Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.
BMJ Open. 2022 Aug 29;12(8):e063236. doi: 10.1136/bmjopen-2022-063236.
Decentralised clinical trial activities-such as participant recruitment via social media, data collection through wearables and direct-to-participant investigational medicinal product (IMP) supply-have the potential to change the way clinical trials (CTs) are conducted and with that to reduce the participation burden and improve generalisability. In this study, we investigated the decentralised and on-site conduct of trial activities as reported in CT protocols with a trial start date in 2019 or 2020.
We ascertained the decentralised and on-site conduct for the following operational trial activities: participant outreach, prescreening, screening, obtaining informed consent, asynchronous communication, participant training, IMP supply, IMP adherence monitoring, CT monitoring, staff training and data collection. Results were compared for the public versus private sponsors, regions involved, trial phases and four time periods (the first and second half of 2019 and 2020, respectively).
Phases 2, 3 and 4 clinical drug trial protocols with a trial start date in 2019 or 2020 available from ClinicalTrials.gov.
The occurrence of decentralised and on-site conduct of the predefined trial activities reported in CT protocols.
For all trial activities, on-site conduct was more frequently reported than decentralised conduct. Decentralised conduct of the individual trial activities was reported in less than 25.6% of the 254 included protocols, except for decentralised data collection, which was reported in 68.9% of the protocols. More specifically, 81.9% of the phase 3 protocols reported decentralised data collection, compared with 73.3% and 47.0% of the phase 2 and 4 protocols, respectively. For several activities, including prescreening, screening and consenting, upward trends in reporting decentralised conduct were visible over time.
Decentralised methods are used in CTs, mainly for data collection, but less frequently for other activities. Sharing best practices and a detailed description in protocols can drive the adoption of decentralised methods.
通过社交媒体招募参与者、通过可穿戴设备收集数据以及直接向参与者提供试验用药品（IMP）等分散临床试验（CT）活动具有改变临床试验进行方式的潜力，从而减轻参与者负担并提高普遍性。在这项研究中，我们调查了 2019 年或 2020 年开始的 CT 方案中报告的分散式和现场进行的试验活动。
我们确定了以下运营试验活动的分散式和现场进行情况：参与者外展、预筛选、筛选、获得知情同意、异步通信、参与者培训、IMP 供应、IMP 依从性监测、CT 监测、员工培训和数据收集。比较了公共和私人赞助商、涉及的地区、试验阶段和四个时间段（2019 年上半年和下半年以及 2020 年上半年和下半年）的结果。
可从 ClinicalTrials.gov 获取 2019 年或 2020 年开始的 2 期、3 期和 4 期临床药物试验方案。
对于所有试验活动，现场进行的情况比分散进行的情况更为常见。在 254 项纳入的方案中，除了分散的数据收集外，不到 25.6%的方案报告了分散式的试验活动。具体而言，81.9%的 3 期方案报告了分散的数据收集，而 2 期和 4 期方案分别为 73.3%和 47.0%。对于一些活动，包括预筛选、筛选和同意书，随着时间的推移，报告分散式进行的情况呈上升趋势。
分散式方法用于 CT，主要用于数据收集，但其他活动的使用频率较低。在方案中分享最佳实践和详细描述可以推动分散式方法的采用。
