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The opportunity for greater patient and public involvement and engagement in drug development and regulation

Patients and the wider public are beneficiaries of scientific research that leads to new drugs and medical technologies, but they can and should be able to contribute to these advances through participation in clinical studies, co-design of research and input into regulatory processes.
  1. Olalekan Lee Aiyegbusi

    1. Olalekan Lee Aiyegbusi1–5†, Samantha Cruz Rivera1,2, Kathy Oliver1,2,6, Elaine Manna1,2, Phil Collis1,2, Bellinda L King-Kallimanis7, Vishal Bhatnagar8, Ralf Herold9, Jon Hopkins10, Lisa Campbell10, Alysha Croker11, Myles Leach11 and Melanie J. Calvert1–5,12–141Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK; National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK; NIHR Birmingham-Oxford Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, UK; National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands, University of Birmingham, Birmingham, UK.

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  2. Samantha Cruz Rivera

    1. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK.

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  3. Kathy Oliver

    1. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK; International Brain Tumour Alliance (IBTA), Tadworth, UK.

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  4. Elaine Manna

    1. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK.

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  5. Phil Collis

    1. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK.

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  6. Bellinda L. King-Kallimanis

    1. LUNGevity Foundation, Bethesda, MD, USA.

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  7. Vishal Bhatnagar

    1. US Food and Drug Administration, Silver Spring, MD, USA.

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  8. Ralf Herold

    1. Task Force Regulatory Science and Innovation, European Medicines Agency, Amsterdam, The Netherlands.

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  9. Jon Hopkins

    1. Medicines and Healthcare Products Regulatory Agency, London, UK.

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  10. Lisa Campbell

    1. Medicines and Healthcare Products Regulatory Agency, London, UK.

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  11. Alysha Croker

    1. Centre for Policy, Pediatrics and International Collaboration, Health Canada, Ottawa, ON, Canada.

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  12. Myles Leach

    1. Centre for Policy, Pediatrics and International Collaboration, Health Canada, Ottawa, ON, Canada.

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  13. Melanie J. Calvert

    1. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK; National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK; NIHR Birmingham-Oxford Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, University of Birmingham, UK; National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands, University of Birmingham, Birmingham, UK; UK SPINE, University of Birmingham, Birmingham, UK; Health Data Research, Birmingham, UK; NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK.

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Nature Reviews Drug Discovery 22, 337-338 (2023)

doi: https://doi.org/10.1038/d41573-023-00031-x

Acknowledgements

O.L.A. receives funding from the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC), the NIHR Applied Research Collaboration (ARC), NIHR Birmingham-Oxford Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, at the University of Birmingham and University Hospitals Birmingham NHS Foundation, Innovate UK (part of UK Research and Innovation), Gilead Sciences, Merck and Sarcoma UK. S.C.R. receives funding from Merck, UK SPINE, and European Regional Development Fund – Demand Hub. M.J.C. receives funding from NIHR BRC, NIHR BTRU, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands, UK SPINE, European Regional Development Fund – Demand Hub, Health Data Research UK at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB Pharma, GSK, and Gilead Sciences. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies or organizations with which the authors are employed/affiliated.

References

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  4. Calvert, M. J. et al. Advancing UK regulatory science and innovation in healthcare. J. R. Soc. Med. 114, 5–11 (2021).

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Supplementary Information

  1. Supplementary information

Competing Interests

O.L.A. declares personal fees from Gilead Sciences, Merck and GSK outside the submitted work. S.C.R. declares personal fees from Merck. M.J.C. received personal fees from Astellas, Aparito, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK and the Patient-Centered Outcomes Research Institute outside the submitted work. In addition, a family member of M.J.C. owns shares in GSK. All other authors declare no competing interests.

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