COPD Biomarker Qualification Consortium Thanks the FDA
What is a COPD Biomarker Qualification?
On average, 1 American dies from COPD every 4 minutes, yet no treatment has been developed that actually modifies or alters the course of COPD. Although there are impactful medicines that improve the well-being of patients with COPD, in the last 3 decades, only 1 new class of drug has been approved. One of the main reasons novel mechanisms have not been developed is that drug companies have not had assurance that drugs developed for specific patient groups or subsets (“phenotypes”) will be approved by the Food and Drug Administration (FDA)—because of concerns about how the drug’s efficacy is measured or because clinical trials required for approval are large and take a long time: drug development in COPD requires a great investment for companies and for clinical trial participants.
Why is COPD Biomarker Qualification important?
Qualification is a process by which regulatory agencies can evaluate a biomarker and determine if it can be used in clinical trials that support regulatory submissions for the approval of new treatments. Qualified biomarkers may greatly accelerate the process of bringing new therapies to patients, as they may detect improvements in COPD sooner than traditional methods, and hence allow an evaluation of a new therapy in less time that would be possible using traditional methods, or they may allow a trial to be much smaller and therefore be completed sooner, potentially accelerating the development of new treatments
The FDA Drug Development Tools qualification process which is intended to facilitate drug development by creating rigorous standards for biomarkers that could be used in drug development programs, such that when applications for new drugs are filed by companies, the biomarkers used to evaluate them would already be accepted by the FDA. In other words, the new drug application would not be rejected because the biomarker or clinical outcome measures used to measure its efficacy or to identify patients likely to benefit from therapy was determined to not be appropriate or to not be a “true” measure.
In 2010 the COPD Foundation, with encouragement from the FDA, established a group consisting of pharmaceutical companies and academic investigators called the COPD Biomarker Qualification Consortium (CBQC). The CBQC assembled representatives and resources from industry, university and government (NIH) researchers, as well as the patient community to gather and compile existing COPD clinical research trial information. The resulting database of approximately 45,000 patients is believed to be the largest single database of COPD clinical studies available.
The Success of the COPD Biomarkers Qualification Consortium
As of February, 2020, plasma fibrinogen has been qualified by the FDA as a COPD biomarker identifying patients at risk for disease worsening for inclusion in clinical trials and this was the first COPD “qualified” biomarker in the US. The St George’s Respiratory Questionnaire (SGRQ) was subsequently accepted as a qualified measure of health status (how a patient feels). There are ongoing efforts to qualify exercise outcomes, blood tests and imaging biomarkers. Several million dollars and countless hours from those working in the pharmaceutical industry, academic researchers and patients have been spent to create the database and do the analyses which led to approval of this.
How Do I Take Action?
We need our entire community: patients, caregivers, physicians, researchers, nurses, respiratory therapists, pharma reps and everyone who supports COPD research to join us in bringing attention to this effort.
Here’s how you can help:
- Share the news about the CBQC with your family and friends using this link