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 98
- Downloads 0
The access to an ophthalmic treatment in Poland on the example of the ocular complications in the course of diabetes mellitus
Background Diabetic Retinopathy (DR) is the severe disease, that develops as a result of diabetes complication. All diabetic patients are at risk of DR development and the National Health Fund (NHF) estimates that ther...
The disposal of unused and/or out of date medications in the community pharmacy setting in Poland – a challenge for pharmaceutical public health and pharmaceutical care
It has been proven that even small concentrations of certain drugs in the environment can be toxic to plants, but also fatal for animals and humans. The only proper way to prevent this phenomenon is to minimize the adver...
Drug policy as an integral part of state health policy - international examples
Medicines policy plays a major role in protecting, maintaining and restoring people’s health and is an integral part of state health policy. It embraces brand and generic drugs, biologics, vaccines and natural health pro...
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...
The study of the need for interprofessional collaboration in the health care system in Poland - experience of Lesław A. Paga Foundation.
Background: Interprofessional collaboration (IC) in healthcare is a process by which professionals from different disciplines collaborate to provide an integrated and cohesive approach to patient care. The Lesław A. Paga...