Better engagement, better evidence: working in partnership with patients, the public, and communities in clinical trials with involvement and good participatory practice
Open accessAbstract
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.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Achieving meaningful involvement in inequalities-focused research requires the active inclusion of people from populations most affected.
“Achieving meaningful involvement in inequalities-focused research requires the active inclusion of people from populations most affected [24].”
From Layering perspectives: a structured approach to meaningful patient and public involvement and engagement in the RETURN dental trial (2026) · cites this paper as [24]
Cites
2 retracted
RETRACTED: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19
Mehra, M. R., Desai, S. S., Kuy, S., Henry, T. D., & Patel, A. N. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2007621 · Cited by 1,428 · see citing works
RetractedMehra, M. R., Ruschitzka, F., & Patel, A. N. (2020) · The Lancet · doi:10.1016/s0140-6736(20)31324-6 · Cited by 553 · see citing works
RetractedGreenhalgh, T., Hinton, L., Finlay, T., Macfarlane, A., Fahy, N., Clyde, B., & Chant, A. (2019) · Health Expectations · doi:10.1111/hex.12888 · Cited by 1,059 · see citing works
What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004) · The Journal of Infectious Diseases · doi:10.1086/381709 · Cited by 966 · see citing works
Crocker, J. C., Ricci‐Cabello, I., Parker, A., Hirst, J. A., Chant, A., Petit-Zeman, S., Evans, D., & Rees, S. (2018) · BMJ · doi:10.1136/bmj.k4738 · Cited by 627 · see citing works
How COVID-19 has fundamentally changed clinical research in global health
Park, J., Mogg, R., Smith, G. E., Nakimuli‐Mpungu, E., Jehan, F., Rayner, C. R., Condo, J. U., Decloedt, E. H., Nachega, J. B., Reis, G., et al. (2021) · The Lancet Global Health · doi:10.1016/s2214-109x(20)30542-8 · Cited by 220 · see citing works
Vat, L. E., Finlay, T., Jan Schuitmaker‐Warnaar, T., Fahy, N., Robinson, P., Boudes, M., Diaz, A., Ferrer, E., Hivert, V., Purman, G., et al. (2020) · Health Expectations · doi:10.1111/hex.12951 · Cited by 173 · see citing works
Impact of COVID-19 on oncology clinical trials
Upadhaya, S., Yu, J. X., Oliva, C., Hooton, M., Hodge, J. P., & Hubbard-Lucey, V. M. (2020) · Nature Reviews Drug Discovery · doi:10.1038/d41573-020-00093-1 · Cited by 139 · see citing works
The Abandoned Trials of Pre-Exposure Prophylaxis for HIV: What Went Wrong?
Singh, J. A., & Mills, E. J. (2005) · PLoS Medicine · doi:10.1371/journal.pmed.0020234 · Cited by 133 · see citing works
Enria, L., Lees, S. S., Smout, E. M., Mooney, T., Tengbeh, A. F., Leigh, B., Greenwood, B. M., Watson‐Jones, D., & Larson, H. J. (2016) · BMC Public Health · doi:10.1186/s12889-016-3799-x · Cited by 127 · see citing works
Building an evidence base for stakeholder engagement
Lavery, J. V. (2018) · Science · doi:10.1126/science.aat8429 · Cited by 123 · see citing works
Lauzon-Schnittka, J., Audette-Chapdelaine, S., Boutin, D., Wilhelmy, C., Auger, A.-M., & Brodeur, M. (2022) · Research Involvement and Engagement · doi:10.1186/s40900-022-00388-0 · Cited by 75 · see citing works
Dada, S., McKay, G., Mateus, A., & Lees, S. S. (2019) · BMC Public Health · doi:10.1186/s12889-019-7978-4 · Cited by 73 · see citing works
Lwin, K. M., Cheah, P. Y., Cheah, P. K., White, N. J., Day, N., Nosten, F. H., & Parker, M. J. (2014) · BMC Medical Ethics · doi:10.1186/1472-6939-15-12 · Cited by 67 · see citing works
Self-citationUsing scientific authorship criteria as a tool for equitable inclusion in global health research
Sam-Agudu, N. A., & Abímbọ́lá, Ṣ. (2021) · BMJ Global Health · doi:10.1136/bmjgh-2021-007632 · Cited by 48 · see citing works
Goossens, H., Derde, L. P. G., Horby, P., & Bonten, M. J. M. (2021) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(21)00705-2 · Cited by 48 · see citing works
The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study
Murphy, A. A., Bere, N., Vamvakas, S., et al. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2021.811855 · Cited by 43 · see citing works
Vanderslott, S., Ryneveld, M. V., Marchant, M., Lees, S. S., Nolna, S. K., & Marsh, V. (2021) · BMC Public Health · doi:10.1186/s12889-021-10348-0 · Cited by 42 · see citing works
Vincent, R., Adhikari, B., Duddy, C., Richardson, E. Z. L., Wong, G., Lavery, J. V., Molyneux, S. C., & The REAL team: Mary Chambers, P. Y. C. (2022) · Wellcome Open Research · doi:10.12688/wellcomeopenres.17192.1 · Cited by 41 · see citing works
Goossens, H., Derde, L., Horby, P., et al. (2022) · Utrecht University Repository (Utrecht University) · Cited by 38 · see citing works
Gobat, N., Butler, C. C., Mollison, J., Francis, N. A., Gal, M., Harris, V., Webb, S. A. R., Byrne, J.-P., Watkins, A., Sukumar, P., et al. (2019) · Public Health · doi:10.1016/j.puhe.2019.07.005 · Cited by 36 · see citing works
Self-citationPublic health measures for covid-19
Glasziou, P., Michie, S., & Fretheim, A. (2021) · BMJ · doi:10.1136/bmj.n2729 · Cited by 36 · see citing works
