Abstract
Clinical trials to evaluate the safety and efficacy of new therapeutics are notably time- and resource-intensive. This is especially true in pediatric trials, where both subjects (children) and their caretakers (parents) are often subject to history-, physical exam- and laboratory-based assays. Efforts to develop complementary metrics in these types of evaluation, however, have grown, with collaboration among federal and industry partners. In this volume of The Journal, Miller et al report on their experiences using the Patient-Reported Outcomes Measurement Information System (PROMIS) in the setting of a randomized trial of new therapies for inflammatory bowel disease.
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