Key result
This paper outlines the U.S. regulatory perspective on determining and using minimally clinically important differences (MCID) to assess outcomes for COPD therapies.
Provides a U.S. regulatory perspective on the use of minimal clinically important differences (MCID) for evaluating COPD therapies.
Answers are grounded in this paper and cite their sources.
Regulatory MCID guidance warrants attention in COPD trial interpretation; leaves open standardization across endpoints and populations.
This paper outlines the regulatory issues surrounding the determination and use of minimally clinically important differences (MCID) in assessing measures of outcomes from treatments of chronic obstructive pulmonary disease (COPD). To place this discussion in context, it is important to understand the current state of approved therapies for COPD, as well as newer directions in therapy. This paper discusses the currently available, approved drug therapies for COPD in the United States and how they were approved. This is followed by an overview on the use of MCID for assessing outcomes in therapies for COPD, as well the more general experience with MCID from the U.S. regulatory perspective.
No takes yet. Share an insight, caveat, or question.
Robert J. Meyer (2005) conducted a review in Chronic Obstructive Pulmonary Disease (COPD). COPD therapies was evaluated. This paper outlines the U.S. regulatory perspective on determining and using minimally clinically important differences (MCID) to assess outcomes for COPD therapies.
Synapse has enriched 10 related papers. Consider them for comparative context: