Public Involvement in the Design and Conduct of Clinical Trials: A Review

By Jonathan Boote, Wendy Baird and Anthea Sutton.

Published by The Social Sciences Collection

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Article: Print $US10.00
Article: Electronic $US5.00

Background: Public involvement is health research policy in the UK and internationally. There is a need to establish a robust evidence base on the impact of public involvement on research processes and outcomes.
Purpose: To review examples of public involvement in the design and conduct of clinical trials, to synthesise the contributions of the public, as well as the identified tensions and facilitating strategies.
Method: Systematic literature search and narrative review.
Results: Nine papers were identified, covering the following topics: breast-feeding, antiretroviral and nutrition interventions; paediatric resuscitation; exercise and cognitive behavioural therapy; breast cancer; stroke; chronic suppurative otitis media; Paget's disease; and shared decision-making in patient consultations. Six papers reported on public involvement at the trial design stage, while three reported on public involvement at the design and conduct stages of clinical trials. It was found that the public contributed at the consultation, collaboration and publicly-led levels of involvement. Four main public contributions to trial design were identified: review of consent procedures and patient information sheets; suggestion of additional trial outcomes; review of trial data collection procedures; and recommendations on the timing and location of follow-up data collection. Two main contributions that the public made to the conduct of trials were identified: scrutiny of the conduct of the trial through membership of the Trial Steering Committee; and delivering the trial protocol after completing relevant training. Numerous tensions and facilitating strategies were identified.
Limitations: Papers on public involvement in the design and conduct of clinical trials may have been overlooked due to the difficulty of searching for, and identifying, papers in this area. Only English publications were searched for and the review focused on evidence in peer-reviewed journal articles only.
Conclusions: The issues raised here should assist researchers in developing and conducting clinical trials with the involvement of the public.

Keywords: Public Involvement, Clinical Trials, Design, Conduct, Narrative Literature Review

International Journal of Interdisciplinary Social Sciences, Volume 5, Issue 11, pp.91-112. Article: Print (Spiral Bound). Article: Electronic (PDF File; 1.057MB).

Dr. Jonathan Boote

Research Fellow, NIHR Research Design Service for Yorkshire and the Humber, NIHR Research Design Service for Yorkshire and the Humber, Sheffield, South Yorkshire, UK

Dr. Jonathan Boote is employed by the NIHR Research Design Service for Yorkshire and the Humber as a Research Fellow with particular responsibility for patient and public involvement, and has been involved in a programme of research on patient and public involvement in health research at the University of Sheffield for the last 10 years. He has published in numerous journals including Health Policy, Health Expectations, Journal of Advanced Nursing, Clinical Governance: an International Journal, Clinical Effectiveness in Nursing, and Research Ethics Review. Before joining the Research Design Service, Jonathan was employed in the NHS, working as a Senior Research Officer for Sheffield Health and Social Care NHS Foundation Trust, and as a Research Manager for Sheffield Health and Social Research Consortium. Jonathan is a member of the NIHR Stroke Research Network’s Clinical Studies Group on Patient, Carer and Public Involvement, the Strategic Local Priority Group for Patient and Public Involvement in South Yorkshire, and invoNET.

Dr. Wendy Baird

Director, NIHR Research Design Service for Yorkshire and the Humber, NIHR Research Design Service for Yorkshire and the Humber, Sheffield, South Yorkshire, UK

Dr. Wendy Baird is the Director of the NIHR Research Design Service for Yorkshire and the Humber. Her research has largely been related to the assessment of health care needs in people with a disability with particular emphasis on oral health, multiple sclerosis and older people in rural areas. Most recently, her research portfolio has been in the field of multiple sclerosis around the establishment of a population-based register of people with MS in the UK.

Anthea Sutton

Information Specialist (Reviews and Special Projects), Health Economics and Decision Science, University of Sheffield, Sheffield, South Yorkshire, UK

Anthea Sutton is an Information Specialist (Reviews and Special Projects) in the School of Health and Related Research, University of Sheffield. Her research interests include e-learning, systematic literature searching and the provision of information for health management. Anthea has published in a range of journals including Health Information and Libraries Journal, Impact: Journal of Applied Research in Workplace E-learning and The Journal of Continuing Education in the Health Professions.

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