2019
DOI: 10.1093/ecco-jcc/jjy222.589
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P465 UC trial designed more than 5 years ago in the light of the EMA guideline on the development of new medicinal products for the treatment of ulcerative colitis

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“…Therefore, the pediatric IBD care team must not only focus on medical treatment but also embrace the effect of the patient's everyday challenges and difficulties, and ultimately target the HRQoL. HRQoL has become an important patient-reported outcome and a recommended secondary outcome of clinical trials according to guidelines from the European Medicines Agency and US Food and Drug Administration (6)(7)(8)(9).…”
Section: What Is Newmentioning
confidence: 99%
“…Therefore, the pediatric IBD care team must not only focus on medical treatment but also embrace the effect of the patient's everyday challenges and difficulties, and ultimately target the HRQoL. HRQoL has become an important patient-reported outcome and a recommended secondary outcome of clinical trials according to guidelines from the European Medicines Agency and US Food and Drug Administration (6)(7)(8)(9).…”
Section: What Is Newmentioning
confidence: 99%