Prime Time Was Yesterday for Patient-reported Outcomes in Daily Care of Patients With Inflammatory Bowel Diseases

With great interest we read the viewpoint of Cohen et al1 on the practical issues and hurdles for the use of patient reported outcomes (PROs) in clinical trials and daily inflammatory bowel disease (IBD) practice. The Food and Drug Administration and the European Medicine Association have indeed challenged the IBD community by raising the bar for endpoints in IBD clinical trials by requesting incorporation of PROs as primary endpoint. More time is needed to develop well-validated "real" PROs, because the economic impact of the implementation in clinical trials might be tremendous, both for the pharmaceutical industry and for the health care system.

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