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Co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative
  1. Katherine Deane1,
  2. Laure Delbecque2,
  3. Oleksandr Gorbenko3,
  4. Anne Marie Hamoir4,
  5. Anton Hoos4,
  6. Begonya Nafria5,
  7. Chi Pakarinen4,
  8. Ify Sargeant4,
  9. Dawn P Richards6,
  10. Soren Eik Skovlund7,
  11. Nicholas Brooke4
  12. on behalf of the PFMD Patient Engagement Meta-framework Co-creation Team
    1. 1 School of Health Sciences, University of East Anglia, Norwich, UK
    2. 2 Patient Reported Outcomes, Pharmerit International, Rotterdam, Belgium
    3. 3 Chief Scientific and Medical Office – Patient Affairs, ViiV Healthcare, London, UK
    4. 4 Patient Focused Medicines Development, Brussels, Belgium
    5. 5 Patient Engagement in Research, Institut de Recerca Sant Joan de Déu- Hospital Sant Joan de Déu, Esplugues de Llobregat, Spain
    6. 6 Clinical Trials Ontario, Toronto, Ontario, Canada
    7. 7 Steno Diabetes Centre North Denmark, Aalborg University Hospital, Aalborg, Denmark
    1. Correspondence to Anne Marie Hamoir, Patient Focused Medicines Development, Brussels 1050, Belgium; am.hamoir{at}thesynergist.org

    Footnotes

    • Contributors AMH, CP and NB identified participants, planned and organised multistakeholder working group workshops to co-create the PE Quality Guidance. KHOD, LD, OG, AMH, BNE, CP, DP, SES and NB participated in PE Quality Guidance co-creation workshops, tested and reviewed iterative drafts of the PE Quality Guidance; KHOD, SES, OG DR, LD, BNE, AMH, CP were part of the Core Team that reviewed and evaluated the example cases/projects for the Book of Good Practices; KHOD, LD, OG, AMH, BNE, CP, IS, DP, SES, NB jointly (and as part of a larger contributor group) reviewed the final versions of the PE Quality Guidance, scenarios and Book of Good Practices before release; KHOD, LD, OG, AMH, AH, BNE, CP, IS, DP, SES, NB jointly planned the manuscript and agreed the outline (with each author having responsibility for writing a specific section of the paper); IS coordinated writing efforts and developed each draft by collating and editing sections written by authors; circulated drafts for author review; collated and implemented author comments at each draft stage. KHOD, LD, OG, AMH, AH, BNE, CP, IS, DP, SES, NB reviewed and approved the final manuscript for submission.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests DR: personal fees from various pharmaceutical companies, outside the submitted work; NB: grants from various pharmaceutical companies and personal fees from Innovative Medicine Initiative outside the submitted work.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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    Footnotes

    • Contributors AMH, CP and NB identified participants, planned and organised multistakeholder working group workshops to co-create the PE Quality Guidance. KHOD, LD, OG, AMH, BNE, CP, DP, SES and NB participated in PE Quality Guidance co-creation workshops, tested and reviewed iterative drafts of the PE Quality Guidance; KHOD, SES, OG DR, LD, BNE, AMH, CP were part of the Core Team that reviewed and evaluated the example cases/projects for the Book of Good Practices; KHOD, LD, OG, AMH, BNE, CP, IS, DP, SES, NB jointly (and as part of a larger contributor group) reviewed the final versions of the PE Quality Guidance, scenarios and Book of Good Practices before release; KHOD, LD, OG, AMH, AH, BNE, CP, IS, DP, SES, NB jointly planned the manuscript and agreed the outline (with each author having responsibility for writing a specific section of the paper); IS coordinated writing efforts and developed each draft by collating and editing sections written by authors; circulated drafts for author review; collated and implemented author comments at each draft stage. KHOD, LD, OG, AMH, AH, BNE, CP, IS, DP, SES, NB reviewed and approved the final manuscript for submission.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests DR: personal fees from various pharmaceutical companies, outside the submitted work; NB: grants from various pharmaceutical companies and personal fees from Innovative Medicine Initiative outside the submitted work.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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