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Incorporating pharmacoeconomic and health outcomes into randomized clinical trials.
MedLine Citation:
PMID:  19807612     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Clinical trials represent the most scientifically valid study design for evaluating the safety and efficacy of new medical treatments. However, for pharmacoeconomic outcomes, the usual efficacy clinical trial may not always provide the appropriate vehicle for generating information on the cost-effectiveness of medical treatments. Pragmatic, or naturalistic, clinical trials may be more suited to understanding cost-effectiveness. There are several issues associated with designing clinical trials that include patient-reported outcomes or pharmacoeconomic outcomes. For patient-reported outcomes, it is important to match the domains and instruments with the objectives and characteristics of the target patient population, examine psychometric characteristics (i.e., reliability, validity and responsiveness) when selecting measures, and also consider practical issues related to data collection. Plans need to be put into place to minimize missing patient-reported outcome item level and form data. For pharmacoeconomic outcomes, it is necessary to collect healthcare resource data and to value these resources in some way. This may be challenging when multinational clinical trials are designed and conducted. There are challenges associated with the analysis of cost data and in conducting cost-effectiveness analyses. Design and reporting of prospective, pharmacoeconomic trials will help inform evidence-based medicine and hopefully improve the delivery and outcomes of medical care.
Authors:
Dennis A Revicki; Clark Paramore; Anne M Rentz
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Expert review of pharmacoeconomics & outcomes research     Volume:  5     ISSN:  1744-8379     ISO Abbreviation:  Expert Rev Pharmacoecon Outcomes Res     Publication Date:  2005 Dec 
Date Detail:
Created Date:  2009-10-07     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101132257     Medline TA:  Expert Rev Pharmacoecon Outcomes Res     Country:  England    
Other Details:
Languages:  eng     Pagination:  695-703     Citation Subset:  -    
Affiliation:
MEDTAP Institute at UBC, Center for Health Outcomes Research, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA. dennis.revicki@unitedbiosource.com.
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