Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials.
The expansion of the use of decentralised elements in clinical trials in the European Union is driven by the opportunities they offer, including their potential to enhance trial access and improve research outcomes. Despite these potential benefits, several regulatory, operational, and technological...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 59; no. 6; pp. 1211 - 1219 |
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| Autores principales: | , , , , , |
| Formato: | practice guidelines tables/charts Journal Article |
| Publicado: |
Springer Nature
Nov2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=189054753&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 189054753 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: Nov2025 vid: 59 iid: 6 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 189054753 185441677 189054753 189054753 10.1007/s43441-025-00796-w 189054753 ppf: 1211 ppct: 8 formats: tig: atl: Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials. aug: au: Bond, Alison Robertson, Tracey Fletcher, Christine Theogaraj, Elizabeth Jordinson, Greg Askin, Scott affil: https://ror.org/02gvvc992 Director, Global Regulatory Policy and Intelligence, Amgen Ltd, 4 Uxbridge Business Park, Sanderson Road, UB8 1DH, Uxbridge, United Kingdom sug: subj: Practice Guidelines Clinical Trials Standards Research Subjects Telemedicine Data Collection European Union Diversity, Equity, Inclusion Diffusion of Innovation Rare Diseases ab: The expansion of the use of decentralised elements in clinical trials in the European Union is driven by the opportunities they offer, including their potential to enhance trial access and improve research outcomes. Despite these potential benefits, several regulatory, operational, and technological challenges impede their widespread adoption. This paper, developed by members of the European Federation of Pharmaceutical Industries and Associations, proposes strategies and policy recommendations to overcome these barriers. Through harmonised regulatory frameworks, improved data validation methods, and increased stakeholder collaboration, the use of decentralised elements could become a standard practice in clinical research as part of the clinical trial toolbox to be deployed as appropriate, thereby enabling innovation and allowing for equitable access to clinical trials for diverse populations. pubtype: Academic Journal doctype: practice guidelines tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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