There should be no question in anyone’s mind that supporting research for COPD is the only way we’ll get closer to finding a cure. When it comes to research, it’s every single COPDer’s responsibility (yes, that’s means duty) to support research programs by either donating or volunteering for clinical trials. (Next Monday, I’ll have some information for you about understanding clinical trials so be sure to check back.)
The COPDF is actively supporting research for COPD—so there’s no question we understand the importance of advancing scientific knowledge. We know that knowledge can translate into new or improved therapies for COPD. And we know that means COPDers nationwide will have an improved quality of life.
It’s important for you to understand that the world of scientific research is more than just a couple guys in lab coats fussing around with a Petri dish and microscope. There are thousands of COPD-related scientific research studies going on around the world today. Governments are sponsoring some research studies, and universities are
COPD Biomarkers Workshop, January 2010
conducting others. Pharmaceutical companies also have their own studies to improve or develop new drugs. This is great! But when several organizations and institutions are conducting their own research, there is some unnecessarily overlap. Some people might be working on a similar project or someone might have found something that can help someone else in their study.
Because these institutions are working toward the same goals (finding a new or improved therapy for COPD) they all have to follow similar procedures to ensure that the results they get in their study are correct. In order to say that a therapy is effective, researchers must prove (among other things) that the biomarkers they measured are relevant in a clinical setting, that they were affected by the proposed therapy, whether it’s a long term or short term benefit, and whether the results can be duplicated and confirmed.
Essentially, they have to make sure what they found isn’t a fluke.
“The progression of COPD sometimes moves at glacially slow speeds [and] drugs that affect the course of COPD may take years to demonstrate their beneficial effects at slowing the progression of disease or improving it,” says Dr. Robert Sandhaus from National Jewish Health. “Biomarkers allow researchers and drug companies to see these beneficial effects in a much shorter time frame.”
Biomarkers help researchers keep track of any changes in the body that the new drug could be causing. In COPD research, some biomarkers used include the exercise tests, breathing tests, CT scans, your answers to the quality of life questionnaire and your lab results.
How do biomarkers help researchers see the effects of a therapy in a quicker way? “For instance,” says Dr. Sandhaus, “if an anti-inflammatory drug were to work at reducing inflammation in the airways, it could take years before this results in a slowing of lung function decline or an improvement of quality of life in a study. But if inflammatory biomarkers are turned off in the airways of people receiving the drug, this could be measured in days or weeks—and give researchers a good indication that its worth pursuing this as a target for drug development.”
Processes can really dictate how studies go, so efforts to help improve the processes by which studies are conducted can tremendously help speed up the time it takes to get drugs developed, approved and in the market for you to use.
Earlier this year, the COPDF hosted a workshop for qualifying biomarkers. For the workshop, we brought together universities, pharmaceutical companies, and the FDA into a room to talk to each other about the biomarkers.
Everyone agreed that individual biomarkers could be used effectively in developing drugs. The process for showing that a new biomarker is useful for measuring a disease can take decades and hundreds of studies to get enough data. But rather than waiting for individual institutions to conduct hundreds of studies, the scientists shared their own data on different biomarkers.
Carrying on the work of this workshop a group of companies and universities have formed a consortium to work together and determine from the shared data, which biomarkers might really work. That set of data and biomarkers can then go to the Food and Drug Administration (FDA) for their review. The new biomarkers could then speed up the process of determining which therapies work.
This might sound too technical, but it’s huge. Like I mentioned before, there are a lot of research studies being conducted at the same time, so it’s important to align them as much as possible so that you, the patient, can get access to better drugs that will help you breathe better and live better.
Keep in mind what you just learned. Researchers are always looking for COPDers, like you, to volunteer for clinical trials. Remember that the drugs your using were only made possible by COPDers before you who volunteered for studies.
Sign up today to be in the registry to help find a cure.
