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

Value in Health

Volumn 15, Issue 3, 2012, Pages 401-403

  Basch, Ethan ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); DRUG LABELING; FOOD AND DRUG ADMINISTRATION; HUMAN; OUTCOME ASSESSMENT; PATIENT CARE; PATIENT REFERRAL; PATIENT REPORTED OUTCOME; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; UNITED STATES;

EID: 84861149601     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2012.03.1385     Document Type: Editorial

References (5)

1. C. DeMuro, M. Clark, M. Mordin A review of patient-reported outcomes labels in the US: 2006-2010 Value Health 15 2013 437 442
2. U.S. Department of Health and Human Services, Food and Drug Administration Guidance for industry: patient-reported outcomes measures: use in medical product development to support labeling claims Issued December 2009 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM19328.pdf [Accessed March 24, 2010]
3. D. Wild, S. Eremenco, I. Mear Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report Value Health 12 2009 430 440
4. D.L. Patrick, L.B. Burke, C.J. Gwaltney Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2-assessing respondent understanding Value Health 14 2011 978 988
5. E. Basch The missing voice of patients in drug-safety reporting N Engl J Med 362 2010 865 869