Introduction Many respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers. Methods A respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP. Results On integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence. Discussion Integrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial. Data are available upon request

中文翻译：

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将试验纳入临床护理途径后招募人数增加：一项观察性研究

简介 许多呼吸系统临床试验未能达到他们的招募目标，这个问题加剧了现有的资金问题。将临床试验招募流程整合到临床护理途径 (CCP) 中可能是显着增加招募人数的有效方式。方法 于 2021 年 1 月 11 日成立了呼吸支持部门和用于上报重症 COVID-19 患者的 CCP。同日，将 COVID-19 治疗-呼吸支持试验随机评估的招募流程整合到 CCP 中。该试验的招募数据是在融入 CCP 之前和之后收集的。结果 将招聘流程整合到 CCP 后，招聘人数显着增加。在此过程发生前的 266 天内招募了 50 名患者，而在此过程发生后的 49 天内招募了 108 名患者。相对于 COVID-19 住院人数（从 2.8% 到 9.1%，p<0.0001）和强化治疗单元入院（从 17.8% 到 50.2%， p<0.001）在同一时期，表明这种招募的增加与 COVID-19 的流行无关。讨论 将试验招募流程整合到 CCP 中可以显着提高招募人数。这代表了一种创新模型，可用于在不影响与呼吸临床试验运行相关的财务和劳动力成本的情况下最大化招募。可根据要求提供数据 相对于 COVID-19 住院人数（从 2.8% 到 9.1%，p<0.0001）和强化治疗单元入院（从 17.8% 到 50.2%， p<0.001）在同一时期，表明这种招募的增加与 COVID-19 的流行无关。讨论 将试验招募流程整合到 CCP 中可以显着提高招募人数。这代表了一种创新模型，可用于在不影响与呼吸临床试验运行相关的财务和劳动力成本的情况下最大化招募。可根据要求提供数据 相对于 COVID-19 住院人数（从 2.8% 到 9.1%，p<0.0001）和强化治疗单元入院（从 17.8% 到 50.2%， p<0.001）在同一时期，表明这种招募的增加与 COVID-19 的流行无关。讨论 将试验招募流程整合到 CCP 中可以显着提高招募人数。这代表了一种创新模型，可用于在不影响与呼吸临床试验运行相关的财务和劳动力成本的情况下最大化招募。可根据要求提供数据 表明这种招募的增加与 COVID-19 的流行无关。讨论 将试验招募流程整合到 CCP 中可以显着提高招募人数。这代表了一种创新模型，可用于在不影响与呼吸临床试验运行相关的财务和劳动力成本的情况下最大化招募。可根据要求提供数据 表明这种招募的增加与 COVID-19 的流行无关。讨论 将试验招募流程整合到 CCP 中可以显着提高招募人数。这代表了一种创新模型，可用于在不影响与呼吸临床试验运行相关的财务和劳动力成本的情况下最大化招募。可根据要求提供数据