Sharma Pooja, Bhowmick Subhrojyoti, Nayak Kedar, Bhattacharjee Soma, Lahiry Sandeep
Chief Executive Officer, APAR Health, Gurgaon, Haryana, India.
Research and Academics Department, Peerless Hospital, Kolkata, West Bengal, India.
Perspect Clin Res. 2024 Apr-Jun;15(2):94-98. doi: 10.4103/picr.picr_218_22. Epub 2023 Dec 6.
There is a need to transition from conventional (on-site) clinical trials (CTs) to trials conducted within the comfort of a patient's home or community (decentralized CT) through e-consent, remote data monitoring, and telemedicine consults. This shift in trial procedures will positively impact recruitment rates, compliance and participant retention, protocol deviations, and delays or missed visits. Home nursing in CTs (HNCTs) will be an important component of this decentralization effort. A few limitations may impact the implementation of HNCT in India. In this regard, the workstream conducted semi-structured qualitative interviews with experts from diverse domains of CT conduct (researchers from academia and industry, clinicians, investigators, nursing staff, patient research advocates, institutional ethics committee, or institutional review board members, legal experts, and trial participants) to collect their understanding, perspectives, and the ground realities about HNCTs in India. The current review puts forth the key areas that would facilitate the establishment of HNCTs in India and provides recommendations for the same.
有必要从传统的（现场）临床试验（CT）过渡到通过电子同意、远程数据监测和远程医疗咨询在患者家中或社区舒适环境中进行的试验（去中心化CT）。试验程序的这种转变将对招募率、依从性和参与者留存率、方案偏差以及延迟或错过访视产生积极影响。临床试验中的家庭护理（HNCT）将是这一去中心化努力的重要组成部分。一些限制因素可能会影响HNCT在印度的实施。在这方面，工作流对来自CT实施不同领域的专家（学术界和行业的研究人员、临床医生、研究者、护理人员、患者研究倡导者、机构伦理委员会或机构审查委员会成员、法律专家和试验参与者）进行了半结构化定性访谈，以收集他们对印度HNCT的理解、观点和实际情况。当前的综述提出了有助于在印度建立HNCT的关键领域，并为此提供了建议。
