Patient-Reported Outcome Assessments in Gastrointestinal Clinical Trials: A Framework for Development and Validation

Am J Gastroenterol. 2022 Jul 1;117(7):1019-1021. doi: 10.14309/ajg.0000000000001739. Epub 2022 Mar 23.

Authors

Christopher O St Clair¹, Sarrit M Kovacs^{1

2}, Erica M Lyons^{1

2}, Jessica J Lee^{1

2}

Affiliations

¹ Division of Clinical Outcome Assessment, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, White Oak, Maryland, USA.
² Division of Gastroenterology, OND, CDER, FDA, White Oak, Maryland, USA.

PMID: 35333782
DOI: 10.14309/ajg.0000000000001739

No abstract available

MeSH terms

Clinical Trials as Topic
Gastrointestinal Diseases
Humans
Patient Outcome Assessment*
Patient Reported Outcome Measures*