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A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary

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Abstract

The Copenhagen Centre for Regulatory Science (CORS) and Biopeople at the University of Copenhagen held a workshop in May 2015 titled “Patient Involvement in Medicines Development and Approvals: A Paradigm Shift Towards True Patient Impact in Medicines Development and Regulatory Science” that acknowledged the importance of having patients more involved in the entire process of medicines research and development (R&D) and life cycle management. Four key stakeholders, representing patients, academia, industry, and regulatory authorities, each gave their view and perspective on the status and challenges of current patient involvement. From the 3 breakout sessions, it was concluded that patient-reported outcomes (ie, the report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else), was considered as an important tool when deciding endpoints. It was agreed that professionalization of the patient within medicine R&D to some extent would be necessary for obtaining influence. However, the industry should also seek to accommodate to the patient instead of waiting passively for patients to become educated. A much better organized and stronger involvement of patients was called for. However, this should not only rely on goodwill, but should preferably be implemented by legal requirements, so as to secure compliance by all stakeholders. An independent platform with the purpose of providing access to patient experience was proposed. A research and educational center such as CORS, which was founded on cross-sectorial and cross-disciplinary cooperation, is an example of an institution that could be a good starting point for hosting such a platform.

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Authors and Affiliations

  1. Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark

    Gitte Borup MSc, Pharm, Karin Friis Bach MSc, Pharm, Helle Wallach-Kildemoes PhD, Ole Jannik Bjerrum DMSc, MD & Niels Westergaard PhD, DSc, Pharm

  2. Copenhagen Centre for Regulatory Sciences, Copenhagen, Denmark

    Gitte Borup MSc, Pharm & Karin Friis Bach MSc, Pharm

  3. Biopeople, Denmark’s Life Science Cluster, University of Copenhagen, Copenhagen, Denmark

    Niels Westergaard PhD, DSc, Pharm

  4. Novo Nordisk A/S, Bagsvaerd, Denmark

    Merete Schmiegelow MSc, Pharm

  5. Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark

    Helle Wallach-Kildemoes PhD

  6. Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark

    Ole Jannik Bjerrum DMSc, MD

Authors
  1. Gitte Borup MSc, Pharm
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  2. Karin Friis Bach MSc, Pharm
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  3. Merete Schmiegelow MSc, Pharm
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  4. Helle Wallach-Kildemoes PhD
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  5. Ole Jannik Bjerrum DMSc, MD
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  6. Niels Westergaard PhD, DSc, Pharm
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Corresponding author

Correspondence to Gitte Borup MSc, Pharm.

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Borup, G., Bach, K.F., Schmiegelow, M. et al. A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary. Ther Innov Regul Sci 50, 304–311 (2016). https://doi.org/10.1177/2168479015622668

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  • DOI: https://doi.org/10.1177/2168479015622668

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