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Outcomes for COPD pharmacological trials: from lung function to biomarkers
M Cazzola1, W MacNee, F J Martinez
1Unit of Respiratory Diseases, Dept of Internal Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy. mario.cazzola@uniroma2.it
The European Respiratory Journal
|February 2, 2008
Summary
The American Thoracic Society and European Respiratory Society created a task force to evaluate outcomes and biomarkers for chronic obstructive pulmonary disease (COPD) drug trials. This guide clarifies their use and limitations in assessing pharmacological therapy effectiveness.
Area of Science:
- Pulmonary Medicine
- Clinical Trial Design
Background:
- Chronic obstructive pulmonary disease (COPD) management relies on evaluating pharmacological therapies.
- Current outcome measures and biomarkers in COPD clinical trials require critical assessment.
Purpose of the Study:
- To inform the COPD research community on the utility and constraints of existing outcomes and biomarkers.
- To guide the selection and interpretation of endpoints in COPD pharmacological trials.
Main Methods:
- Joint creation of a Task Force by the American Thoracic Society and European Respiratory Society.
- Comprehensive review of published literature on COPD trial outcomes and biomarkers.
Main Results:
- Identification of specific outcomes and biomarkers relevant to COPD pharmacological trials.
- Detailed discussion of the strengths and limitations of each outcome and marker.
Conclusions:
- Recommendations provided for the appropriate use of outcomes and biomarkers in COPD research.
- A framework for evaluating pharmacological interventions in COPD is established.
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