Evidera would like to extend an enthusiastic congratulations to the COPD Foundation and their Chronic Obstructive Pulmonary Disease (COPD) Biomarker Qualification Consortium (CBQC). Thanks to their efforts over the past five years, the FDA’s updated draft guidance for COPD drug development, “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment,” released May 19, 2016, includes information on the use of the St. George’s Respiratory Questionnaire (SGRQ) as a co-primary or secondary endpoint supporting evidence of efficacy in clinical trials.

The CBQC SGRQ Working Group developed the empirical evidence needed to support the recognition and acceptance of the SGRQ as a key endpoint in drug development trials. The Group included scientists from Evidera, academic clinical research, and industry (AstraZeneca, Boehringer-Ingelheim, Chiesi, GSK, Novartis, and Pfizer). Dr. Heather Gelhorn led the Evidera team, assisted by Dr. Hilary Wilson and other members of Evidera’s scientific and support staff. Evidera was pleased to work with the COPD Foundation and CBQC on this important endeavor, developing and analyzing an aggregated database of 21 studies and over 35, 000 patients with COPD and participating in the interpretation and dissemination of results.

The FDA encourages public comment on this draft guidance and the deadline for submitting comments is July 19, 2016. For more information, click here to contact us.