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 83
- Downloads 0
The adaptation of new methodology of quality of life assessment in patients with thrombocytopenia in Ukraine as a result of Polish-Ukrainian collaboration
Objective. Our aim was linguistic adaptation the Thrombocytopenia Symptoms and their Impact on patients Daily Activities Assessment Vignette (TSIDAV) into Ukrainian. Methods: In the translation process were involved two...
Idiopathic Pulmonary Fibrosis as a Challenge for the Polish Healthcare System
Idiopathic pulmonary fibrosis (IPF) is a rare disease characterised by age-dependent incidence, unclear aetiology and progressive course. Given the complexity of the diagnostic pathway and limited therapeutic options, an...
Patients' opinions on metoprolol, as expressed on the Internet - an exploratory, qualitative study
Background Use of the Internet in health communication provides an opportunity for more effective discussions, consequently Internet forums are potential sources of drug-related information for the patients. However, we...
Cost-utility analysis and budget impact analysis of pegvisomant for the treatment of adult patients with acromegaly in Poland
Background: The aim of this publication was to evaluate the cost-effectiveness and financial consequences of pegvisomant (PEG) in the treatment of adult patients with acromegaly, who have had an inadequate response to su...
Multiple Criteria Decision Analysis (MCDA) for Health Care Decision Making – overview of guidelines
Multidimensional context of decision making in health care implies the need for structured approach which can be supported by Multiple Criteria Decision Analysis (MCDA). Despite the fact that MCDA is more widely discuss...