An Update on Outcomes for COPD Pharmacological Trials: A COPD Investigators Report - Reassessment of the 2008 American Thoracic Society/European Respiratory Society Statement on Outcomes for COPD Pharmacological Trials.
Academic Article
Overview
abstract
BACKGROUND: In 2008, a dedicated American Thoracic Society (ATS)/European Respiratory Society (ERS) task force published a paper on the possible use and limitations of clinical outcomes and biomarkers to evaluate the impact of pharmacological therapy in COPD patients. Since then our scientific understanding of COPD has increased considerably since then, there has been a progressive shift from a one-size-fits-all diagnostic/therapeutic approach to a personalized approach, and many new treatments currently in development will require new endpoints to evaluate their efficacy adequately. OBJECTIVES: The emergence of several new relevant outcome measures motivated the authors to review advances in the field and highlight the need to update the content of the original report. METHODS: The authors separately created search strategies for the literature, primarily based on their opinions and assessments supported by carefully chosen references. No centralized examination of the literature or uniform criteria for including or excluding evidence were used. RESULTS: Endpoints, outcomes and biomarkers have been revisited. The limitations of some of those reported in the ERS/ATS task force document have been highlighted. In addition, new tools that may be useful, especially in evaluating personalized therapy, have been described. CONCLUSIONS: Since the 'label-free' treatable traits approach is becoming an important step toward precision medicine, future clinical trials should focus on highly prevalent treatable traits, which will influence the choice of outcomes and markers to be considered. The use of the new tools, particularly combination endpoints, could help identify better the right patient to be treated with the new drugs.
