COPD Biomarkers Qualification Consortium (CBQC)
As a result of a workshop convened in 2011, the COPD Biomarker Qualification Consortium (CBQC) was created to help fast track regulatory acceptance of new COPD Drug Development Tools (DDTs) to enable the development of better treatments for COPD. The goals of using these tools are to improve the lives of people with COPD. For example, improved therapies could help stop or slow the worsening of symptoms, reduce the frequency or severity of exacerbation episodes, or ultimately prevent disease in individuals at risk for COPD. Description of the Consortium was published in 2013: Casaburi et al. in the Journal of COPD.
Who were the members of the Biomarker Qualification Consortium?
The COPD Foundation-led CBQC includes many volunteer academic disease experts, biomarkers, health outcomes and imaging experts, and members of Industry who provide scientific expertise, clinical trial data and funding. As described in Merrill D, Rennard S, Tal-Singer R. Lung Health Professional Magazine 2013;4(3): 30-36
Industry members included Astra Zeneca, GSK, Boehringer Ingelheim (founding companies), Chiesi, Novartis and Pfizer.
Each commissioned Working Group was co-chaired by a leader from industry and a leader from academia, and supported by project management, administration and regulatory coordination from the COPD Foundation. Data to support qualification summaries were provided by industry partners, academic researchers and government agencies (specifically studies funded by the National Heart, Lung and Blood Institute and the National Institute of Health in the US).
In 2016 the FDA (and in 2017 the EMA) qualified plasma fibrinogen as the first biomarker qualified for COPD in the US. Publications for this work include:
Mannino et al. Plasma Fibrinogen as a Biomarker for Mortality and Hospitalized Exacerbations in People with COPD. J COPDF 201
Miller et al. Plasma Fibrinogen Qualification as a Drug Development Tool in Chronic Obstructive Pulmonary Disease, Perspective of the Chronic Obstructive Pulmonary Disease Biomarker Qualification Consortium. AJRCCM 2016.
6-min walk distance (6MWD)
The 6MWT data integration and analysis resulted in a decision not to pursue qualification as a COPD DDT as described in the following publication:
Celli et al. The 6-Minute-Walk Distance Test as a Chronic Obstructive Pulmonary Disease Stratification Tool. Insights from the COPD Biomarker Qualification Consortium. AJRCCM 2016
St George's Respiratory Questionnaire (SGRQ)
In 2017, the SGRQ was added to the FDA COA Compendium and a draft guidance for its application as a DDT was issued by the FDA. The work resulted in 6 publications:
Tabberer and Jones The COPD Biomarkers Qualification Consortium St George's Respiratory Questionnaire Manuscripts: Output of a Consortium to Advance Drug Development. JCOPDF 2017
Jones et al. Responder Analyses for Treatment Effects in COPD Using the St. George's Respiratory Questionnaire. JCOPDF 2017
Tabberer et al. The COPD Biomarkers Qualification Consortium Database: Baseline Characteristics of the St. George's Respiratory Questionnaire Dataset. JCOPDF 2017
Jones et al. Baseline Severity as Predictor of Change in St. George's Respiratory Questionnaire Scores in Trials of Long-Acting Bronchodilators with COPD Patients. JCOPDF 2017
Mullerova et al. St. George's Respiratory Questionnaire Score Predicts Outcomes in Patients with COPD: Analysis of Individual Patient Data in the COPD Biomarkers Qualification Consortium Database. JCOPDF 2017
Hardin et al. What's New with the St. George's Respiratory Questionnaire and Why Do We Care? JCOPDF 2017
Jones et al. Socioeconomic Status as a Determinant of Health Status Treatment Response in COPD Trials. JCOPDF 2017
Rennard et al. The St. George's Respiratory Questionnaire Appendix to the Food and Drug Administration Draft Guidance on COPD: Why a Small Step Forward Is so Important. Chest 2017
In 2019, a CBQC Letter of Intent for blood eosinophils was rejected by the FDA following submission of responses to questions from the FDA. In 2020, the AJRCCM accepted a CBQC position paper on blood eosinophils:
Singh et al. Blood Eosinophil Counts in Clinical Trials for Chronic Obstructive Pulmonary Disease AJRCCM 2020
COPD Assessment Test (CAT)
A Drug Master File containing compiled data on CAT was submitted to the FDA and can be referenced for regulatory submissions by contacting the COPD Foundation at firstname.lastname@example.org.
Mullerova et al. COPD Assessment Test (CAT): A Relevant Clinical Outcome Assessment Instrument for Health-Related Quality of Life and Disease Burden in Chronic Obstructive Pulmonary Disease. AJRCCM 2020
The Imaging working group published a manuscript on lung imaging as a biomarker in COPD in Radiology: Ash et al.
A review of Physical Activity Monitoring potential as a DDT was published: Demeyer et al.
View the CBQC Newsletter highlighting the FDA Listening Session, SOS for Breath.