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?
Before new drugs and treatments can be approved by the FDA, they must be shown to be effective and safe in patients. To do this, researchers need biomarkers which help them assess how well a patient is doing—if their condition has improved, worsened or stayed the same-- or help select subsets of patients most likely to benefit from therapy (phenotypes). Basically, biomarkers are medical signs, tests, or processes that can be used to measure disease activity or disease severity.
In order to help with the drug development process and to address potential roadblocks, the FDA created a “biomarker qualification process.”
This process was 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 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” biomarker. The drug could then be evaluated based on the information generated.
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.
Based on the information gathered, the CBQC selected several potential measures, or biomarkers, to be considered for qualification first. The initial measures selected were plasma fibrinogen (a blood biomarker), St. George’s Respiratory Questionnaire (a patient reported health status questionnaire), and the 6-minute walk test (an exercise test).
The Success of the COPD Biomarkers Qualification Consortium
As of July 6, 2015, plasma fibrinogen has been qualified by the FDA as a COPD biomarker identifying patients at risk for disease worsening for inclusion in clinical trials. 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 first COPD “qualified” biomarker.
The COPD Foundation Thanks the FDA
The COPD community extends its sincere thanks to the FDA for its consideration and qualification of plasma fibrinogen as a tool for drug development. The FDA developed the process and invested resources into this important program so that important tests can be used with confidence, by our researcher and pharmaceutical company partners, in the drug development process. The FDA specifically designed the biomarker qualification process to help speed the development of new treatments, and they are to be commended for initiating this new process.
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 achievement.
Here’s how you can help:
- Sign your name to the “The COPD Community Thanks the FDA” letter.
- Forward the letter to 10 family and friends.
- Share this link on your social networking sites Share This Letter