So it was with great excitement that on July 6, 2015, the COPD Foundation announced that the FDA had approved a new clinical biomarker, plasma fibrinogen, for use in clinical trials of patients with COPD.
are broadly defined by the World Health Organization as almost any measurement reflecting an interaction between a biological system and a potential hazard, which may be chemical, physical or biological. The measured response may be functional and physiological, biochemical at the cellular level or a molecular interaction. In clinical research biomarkers are objective, quantifiable signs that can be measured and used to detect disease early, select subjects for clinical trials or even be used as an outcome in clinical trials.
Fibrinogen , a protein measured in the blood, is a promising biomarker which identifies a group representing 25 to 30 percent of all COPD patients.
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 doingif their condition has improved, worsened or stayed the same. Basically, biomarkers are medical signs, tests, or processes that can be used to measure change in the body.
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 effectiveness 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 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, and the patient community to gather and compile information, which already exists, about COPD and COPD research studies. The resulting database of approximately 45,000 studies is believed to be the largest single database of COPD clinical studies available.
Based on the information gathered, the CBQC selected several measures or biomarkers to be considered for qualification first. The initial measures selected were plasma fibrinogen (a blood biomarker), St. Georges Respiratory Questionnaire (a patient reported health status questionnaire), and the 6-minute walk test (an exercise test).
Plasma fibrinogen is the first COPD biomarker to receive qualification by the FDA and is the result of six years of work by the COPD Biomarker Qualification Consortium.
The COPD Foundation Thanks the FDA:
We extend our sincere thanks to the FDA for its qualification of plasma fibrinogen for drug development. The FDA invested resources into this important program so that important tests, biomarkersmeasurescan be used, with confidence, by our researcher and industry partners in the drug development process.
This is a major triumph and on behalf of the entire COPD community, I extend a heart-felt thank you to the FDA and congratulate the CBQC on its tireless leadership that allowed us to reach this significant milestone, said John W. Walsh, founder and president of the COPD Foundation. Through the CBQC, several million dollars and countless hours from pharma representatives, academic researchers, and patients have been spent to create an extensive COPD clinical studies database that led to the FDA s monumental decision to approve this first COPD biomarker.