eprintid: 10043309 rev_number: 28 eprint_status: archive userid: 608 dir: disk0/10/04/33/09 datestamp: 2018-02-13 14:04:20 lastmod: 2021-12-13 03:04:48 status_changed: 2018-02-13 14:04:20 type: article metadata_visibility: show creators_name: Vale, CL creators_name: Cragg, WJ creators_name: Cromarty, B creators_name: Hanley, B creators_name: South, A creators_name: Stephens, R creators_name: Sturgeon, K creators_name: Gafos, M title: When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL ispublished: pub divisions: UCL divisions: B02 divisions: D65 divisions: J38 note: Copyright © The Author(s) 2018. Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. abstract: BACKGROUND: Patient and public involvement (PPI) in clinical trials aims to ensure that research is carried out collaboratively with patients and/or members of the public. However, current guidance on involving clinical trial participants in PPI activities is not consistent. METHODS: We reviewed the concept of participant involvement, based on our experience. Two workshops were held at the MRCCTU at UCL with the aim of defining participant involvement, considering its rationale; benefits and challenges; and identifying appropriate models for participant involvement in clinical trials. We considered how participant involvement might complement the involvement of other public contributors. Both workshops were attended by two patient representatives and seven staff members with experience of PPI in trials. Two of the staff members had also been involved in studies that had actively involved participants. They shared details of that work to inform discussions. RESULTS: We defined trial participants as individuals taking part in the study in question, including those who had already completed their trial treatment and/or follow-up. Because of their direct experience, involving participants may offer advantages over other public contributors; for example, in studies of new interventions or procedures, and where it is hard to identify or reach patient or community groups that include or speak for the study population. Participant involvement is possible at all stages of a trial; however, because there are no participants to involve during the design stage of a trial, prior to enrolment, participant involvement should complement and not replace involvement of PPI stakeholders. A range of models, including those with managerial, oversight or responsive roles are appropriate for involving participants; however, involvement in data safety and monitoring committees may not be appropriate where there is a potential risk of unblinding. Involvement of participants can improve the trial experience for other participants; optimising study procedures, improving communications; however, there are some specific, notably, managing participant confidentiality and practicalities relating to payments. CONCLUSIONS: Participant involvement in clinical trials is feasible and complements other forms of PPI in clinical trials. Involving active participants offers significant advantages, particularly in circumstances where trials are assessing new, or otherwise unavailable, therapies or processes. We recommend that current guidance on PPI should be updated to routinely consider including participants as valid stakeholders in PPI and potentially useful approach to PPI. date: 2018-02-07 date_type: published official_url: https://doi.org/10.1186/s13063-018-2471-4 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green article_type_text: Journal Article verified: verified_manual elements_id: 1534048 doi: 10.1186/s13063-018-2471-4 pii: 10.1186/s13063-018-2471-4 lyricists_name: Cragg, William lyricists_name: South, Annabelle lyricists_name: Sturgeon, Katherine lyricists_name: Vale, Claire lyricists_id: WCRAG85 lyricists_id: ASOUT21 lyricists_id: KSTUR26 lyricists_id: CVALE61 actors_name: Bracey, Alan actors_id: ABBRA90 actors_role: owner full_text_status: public publication: Trials volume: 19 article_number: 95 event_location: England issn: 1745-6215 citation: Vale, CL; Cragg, WJ; Cromarty, B; Hanley, B; South, A; Stephens, R; Sturgeon, K; Vale, CL; Cragg, WJ; Cromarty, B; Hanley, B; South, A; Stephens, R; Sturgeon, K; Gafos, M; - view fewer <#> (2018) When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL. Trials , 19 , Article 95. 10.1186/s13063-018-2471-4 <https://doi.org/10.1186/s13063-018-2471-4>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10043309/1/s13063-018-2471-4.pdf