In 2017 the Physical Activity Working Group is established, as part of the COPD Biomarker Qualification Consortium (CBQC). The Biomarkers Consortium is created to help qualify new tools to support development of better treatment and medicines that will help improve the lives of those with COPD.
The working group has two sub-streams: (i) FDA qualification of the PROactive instrument, (ii) evaluation of various physical activity parameters available from accelerometry with the aim of selecting the most appropriate parameter for FDA qualification.
McRoberts (one of the technology providers), pharmaceutical companies, academic researchers, and the NHLBI have data from previous clinical studies evaluating various biomarkers. By pooling the existing data, sufficient information may be available to qualify biomarkers so that the Food and Drug Administration (FDA) and European Medicines Agency (EMA) can use them to evaluate new treatments.
McRoberts participates in the Physical Activity discussion with the FDA on the acceptance of the potential physical activity related endpoints for Respiratory.
The consortium is evaluating a range of biomarkers including those that measure an individual’s quality of life, those that measure exercise capacity, specific measures of lung function such as hyperinflation, and blood tests that report inflammation in COPD.
Qualified biomarkers will hopefully provide measures to facilitate the development of new treatments.
The results will be made public in the future. Learn more.