估计。人们认为立法障碍阻碍了使用电子健康记录查询来估计患者人数。

结论：

试验申办者使用的数据库的可见性对于确定国家和地点至关重要。选址似乎是基于信任和经验建立的关系，但电子数据提供了信任所依据的支持。对于研究者和申办者来说，估计潜在试验参与者的数量是一个复杂且耗时的过程。申办者似乎更青睐能够通过电子健康记录数据支持其患者计数估计的网站，因为它们提供估计的速度更快，并且比没有电子健康记录证据的网站更可靠。通过在可行性评估阶段更系统地使用电子健康记录证据，可以简化、加速患者计数评估过程并使其更加可靠。这将提高患者计数估计的准确性，并有助于提高招募成功率。