Patient involvement is being encouraged throughout the development lifecycle of new medicines and devices. Many stakeholders (eg, patients, carers, regulators, payers, drug and device companies) have welcomed patient involvement as an important and fundamental change in the development lifecycle, and have promoted the potential benefits that meaningful, transparent, and ethical interactions with patients could bring. As with any change, however, research should be conducted to ensure the potential benefits and harms of patient involvement are understood, and that evidence-based best practices can be identified.
Compared with research on patient involvement in the clinical trial process, there appears to have been relatively limited research on patient involvement in the peer-reviewed publication process. Publications can affect patient care and we have shown that patients are engaging with the peer-reviewed literature. Consistent with this interest from patients, medical journals are striving to facilitate greater patient involvement in the peer-reviewed publication ecosystem (eg, as authors, peer-reviewers, readers). The extent of published evidence on patient involvement in peer-reviewed publications, however, is not known.
In addition to sharing clinical trial results through the peer-reviewed publications, results can also be shared through clinical trial results summaries. The forthcoming regulatory requirement in Europe to provide plain-language clinical trial results summaries has driven strong interest in this method of results sharing. The extent of published evidence on patient involvement in clinical trial results summaries, however, is not known.
The systematic literature review is directed toward audiences who want to know the size and quality of the evidence base that exists to guide patient involvement in peer-reviewed publications and clinical trial results summaries.
Identifying the size and quality of the evidence base to guide best practices for Patient involvement in sharing clinical trial results
Problems addressed by Initiative
Patient involvement in sharing clinical trial results
Quality of patient engagement
To conduct the first systematic literature review on patient involvement in preparing clinical research peer-reviewed publications or results summaries.
How have you confirmed with all stakeholders that your purpose is understood, that
contributions have influenced the original plans and that disagreements have been
All stakeholders had to sign the Authorship Agreement (see attached), which was written in plain language to enhance understanding by all authors – patient authors and non-patient authors. By signing the Agreement, stakeholders had to confirm they understood the purpose of the project, the expected contributions they would need to make, and what rules would need to be followed to ensure the quality of the project would lead to a successful outcome.
Opportunities to influence the original plan were provided during development of the protocol, at authorship meetings, and during the development of presentations and the publication of the results.
Have you reviewed the shared purpose and its understanding among stakeholders?
Yes, at multiple time points.
At which time points?
Before the project started (e.g. during the author candidate calls and author kick-off meeting).
During the project (e.g. at authorship calls).
After the project (e.g. the Patient Authorship Experience Tool – attached); this tool will be completed by all authors at the end of the project. We developed this tool based on the PFMD Patient Engagement Quality Guidance Tool and incorporated patient and non-patient author feedback as part of a co-creation process.
To ensure continuity of the project and relationships from the beginning to the end, a publication plan was developed. This plan identified key milestones for presenting and publishing our research and these ‘external communication points’ helped build a sense of teamwork and a focus on delivering high-quality output.
To help share the learnings from this project, we have committed to presenting and publishing our research.
We have included a specific section in the publication of this project of ‘lessons learned’ that we hope will help other researchers as they conduct further studies on patient involvement in publications.
We are also consulting with our patient authors as to their interest in presenting at conferences, after this project concludes, to help inspire (if not challenge) research funders and researchers to involve patients as authors.
In terms of sustainability, we are also striving to provide practical support and training to help more patients become authors (eg, working with EUPATI to prepare a publications module for their curriculum; providing publication training for patient advocates at medical conferences).
Results and outcomes
Professor Karen Woolley
Global Lead, Patient Partnerships, Envision Pharma Group