MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK.
trialsathome.com.
Br J Clin Pharmacol. 2022 Mar;88(3):1031-1042. doi: 10.1111/bcp.15003. Epub 2021 Aug 12.
The aim of the study was to identify actionable learning points from stakeholders in remote decentralised clinical trials (RDCTs) to inform their future design and conduct.
Semistructured interviews were carried out with a purposive sample of stakeholders, including senior managers, trial managers, technology experts, principal investigators, clinical investigators, research scientists, research nurses, vendors, patient representatives and project assistants. The interview data were coded using a thematic approach, identifying similarities, differences and clustering to generate descriptive themes. Further refinement of themes was guided by empirical phenomenology, grounding explanation in the meanings that interviewees gave to their experiences.
Forty-eight stakeholders were interviewed. Actionable learning points were generated from the thematic analysis. Patient involvement and participant engagement were seen as critical to the success of RDCTs where in-person contact is minimal or nonexistent. Involving patients in identifying the research question, creating recruitment materials, apps and websites, and providing ongoing feedback to trial participants were regarded as facilitating recruitment and engagement. Building strong relationships early with trial partners was thought to support RDCT conduct. Multiple modes of capturing information, including patient-reported outcomes (PROs) and routinely collected data, were felt to contribute to data completeness. However, RDCTs may transfer trial activity burden onto participants and remote-working research staff, therefore additional support may be needed.
RDCTs will continue to face challenges in implementing novel technologies. However, maximising patient and partner involvement, reducing participant and staff burden, and simplifying how participants and staff interact with the RDCT may facilitate their implementation.
本研究旨在从远程去中心化临床试验（RDCT）的利益相关者中确定可采取行动的学习要点，为其未来的设计和实施提供信息。
采用目的性抽样方法，对包括高级管理人员、试验管理人员、技术专家、主要研究者、临床研究者、研究科学家、研究护士、供应商、患者代表和项目助理在内的利益相关者进行半结构化访谈。使用主题分析方法对访谈数据进行编码，识别相似点、差异点和聚类，以生成描述性主题。通过实证现象学进一步完善主题，将解释建立在受访者对其经验赋予的意义之上。
共访谈了 48 位利益相关者。从主题分析中生成了可采取行动的学习要点。患者参与和参与者参与被认为是 RDCT 成功的关键，在 RDCT 中，面对面的接触很少或不存在。让患者参与确定研究问题、创建招募材料、应用程序和网站，并向试验参与者提供持续反馈，被认为有助于招募和参与。尽早与试验合作伙伴建立牢固的关系被认为有助于 RDCT 的开展。认为多种信息采集方式，包括患者报告的结果（PROs）和常规收集的数据，有助于数据的完整性。然而，RDCT 可能会将试验活动的负担转移给参与者和远程工作的研究人员，因此可能需要额外的支持。
RDCT 在实施新的技术时将继续面临挑战。然而，最大限度地提高患者和合作伙伴的参与度、减轻参与者和工作人员的负担、简化参与者和工作人员与 RDCT 的互动方式，可能有助于 RDCT 的实施。
