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Can a multi-stakeholder prioritisation structure support regulatory decision making? A review of paediatric oncology strategy forums reflecting on challenges and opportunities of this concept.

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Timely and successful drug development for rare cancer populations, such as paediatric oncology requires consolidated efforts in the spirit of shared responsibility. In order to advance tailored development efforts, the… Click to show full abstract

Timely and successful drug development for rare cancer populations, such as paediatric oncology requires consolidated efforts in the spirit of shared responsibility. In order to advance tailored development efforts, the concept of multi-stakeholder Strategy Forum involving industry, academia, patient organisations and regulators has been developed. We review the first five paediatric oncology Strategy Forums co-organised by the European Medicines Agency between 2017 and 2020, reflecting on the outcomes and the evolution of the concept over time and providing an outline of how a 'safe space' for multi-stakeholder engagement facilitated by regulators could be of potential value beyond paediatric oncology drug development.

Keywords: strategy forums; oncology strategy; multi stakeholder; paediatric oncology; oncology

Journal Title: Clinical pharmacology and therapeutics
Year Published: 2020

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