Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network's PeRSEVERE project.
Background/Aims: Existing regulatory and ethical guidance does not address real-life complexities in how clinical trial participants' level of participation may change. If these complexities are inappropriately managed, there may be negative consequences for trial participants and the integrity of t...
| Publicado en: | Clinical Trials Vol. 22; no. 5; pp. 578 - 597 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Sage Publications, Ltd.
Oct2025
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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=188284831&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188284831 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17407745 AB6 jtl: Clinical Trials issn: 17407745 maglogo: N pubinfo: dt: Oct2025 vid: 22 iid: 5 pid: 33180 pub: Sage Publications, Ltd. place: <Blank> artinfo: ui: 188284831 186361707 188284831 188284831 10.1177/17407745251344524 188284831 ppf: 578 ppct: 19 formats: tig: atl: Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network's PeRSEVERE project. aug: au: Cragg, William J Clifton-Hadley, Laura Dearling, Jeremy Dutton, Susan J Gillies, Katie Hardy, Pollyanna Hind, Daniel Holm, Søren Hood, Kerenza Kearney, Anna Lewis, Rebecca Markham, Sarah Moreau, Lauren Pham, Tra My Roberts, Amanda Ruddock, Sharon Sirovica, Mirjana Sohanpal, Ratna Tharmanathan, Puvan Verghis, Rejina affil: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK sug: subj: Consent (Research) Standards Research Dropouts Research Subject Retention Patient Participation Clinical Trials Counseling Human Adult Middle Age Aged Male Female United Kingdom Funding Source Cross Sectional Studies Qualitative Studies Quantitative Studies Exploratory Research Collaboration Research Personnel Surveys Descriptive Statistics Feedback Conceptual Framework Checklists Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Background/Aims: Existing regulatory and ethical guidance does not address real-life complexities in how clinical trial participants' level of participation may change. If these complexities are inappropriately managed, there may be negative consequences for trial participants and the integrity of trials they participate in. These concerns have been highlighted over many years, but there remains no single, comprehensive guidance for managing participation changes in ways that address real-life complexities while maximally promoting participant interests and trial integrity. Motivated by the lack of agreed standards, and observed variability in practice, representatives from academic clinical trials units and linked organisations in the United Kingdom initiated the PeRSEVERE project (PRincipleS for handling end-of-participation EVEnts in clinical trials REsearch) to agree on guiding principles and explore how these principles should be implemented. Methods: We developed the PeRSEVERE principles through discussion and debate within a large, multidisciplinary collaboration, including research professionals and public contributors. We took an inclusive approach to drafting the principles, incorporating new ideas if they were within project scope. Our draft principles were scrutinised through an international consultation survey which focussed on the principles' clarity, feasibility, novelty and acceptability. Survey responses were analysed descriptively (for category questions) and using a combination of deductive and inductive analysis (for open questions). We used predefined rules to guide feedback handling. After finalising the principles, we developed accompanying implementation guidance from several sources. Results: In total, 280 people from 9 countries took part in the consultation survey. Feedback showed strong support for the principles with 96% of respondents agreeing with the principles' key messages. Based on our predefined rules, it was not necessary to amend our draft principles, but comments were nonetheless used to enhance the final project outputs. Our 17 finalised principles comprise 7 fundamental, 'overarching' principles, 6 about trial design and setup, 2 covering data collection and monitoring, and 2 on trial analysis and reporting. Conclusion: We devised a comprehensive set of guiding principles, with detailed practical recommendations, to aid the management of clinical trial participation changes, building on existing ethical and regulatory texts. Our outputs reflect the contributions of a substantial number of individuals, including public contributors and research professionals with various specialisms. This lends weight to our recommendations, which have implications for everyone who designs, funds, conducts, oversees or participates in trials. We suggest our principles could lead to improved standards in clinical trials and better experiences for participants. We encourage others to build on our work to explore the application of these ideas in other settings and to generate empirical evidence to support best practice in this area. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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