Pharmacovigilance

ISPOR PRO Task Forces (http://www.ispor.org/taskforces/tfindex.asp.) examples below:

• Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force. http://www.ispor.org/workpaper/PROchildrenadolescents/Matza_et_al_2013_…
• Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation http://www.ispor.org/workpaper/research_practices/PROTranslation_Adapta…
• Use of Existing Patient-Reported Outcome (PRO) Instruments and Their Modification:TheISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PROTaskForce Report http://www.ispor.org/taskforces/documents/Rothman.pdf
• Clinical Outcomes Assessment –Emerging Good Practices Task Force. http://www.ispor.org/TaskForces/Clinical-Outcomes-Assessment.asp
• Liu, Eggleston, HU. Emerging Health Economics and Outcomes Research in the Asia-Pacific Region. Values in Health 11 suppl. 1 2008 S1-SS2
• Draft and Final Guidance to Industry (FDA) http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf
• EMA Reflections Paper http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500168852.pdf
• de Vet, H. C., C. B. Terwee, et al. (2006). "Minimal changes in health status questionnaires: distinction between minimally detectable change and minimallyimportant change." Health QualLife Outcomes4: 54.
• Deyo, R. A., P. Diehr, et al. (1991). "Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation." Control ClinTrials12(4 Suppl): 142S-158S.