Department of Clinical Development and Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, 500018, India.
Pharmaceut Med. 2024 Mar;38(2):109-120. doi: 10.1007/s40290-024-00518-x. Epub 2024 Mar 7.
Decentralised clinical trials (DCTs) encompass various terms such as virtual, home-based, remote and siteless trials. The objectives of DCTs are to enhance the ease of participation for patients in clinical trials by minimising or removing the necessity for trial subjects to travel to the trial sites. This approach has been shown to reduce drop-out rates, increase study effectiveness and ultimately get life-altering drugs to market faster-saving sponsors billions. At the outset, DCTs deploy a wide range of digital technologies to collect safety and efficacy data from study participants, providing study treatments and performing investigations from the comfort of the patient's own home. The aim of decentralised trials includes patient centricity, enhanced efficacy in clinical trial conduct and generating real-world data. This is done by not only making it convenient for the patient to participate in the trial execution, but also involving them from the planning stage and taking their inputs during designing of trials and consenting documentation, understanding their treatment requirements and designing the studies accordingly. Various regulatory authorities have published guidelines governing DCT principles, especially after the coronavirus disease 2019 (COVID-19) experience of undertaking multicentric clinical trials. Both United States Food and Drug Administration (USFDA) and European Medicines Agency (EMA) have newer, recently updated guidelines to capture this growing reality to undertake clinical trials using patient technology or patient-centric technologies. Other regulatory agencies are accepting data generated using decentralised and patient-centric technologies and making an effort to include elements of decentralised trials in their regulatory guidelines. Decentralised trials follow a hybrid approach to have a balanced mix of remote and in-person data collection and trial procedures. Decentralised and patient-centric approaches are the future of any organisation for the conduct of clinical trials. Globally, all sponsor pharmaceutical companies must start undertaking drug development and clinical trials using a decentralised approach while keeping patient centricity in mind.
去中心化临床试验（DCT）包含各种术语，如虚拟、基于家庭的、远程和无地点试验。DCT 的目的是通过最大限度地减少或消除试验对象前往试验地点的必要性，来提高临床试验中患者参与的便利性。这种方法已被证明可以降低退出率、提高研究效果，并最终更快地将改变生活的药物推向市场——为赞助商节省数十亿美元。
最初，DCT 部署了广泛的数字技术，从研究参与者那里收集安全性和疗效数据，在患者舒适的家中提供研究治疗并进行调查。去中心化试验的目的包括以患者为中心、提高临床试验效果和生成真实世界数据。这不仅使患者更方便地参与试验执行，而且还让他们从规划阶段参与，在试验设计和知情同意文件制定过程中听取他们的意见，了解他们的治疗需求并相应地设计研究。
各种监管机构已经发布了指导去中心化试验原则的指南，尤其是在经历了 2019 年冠状病毒病（COVID-19）的多中心临床试验之后。美国食品和药物管理局（USFDA）和欧洲药品管理局（EMA）都有更新的、最近更新的指南，以捕捉这一日益增长的现实，使用患者技术或以患者为中心的技术进行临床试验。其他监管机构正在接受使用去中心化和以患者为中心的技术生成的数据，并努力在其监管指南中纳入去中心化试验的要素。
去中心化试验采用混合方法，平衡远程和现场数据收集和试验程序。去中心化和以患者为中心的方法是任何组织进行临床试验的未来。在全球范围内，所有赞助制药公司在开展药物开发和临床试验时，必须开始采用去中心化方法，并牢记以患者为中心的理念。
