Better engagement, better evidence: working in partnership with patients, the public, and communities in clinical trials with involvement and good participatory practice
Issued Date
2025-04-01
Resource Type
ISSN
2572116X
eISSN
2214109X
Scopus ID
2-s2.0-105000992719
Journal Title
The Lancet Global Health
Volume
13
Issue
4
Start Page
e716
End Page
e731
Rights Holder(s)
SCOPUS
Bibliographic Citation
The Lancet Global Health Vol.13 No.4 (2025) , e716-e731
Suggested Citation
Gobat N., Slack C., Hannah S., Salzwedel J., Bladon G., Burgos J.G., Purvis B., Molony-Oates B., Siegfried N., Cheah P.Y., Conway M., Kamuya D., Davies A., Johnson T., Tholanah M., Mugamba S., Mutengu N.L., Machingaidze S., Schwartz L., Rägo L., von Harbou K. Better engagement, better evidence: working in partnership with patients, the public, and communities in clinical trials with involvement and good participatory practice. The Lancet Global Health Vol.13 No.4 (2025) , e716-e731. e731. doi:10.1016/S2214-109X(24)00521-7 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/109330
Title
Better engagement, better evidence: working in partnership with patients, the public, and communities in clinical trials with involvement and good participatory practice
Author's Affiliation
Makerere University Walter Reed Project
Mahidol Oxford Tropical Medicine Research Unit
Penta Foundation
European Medicines Agency
McMaster University
South African Medical Research Council
Organisation Mondiale de la Santé
Nuffield Department of Medicine
International Pandemic Preparedness Secretariat
Health Research Authority
Harare Health and Research Consortium
The African Alliance
Wellcome
Council for International Organizations of Medical Sciences (CIOMS)
Science for Africa Foundation (SFA)
AVAC
KEMRI-Wellcome Trust Collaborative Research Programme
Mahidol Oxford Tropical Medicine Research Unit
Penta Foundation
European Medicines Agency
McMaster University
South African Medical Research Council
Organisation Mondiale de la Santé
Nuffield Department of Medicine
International Pandemic Preparedness Secretariat
Health Research Authority
Harare Health and Research Consortium
The African Alliance
Wellcome
Council for International Organizations of Medical Sciences (CIOMS)
Science for Africa Foundation (SFA)
AVAC
KEMRI-Wellcome Trust Collaborative Research Programme
Corresponding Author(s)
Other Contributor(s)
Abstract
In May 2022, member states of WHO adopted the World Health Assembly WHA75.8 resolution on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. The resolution recognises the central role of community stakeholders in the clinical trial ecosystem. This paper aims to take stock of the state of the field and define key actions from stakeholders across the clinical trial ecosystem for systematic engagement of patient, public, and community stakeholders in clinical trials. Upfront, sustained, inclusive, and meaningful engagement with patients, public, and community stakeholders intended to benefit from trial outcomes is crucial for several reasons. First, better engagement ensures that trials are well designed and well implemented by considering the unique perspectives and experiences of those they aim to benefit. Second, better engagement enhances the scientific, ethical, and pragmatic value of trials by improving the acceptability, feasibility, and relevance of trial design, implementation, and outcome dissemination. Lastly, improving engagement fosters trust in science and scientists, strengthens research literacy, and contributes to greater trust in research processes. This trust is particularly important in public health emergencies where the urgency for identifying effective interventions, including new vaccines and medicines, often results in limited engagement. In practice, engagement involves activities throughout the trial lifecycle, including research agenda setting, protocol development, trial conduct, and outcome dissemination. Key stakeholders, such as researchers, funders, research ethics committees, and regulators play crucial roles in enabling and implementing engagement via participatory practices. Despite some key markers of progress, challenges remain, including systemic gaps, limited engagement beyond tokenistic involvement, and structural inequities. Addressing these challenges requires action across the clinical trial ecosystem, including strengthening policies, enhancing funding mechanisms, improving regulatory oversight, advocacy, and education of all stakeholders about engagement, and promoting a strong culture of engagement. Advancing the agenda for engagement can promote trust, ethical research conduct, and improve outcomes and wider uptake of findings.