Comparator outcomes profile: need for an informed assessment of secondary outcomes for conducting post-launch observational studies in the HE&OR setting
Journal Title: JOURNAL OF HEALTH POLICY & OUTCOMES RESEARCH - Year 2015, Vol 8, Issue 2
Abstract
Secondary clinical and health outcomes provide additional value and help drug molecule distinguish itself from competitor molecules. Comparator outcomes profile (COP) document in health economics and outcomes research (HE&OR) setting is designed to understand comparative clinical and health outcomes relevant to molecule’s value proposition against select comparators. Generic and disease specific clinical as well as patient reported tools to measure secondary outcomes across geographies are identified from literature and studied to assess their reach and acceptability. Collated summary statistics for key outcomes are presented (tables, figures and listings) by healthcare researchers to help program manager make an informed assessment. COP not only can provide guidance on post-launch observational study design, study endpoint discussion, and indirect comparisons but can also give direction to country organizations in developing their local HE&OR strategy. To conclude, COP can be an important construct in HE&OR setting for molecule’s program development activities.
Authors and Affiliations
Sameer Gokhale
Keywords
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- EP ID EP192172
- DOI 10.7365/JHPOR.2015.2.2
- Views 84
- Downloads 0
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