Schilling, I., & Gerhardus, A. (2024) · BMC Medical Research Methodology · doi:10.1186/s12874-024-02323-1 · Cited by 29 · see citing works
Salloum, M., Paviotti, A., Bastiaens, H., & Geertruyden, J. V. (2023) · Vaccine · doi:10.1016/j.vaccine.2023.10.057 · Cited by 28 · see citing works
Chan, E. Y. Y., Gobat, N., Dubois, C., et al. (2021) · The Lancet · doi:10.1016/s0140-6736(21)01233-2 · Cited by 27 · see citing works
Self-citationPolonsky, J. A., Bhatia, S., Fraser, K., Hamlet, A., Skarp, J. E., Stopard, I. J., Hugonnet, S., Kaiser, L., Lengeler, C., Blanchet, K., et al. (2022) · Infectious Diseases of Poverty · doi:10.1186/s40249-022-00935-7 · Cited by 25 · see citing works
Jamal, Z., Perkins, A., Allen, C., Research Advisory Group, Evans, R., Sturgess, J., Snowdon, C., Clayton, T. C., & Elbourne, D. R. (2021) · Research Involvement and Engagement · doi:10.1186/s40900-021-00250-9 · Cited by 23 · see citing works
Compassionate drug (mis)use during pandemics: lessons for COVID-19 from 2009
Rojek, A. M., Martin, G. E., & Horby, P. (2020) · BMC Medicine · doi:10.1186/s12916-020-01732-5 · Cited by 19 · see citing works
Beyond recruitment: good participatory practice enhances the impact of research in a pandemic
Wilson, B., Wright, K., Taylor, R. J., et al. (2021) · Nature Medicine · doi:10.1038/s41591-021-01271-3 · Cited by 18 · see citing works
Lee, T. C., Senécal, J., Hsu, J. M.-Y., & McDonald, E. G. (2021) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2021.4112 · Cited by 16 · see citing works
Wilkinson, A., Slack, C. M., Thabethe, S., et al. (2022) · Journal of Empirical Research on Human Research Ethics · doi:10.1177/15562646221078415 · Cited by 15 · see citing works
Self-citationClinical trials and their impact on policy during COVID-19: a review
Glasziou, P., Sanders, S., Byambasuren, O., et al. (2024) · Wellcome Open Research · doi:10.12688/wellcomeopenres.19305.1 · Cited by 13 · see citing works
Davies, A., Ormel, I., Bernier, A., Harriss, E., Mumba, N., Gobat, N., Schwartz, L. J., & Cheah, P. Y. (2023) · Wellcome Open Research · doi:10.12688/wellcomeopenres.19318.1 · Cited by 12 · see citing works
Self-citationDisparities in COVID-19 clinical studies from high-income and low-and middle-income countries
Sha, Y., Ren, J., Jie, X., Li, P., Luo, J., Yin, J., Luo, L., Li, Z., & Luo, G. (2023) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2023.04.393 · Cited by 11 · see citing works
Double Standards in Medical Research in Developing Countries
Schüklenk, U. (2004) · BMJ · doi:10.1136/bmj.329.7475.1190 · Cited by 5 · see citing works
Wilkinson, A., Slack, C. M., Crews, C., et al. (2021) · South African Journal of Bioethics and Law · doi:10.7196/sajbl.2021.v14i1.00698 · Cited by 4 · see citing works
Self-citationWright, K., Ali, J., Davies, A., et al. (2023) · BMJ Global Health · doi:10.1136/bmjgh-2023-012930 · Cited by 3 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Lowers, V., Stanley, M., Hennessy, J., Morgan, E., Horsley, R., Vithlani, J., & Harris, R. V. (2026) · Research involvement and engagement · doi:10.1186/s40900-026-00857-w
“Achieving meaningful involvement in inequalities-focused research requires the active inclusion of people from populations most affected [24].”
- Authors
- 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.
- Affiliations
- World Health Organization (CH)
- South African Medical Research Council (ZA)
- Wellcome Trust (GB)
- Health Research Authority (GB)
- Mahidol University (TH)
- PENTA Foundation (IT)
- KEMRI-Wellcome Trust Research Programme (KE)
- University of Oxford (GB)
- Makerere University Walter Reed Project (UG)
- McMaster University (CA)
- Council for International Organizations of Medical Sciences (CH)
- Corresponding author
- Gobat, Nina
- ORCID
- Venue
- The Lancet Global Health
- Publisher
- Elsevier BV
- Published
- 2025-04
- Volume
- 13
- Issue
- 4
- Pages
- e716-e731
- ISSN
- 2214-109X (ISSN-L)
- OpenAlex
- W4408936368
- Cited by
- 61
- References
- 37
- Citations by year
- 2026: 48 · 2025: 12 · 2024: 1
- FWCI
- 11.44
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- The Lancet Global Health (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Wellcome Trust
- European and Developing Countries Clinical Trials Partnership (CSA2023WHO-3454-WHORCT)
- World Health Organization
- Bill & Melinda Gates Foundation
- South African Medical Research Council
- National Institute for Health and Care Research
- European Commission
- UK Government Foreign Commonwealth & Development Office (222037/A/20/Z.)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Health Sciences › Health Professions › General Health Professions › Community Health and Development
- Keywords
- patient and public involvement, community participation, participatory research, clinical trials, research trust, research ethics, trial design, research funding, regulatory oversight, public health emergencies, structural inequality
- MeSH terms
- Stakeholder Participation, Clinical Trials as Topic, Community Participation, Humans, Patient Participation, World Health Organization
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
