Patient-reported outcomes in clinical studies
Abstract
About the Author
M. V. LeonovaRussian Federation
References
1. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA 2009.
2. Deshpande P.R., Rajan S., Sudeepthi B.L., Nazir A.C.P. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res 2011; 2: 137-144.
3. McKenna S.P Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. BMC Medicine 2011; 9: 86.
4. Bradley C. Feedback on the FDA’s February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures. Health and Quality of Life Outcomes 2006; 4: 78.
5. Willke R.J. Measuring the value of treatment to patients: patient-reported outcomes in drug development. American health & drug benefits. 2008; 2: 34-40.
6. Willke R., Burke B.L., Erickson P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved labels. Control Clin Trials. 2004; 25 (6): 535-552.
7. Scoggings J.F., Patrick D.L. The use of patient-reported outcomes instruments in registered clinical trials: evidence from ClinicalTrials.gov. Contemp Clin Trials. 2009; 30: 289-292.
8. Patrick D.L., Burke L.B., Powers J.H. et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 2007, 10: (Suppl 2): S125-S137.
9. European Medicines Agency, Committee for Medicinal Products for Human Use (CMHP): Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products London: European Medicines Agency; 2005.
10. Szende A., Leidy N.K., Revicki D. Health related quality of life and other patient reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003. Value Health 2005; 8: 534-548.
11. Meadows K. 5 things you need to know about patient reported outcome (PRO) measures. DHP Research 2012.
12. Valderas J.M., Kotzeva A., Espallargues M. et al. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res 2008; 17: 179-193.
13. U.S. Food and Drug Administration. Guidance for Industry. Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). February 2006. www.fda.gov/CDER/guidance/5460dft/ pdf. Accessed December 11, 2007.
14. Cella D., Hahn E.A., Jensen S.E. et al. Patient-Reported Outcomes in Performance Measurement. RTI Press. 2015; 97.
15. Marshall S., Haywood K.L., Fitzpatrick R. Impact of patient-reported outcome measures on routine practice: а structured review. J Eval Clin Pract. 2006; 12 (5): 559-568.
16. Nelson E.C., Eftimovska E., Lind C. et al. Patient reported outcome measures in practice. BMJ 2015; 350: g7818.
17. Greenhalgh J. The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res 2009; 18: 115-123.
Review
For citations:
Leonova M.V. Patient-reported outcomes in clinical studies. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2016;(2):38-45. (In Russ.)