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There is growing acknowledgement among international stakeholders, including regulators, health technology assessment (HTA) bodies and professional societies, that the inclusion of patient‐reported outcome measures (PROMs) in clinical trials should be guided by clear rationales. In this regard, existing PROMs may overreach or fall short in measuring domains most relevant for a specific study's context, population, treatments and stakeholders.

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Authors: Carrie‐Anne Ng, Jessica Roydhouse, Tim Luckett, Richard De Abreu Lourenco and Brendan Mulhern

Article Type: Perspective