When it comes to research, all COPDers should support research programs by either donating or volunteering for clinical trials. The COPD Foundation actively supports research for COPD, illustrating the importance of advancing scientific knowledge. Knowledge can translate into new or improved therapies for COPD, which means COPDers nationwide will have an improved quality of life.
Today, there are thousands of COPD-related scientific research studies going on, with governments sponsoring them and universities conducting them. Pharmaceutical companies also have their own studies to improve or develop new drugs. The only drawback is that when several organizations and institutions are conducting their own research, there could be some overlap.
Since these institutions are working toward the same goal of 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.
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.
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, Dr. Sandhaus says. 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.
Scientists in research institutions (such as universities and pharmaceutical companies) develop the drugs. After they develop it, they go through a series of processes to make sure it works and that it’s safe, among other things. Before they can test it on humans, they have to test it rigorously in the lab and sometimes on animals or human cells. If this is successful, they’ll send their data to the Food and Drug Administration (FDA) to request permission to begin testing on humans.
When the FDA clears the drug for human testing, these institutions set up clinical trials. The testing of clinical trials is done in three phases and each phase involves a larger number of people. The three phases test different things about the drugs; for example, in the first phase, the drug’s safety and effects on the human body are studied. After its safety is confirmed, the drug’s tested for its effectiveness, and if this is confirmed, then it’s tested in bigger trials that include randomized and blinded trials, to make sure the previous findings are correct.
These studies take years and hundreds (maybe thousands) of patients in order to bring about new knowledge about the drug, and possibly a new drug that could help COPDers worldwide breathe better.
This is where we need your help. You may think that these studies don’t need you to volunteer because there are plenty of other people that volunteer. Or maybe you’re unsure about how it works and the process might make you nervous. Participating in a clinical trial is a big deal, and you should weigh your options. There are questions you need to ask before enrolling in a trial, such as how long it will last and if there are any risks involved. (For a list of suggested questions to ask before enrolling in a trial, visit Centerwatch’s website at: www.centerwatch.com.)
But if you are eligible to participate in a trial, please consider doing so. There can never be enough volunteers for these studies; and the more volunteers these studies have at their disposal, the faster they can conduct their research. And ultimately, this speeds up the process for a new drug to be developed for COPD.
Link
Print