FDA guidance on patient reported outcomes

BMJ (Online)

Volumn 341, Issue 7772, 2010, Pages 518-

  Speight, Jane ^a   Barendse, Shalleen M ^a  

^a BRUNEL UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; EDITORIAL; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; MEDICAL RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUESTIONNAIRE; RELIABILITY; TREATMENT OUTCOME; VALIDITY; HUMAN; OUTCOME ASSESSMENT; PATIENT SATISFACTION; STANDARD; UNITED STATES;

DRUG INDUSTRY; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SATISFACTION; PRACTICE GUIDELINES AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77954504186     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.c2921     Document Type: Editorial

References (9)

1. Department of Health. High quality care for all. NHS next stage review. 2008. www.dh.gov.uk/en/publicationsandstatistics/publications/ publicationspolicyandguidance/dh-085825.
2. Cole A. New outcome measures are to be introduced in four types of surgery. BMJ 2009;338:b648. [FREE Full text]
3. Black N, Jenkinson C. Measuring patients' experiences and outcomes. BMJ 2009;339:b2495. [FREE Full text]
4. Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of heath-related quality of life (HRQL) measures in the evaluation of medicinal products. 2005. www.emea.europa.eu/pdfs/human/ ewp/1393104en.pdf.
5. US Department of Health and Human Services Food and Drug Administration. Guidance for industry: patient report outcome measures: use in clinical medical product development to support labelling claims: draft guidance. Health Qual Life Outcomes 2006;4:79. [CrossRef] [Medline]
6. US Department of Health and Human Services Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009. www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
7. Stakeholder responses to the guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. www.fda.gov/ohrms/dockets/dockets/06d0044/06d0044.htm.
8. Timmins N. NHS goes to the PROMS. BMJ 2008;336:1464-5. [FREE Full text]
9. Caron M, Emery MP, Marquis P, Piault E, Scott J. Recent trends in the inclusion of patient-reported outcome (PRO) data in approved drugs labeling by the FDA and EMEA. PRO Newsletter2008;40.