Marie-Pierre Emery

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The exponential development of Patient-Reported Outcomes (PRO) measures in clinical research has led to the creation of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID) to facilitate the selection process of PRO measures in clinical research. The project was initiated by Mapi Research Trust in Lyon, France. Initially called(More)
Objective: The objective of this research was to review the extent to which health-related quality of life (HR-QOL) and other patient-reported outcomes (PROs) have played a role in drug approval and labelling since 2006, when the US FDA issued its draft guidance on the use of PRO measures and the European Medicines Agency (EMA), its reflection paper on(More)
The Berne Convention and the national laws on intellectual property fully apply to PRO instruments. The identification of and access to an original PRO instrument is often associated with copyright ownership. This is the copyright holder of the instrument who will control its access (distribution and reproduction), its adaptation or modification, and its(More)
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