Is this idea a Compelling Question (CQ) or Critical Challenge (CC)?:
Critical Challenge (CC)
Details on the impact of addressing this CQ or CC:
Much is understood about the pathogenesis of COPD at the cellular and biochemical level. There is no established way these insights can be used to test or implement new medicines. An explicit and economical set of procedures need to be established that will facilitate the development of new medicines and guide their clinical use.
Feasibility and challenges of addressing this CQ or CC:
Many very small studies have identified biomarkers that relate to COPD activity in large groups of patients. There is no clear regulatory path for these insights to lead to tests that can be used with confidence in the development and implementation of novel treatments. Realistic regulatory pathways and criteria should be adopted to facilitate the development biomarkers of disease activity in COPD.
Name of idea submitter and other team members who worked on this idea:
COPD Foundation, COPD Biomarkers Qualification Consortium