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
Related Articles
- EP ID EP192172
- DOI 10.7365/JHPOR.2015.2.2
- Views 108
- Downloads 0
Healthcare needs maps – evidence informed healthcare policy
Abstract The healthcare system in Poland suffers from some inefficiency in its organization, functioning and financing. In order to implement comprehensive change management in healthcare sector, the Polish Ministry of...
Environmental Determinant of Acute Diarrheal Disease among Under five Children: Unmatched Case Control Study in Babile District, East Hararghe Zone, Oromia Region, East Ethiopia
Introduction: Diarrhea is defined as passing of loose or watery stool for three or more times during a 24 hours period. Diarrhea is one of the leading causes of mortality in developing countries, especially among childre...
Mepolizumab: a new drug programme for patients with severe eosinophilic asthma
Biological treatment involves more and more fields of medicine. This also applies to severe asthma for which a therapy with omalizumab (anti-IgE antibodies for patients with allergic asthma) has been available since 2013...
Cost-effectiveness analysis of methods of diagnosis of tb infection in russian regions by use of recombinant tb allergen in children and adolescents
Background. Russia is among the countries with a high burden of TB. A new diagnostic method for TB has been developed, called ‘recombinant tuberculosis allergen’ or RTA (Diaskintest®), which has a similar cost and method...
Diabetic Macular Edema treatment limits in Poland
iabetic Macular Edema (DME) is a severe disease, related to Diabetic Retinopathy (DR). All diabetic patients are at risk of DME development. The disease severity may vary from mild to moderate, with a risk of loss of vis...