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
“…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).…”
The IMPACT score, already known to correlate with disease activity, has now been shown to be associated with disease markers in feces and blood. This emphasizes that objective markers of disease activity indirectly can predict the patient's HRQoL.
“…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).…”
The IMPACT score, already known to correlate with disease activity, has now been shown to be associated with disease markers in feces and blood. This emphasizes that objective markers of disease activity indirectly can predict the patient's HRQoL.
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