临床试验中的权力下放和以患者为中心:益处与挑战。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Medicine Pub Date : 2024-03-01 Epub Date: 2024-03-07 DOI:10.1007/s40290-024-00518-x
Shubhadeep D Sinha, Sreenivasa Chary Sriramadasu, Ruby Raphael, Sudeshna Roy
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引用次数: 0

摘要

分散临床试验(DCT)包括虚拟试验、家庭试验、远程试验和无地点试验等多种术语。分散临床试验的目的是通过尽量减少或消除受试者前往试验地点的必要性,为患者参与临床试验提供更多便利。事实证明,这种方法可以降低退出率,提高研究效果,并最终使改变生命的药物更快上市,为赞助商节省数十亿美元。从一开始,分散式试验就利用各种数字技术收集研究参与者的安全性和有效性数据,在患者家中提供研究治疗并进行调查。分散试验的目的包括以患者为中心、提高临床试验的效率和生成真实世界的数据。要做到这一点,不仅要方便患者参与试验的执行,还要让他们从计划阶段就参与进来,在设计试验和同意文件时听取他们的意见,了解他们的治疗要求,并设计相应的研究。各监管机构已发布了有关 DCT 原则的指导方针,特别是在 2019 年冠状病毒病(COVID-19)的多中心临床试验经验之后。美国食品和药物管理局(USFDA)和欧洲药品管理局(EMA)最近都更新了指导原则,以适应利用患者技术或以患者为中心的技术开展临床试验这一日益增长的现实。其他监管机构正在接受使用分散技术和以患者为中心的技术生成的数据,并努力将分散试验的要素纳入其监管指南。分散试验采用混合方法,以平衡远程和现场数据收集与试验程序的组合。分散和以患者为中心的方法是任何组织开展临床试验的未来趋势。在全球范围内,所有赞助制药公司都必须开始采用分散方法进行药物开发和临床试验,同时牢记以患者为中心。
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Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges.

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.

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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
期刊最新文献
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