Patient reported outcome measures in the FDA pilot compendium: meeting today’s standards for patient engagement in development?

Value in Health

7 August 2018 - In 2016, the FDA released a pilot clinical outcome assessment compendium intended to foster patient-focused drug development. 

However, it is unclear whether patient perspectives were solicited during development or validation of the included patient-reported outcome measures.

PROs included in chapters 1 or 2 of the compendium were extracted and three reviewers independently searched PubMed and Google to identify information on measure pedigree. Data on method and stage of measure development where patient engagement took place were documented.

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Michael Wonder

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Michael Wonder