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Review
. 2023 Aug 23;13(8):e071339.
doi: 10.1136/bmjopen-2022-071339.

Characterising meaningful patient and public involvement in the pharmaceutical industry research setting: a retrospective quality assessment

Sally-Anne Dews  1 , Adit Bassi  2 , Sean Buckland  3 , Lucy Clements  3 , Rachel Daley  4 , Angela Davies  5 , Sophie Evett  3 , Samantha Howland  3 , Emma Kinloch  6 , Berkeley Phillips  3 , Gareth Powell  7 , Jennifer Preston  8 , Kamil Sterniczuk  9 , Natalie Bohm  3   10
Affiliations
Review

Characterising meaningful patient and public involvement in the pharmaceutical industry research setting: a retrospective quality assessment

Sally-Anne Dews et al. BMJ Open. .

Abstract

Objectives: Patient and public involvement (PPI) in clinical research has a well-established infrastructure in the UK, and while there has been good progress within pharmaceutical-industry-sponsored research, further improvements are still needed. This review aims to share learnings from quality assessments of historical PPI projects within Pfizer UK to inform future projects and drive PPI progress in the pharmaceutical industry.

Design and setting: Internal assessments of Pfizer UK PPI projects were conducted to identify all relevant projects across the medicines development continuum between 2017 and 2021. Five sample projects were developed into case studies.

Outcome measure: Retrospective quality assessments were performed using the Patient Focused Medicines Development (PFMD) Patient Engagement Quality Guidance (PEQG) tool. Recommendations for improvement were developed.

Results: Retrospective case study analysis and quality framework assessment revealed benefits of PPI to both Pfizer UK and to external partners, as well as challenges and learnings to improve future practice. Recommendations for improvement based on these findings focused on processes and procedures for PPI, group dynamics and diversity for PPI activities, sharing of expertise, the importance of bidirectional and timely feedback, and the use of understandable language in materials.

Conclusions: PPI in medicines development is impactful and beneficial but is still being optimised in the pharmaceutical industry. Using the PFMD PEQG tool to define gaps, share learnings and devise recommendations for improvement helps to ensure that PPI is genuine and empowering, rather than tokenistic. Ultimately, these recommendations should be acted on to further embed PPI as an integral part of medicines development and health research within the pharmaceutical industry. This article includes a plain language summary in the supplement.

Keywords: MEDICAL EDUCATION & TRAINING; QUALITATIVE RESEARCH; Quality in health care.

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Conflict of interest statement

Competing interests: S-AD, SB, LC, SE, SH, BP and NB are employees of Pfizer and hold Pfizer stock. AB, RD, AD, EK, GP, JP and KS have no competing interests to report.

Figures

Figure 1
Figure 1
Types of possible PPI activities, the benefits of incorporating them and the Pfizer UK PPI projects identified across the medicines development continuum. HTA, health technology assessment; NHS, National Health Service; PPI, patient and public involvement; RWE, real-world evidence.
See this image and copyright information in PMC

References

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    1. National Institute for Health and Care Research . Briefing notes for researchers - public involvement in NHC, health and social care research. Available: https://www.nihr.ac.uk/documents/briefing-notes-for-researchers-public-i... [Accessed 29 Jul 2022].
    1. NIHR Involve . What is public involvement in research? Available: https://www.invo.org.uk/find-out-more/what-is-public-involvement-in-rese... [Accessed 29 Jul 2022].
    1. National Co-ordinating Centre for Public Engagement . What is public engagement? Available: https://www.publicengagement.ac.uk/about-engagement/what-public-engagement [Accessed 29 Jul 2022].
    1. Department of Health SSaPS . Personal and public involvement consultation scheme. Available: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/DHS... [Accessed 1 Aug 2022].

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