Beyond the FDA PRO guidance: steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels.

TitleBeyond the FDA PRO guidance: steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels.
Publication TypeJournal Article
Year of Publication2012
AuthorsBasch E
JournalValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
Volume15
Issue3
Pagination401-3
Date Published2012 May
ISSN1524-4733
KeywordsClinical Trials as Topic; Drug Labeling; Guidelines as Topic; Humans; Outcome Assessment (Health Care); Patient Participation; Quality of Life; Self Report; United States; United States Food and Drug Administration
DOI10.1016/j.jval.2012.03.1385
Alternate JournalValue Health