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Postapproval Development Options in COPD: A Case Study in Value-Based Healthcare Systems.
Michael F Murphy1, Paola Antonini2, Zhihong Vicki Lai3
1Chief Medical Officer and Scientific Officer, Worldwide Clinical Trials, King of Prussia, PA, and Research & Development Editor for American Health & Drug Benefits.
American Health & Drug Benefits
|August 16, 2014
Summary
Developing novel therapeutics globally requires research programs that consider diverse stakeholders. Chronic obstructive pulmonary disease (COPD) serves as a model for optimizing clinical trial data for international registration and market access.
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Area of Science:
- Clinical trial design and methodology
- Global pharmaceutical research and development
- Health economics and outcomes research
Background:
- Globalization introduces complexity in R&D with diverse stakeholders.
- Novel therapeutics require research aligned with registration, payers, pricing, and marketing.
- International R&D necessitates adaptable and transparent data generation strategies.
Purpose of the Study:
- To present a framework for clinical development programs.
- To integrate multiple stakeholder perspectives into study designs.
- To create optimal data platforms for diverse audiences in drug development.
Main Methods:
- Utilizing chronic obstructive pulmonary disease (COPD) as a case study.
- Analyzing COPD prevalence, costs, and treatment diffusion.
- Illustrating methods for informing registration and technology assessments.
Main Results:
- COPD's characteristics make it suitable for demonstrating stakeholder-informed trial methodology.
- International trial dimensions highlight system complexities and broad issues.
- The proposed approach facilitates data evaluation across various perspectives.
Conclusions:
- Contract research organizations offer unique insights into international clinical research.
- A strategic approach to clinical development can address global R&D challenges.
- Methodologies demonstrated with COPD can be applied to other therapeutic areas.