Barge Roland, Floody Patrick
Regeneron Pharmaceuticals, Uxbridge, Middlesex, United Kingdom.
Regeneron Pharmaceuticals, Tarrytown, New York.
Mayo Clin Proc Digit Health. 2025 Mar 3;3(2):100201. doi: 10.1016/j.mcpdig.2025.100201. eCollection 2025 Jun.
To define potential participant and site perceptions of decentralized clinical trials (DCTs).
Two qualitative surveys were conducted between January 2022 and August 2022 to assess current awareness of, and perceptions about, DCTs. The first survey received 141 responses from staff at our clinical trial sites; the second survey received 481 responses from US-based healthy individuals or those living with an illness.
There was a difference in perceptions and willingness between participants and sites toward DCTs. Participants expressed more comfort with hybrid and fully remote trials than did the sites. Site staff were more concerned and less trusting than participants of DCTs; participants' main concerns were regarding practicality and medical safety, whereas the focus for sites was on burden, trust, and security. Both sites and participants expressed confidence in fully remote clinical study activities when they have appropriate support; sites were less tolerant of fully remote clinical study activities if professional support was not provided. Overall, sites were more willing to manage the use of DCT-related technologies than were participants. It is highly likely that participants' willingness to manage DCT technologies relates to the perceived burden of use (ie, willingness decreases as burden or impact on daily life increases). Sponsors, contract research organizations, and DCT vendors generally had positive views on DCTs. However, different stakeholders had different concerns.
These results highlight the need for collaborative research and development of DCTs, as well as a clear DCT framework and regulatory guidance.
明确潜在参与者和研究地点对去中心化临床试验（DCT）的看法。
在2022年1月至2022年8月期间进行了两项定性调查，以评估当前对DCT的认识和看法。第一项调查收到了来自我们临床试验地点工作人员的141份回复；第二项调查收到了来自美国健康个体或患病个体的481份回复。
参与者和研究地点对DCT的看法和意愿存在差异。与研究地点相比，参与者对混合式和完全远程试验表现出更高的舒适度。研究地点的工作人员比DCT的参与者更担忧且信任度更低；参与者主要关注实用性和医疗安全性，而研究地点关注的重点是负担、信任和安全性。当获得适当支持时，研究地点和参与者都对完全远程的临床研究活动表示有信心；如果未提供专业支持，研究地点对完全远程的临床研究活动的容忍度较低。总体而言，研究地点比参与者更愿意管理DCT相关技术的使用。参与者管理DCT技术的意愿很可能与感知到的使用负担有关（即随着负担或对日常生活的影响增加，意愿降低）。申办方、合同研究组织和DCT供应商通常对DCT持积极看法。然而，不同利益相关者有不同的担忧。
这些结果凸显了对DCT进行合作研发的必要性，以及明确的DCT框架和监管指南的必要性。
