Treatment optimisation in drug development
The current drug development paradigm is too 'drug-centred' and does not sufficiently take the patients that will receive the new therapy into account. This has led to the emergence of a research gap between the pre-approval development of medicines and their post-approval use in real-world conditions. This gap could potentially be bridged by transitioning towards a patient-focused framework that places strong emphasis on treatment optimisation, which strives to optimise the way health treatments are applied in clinical practice. Questions remain however regarding the ideal features of treatment optimisation studies and their acceptability among key stakeholders. In this qualitative research study, semi-structured interviews were performed with 26 experts across 5 stakeholder groups and 10 different EU Member States. The results offer an overview of the concept of treatment optimisation. A set of policy options is also presented that could help enable implementation of treatment optimisation.
Short title:
Treatment optimisation in drug development
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Project leader:
European Parliament / Panel for the Future of Science and Technology (STOA) (STOA)