Health-related quality of life (HR-QOL) and regulatory issues: An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval

PharmacoEconomics

Volumn 19, Issue 2, 2001, Pages 187-195

  Apolone, Giovanni ^a   De Carli, Gianfranco ^b   Brunetti, Massimo ^c   Garattini, Silvio ^a  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^b GLAXOSMITHKLINE   (United States)

^c Centro Valutazione Efficacia Assistenza Sanitaria   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHYPERTENSIVE AGENT; ANTINEOPLASTIC AGENT; ANTIVIRUS AGENT;

ALZHEIMER DISEASE; ANGINA PECTORIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL; DATA ANALYSIS; DRUG APPROVAL; EVALUATION; FOOD AND DRUG ADMINISTRATION; HEALTH CARE; HEALTH ECONOMICS; HEALTH STATUS; HEART FAILURE; HUMAN; MEDICINAL PLANT; METHODOLOGY; NOMENCLATURE; OSTEOARTHRITIS; PARKINSON DISEASE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; RELIABILITY; REVIEW; RHEUMATOID ARTHRITIS; STROKE; VALIDATION PROCESS;

DRUG APPROVAL; EUROPEAN UNION; HUMANS; QUALITY OF LIFE;

EID: 0035116858     PISSN: 11707690     EISSN: None     Source Type: Journal    
DOI: 10.2165/00019053-200119020-00005     Document Type: Review

References (30)

1. Assessment of quality of life outcomes
2. Measuring health related quality of life
3. Standards for validating health measures: Definition and content
4. Measurement of health status
5. Quality of life measures in health care. I: Applications and issues on measurement
6. The Medical Outcome Study: An application of methods for monitoring the results of medical care
7. Generic and disease-specific measures in assessing health status and quality of life
8. Measuring health status
9. The SAC Instrument review process: The instrument review criteria
10. Measuring quality of life in dyspeptic patients: Development and validation of a new specific health status questionnaire: Final report from the Italian QPD project involving 4000 patients
11. Linking clinical variables with health-related quality of life: A conceptual model of patient outcomes
12. From outcomes research to disease management: A guide for perplexed
13. Disease management: New wine in new bottles?
14. Review of the concept of quality of life assessment and discussion of the present trend in clinical research
15. Incorporating quality of life assessment into clinical cancer trials
16. A critical appraisal of the quality of quality-of-life measurements
17. Quality of life bibliography and index: 1993 update
18. Patients-assessed health outcomes in chronic lung disease: What are they, how do they help us, and where do we go from here?
19. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. American Society of Clinical Oncology
20. Commission on outcome measurement in epilepsy 1994-1997: Final report
21. The problem of quality of life in medicine
22. Defining and measuring quality of life in medicine [letter]
23. Quality of life and regulatory issues. Report of a meeting held in Vienna, Austria, November 4, 5, 1997
24. A comparison of the EMEA and FDA draft guidelines in congestive heart failure (CHF) with particular reference to quality of life outcomes