Contributed by Jim Nelson, consultant to CAIRE Inc. ~
If you have done any research about your disease, you have likely run across promotional material about clinical trials. What are they all about? Should you get involved?
Clinical trials are utilized by medical equipment manufacturers and drug companies in order to evaluate the results of the use of their product. The information gathered is used to refine research and especially to seek the approval of governmental agencies so that they can market their product legally. The conduct of the trials varies widely, but they generally involve the recruitment of people who are suffering from a particular disease or disorder. A great many of the trials split the participants into two groups; those who receive the medicine or treatment being studied, and those who receive some manner of placebo. A placebo is a harmless pill or other substance that has no medical effect but is used in place of the product being studied so that the researchers can get an accurate read on the effects of their product.
Trials last for months or years, depending on the length of time it takes to properly evaluate the results. In addition, there may be more than one phase to a particular trial.
Perhaps most importantly, the vast majority of clinical trials do not charge the participant! Rather, they will often offer some compensation for the time and trouble of the patient. These clinical trials are vital to the development of medications and medical equipment.
Check the U.S. National Library of Medicine’s listing of privately and publicly-funded clinical studies. The site currently lists 310,644 research studies worldwide. If a trial is listed on the site, it should also tell you who is sponsoring it. If it is a name that is unfamiliar to you, or if a sponsor is not listed, do some investigating into the sponsor. Read their disclaimer and also check the “Know the risks and potential benefits” section.
Has the trial been approved by an Institutional Review Board? That is a step that must be taken before a trial can proceed. Check whether the Office for Human Research Protections has registered approval of the trial.
Another important step is to check to see whether your insurance company will cover the cost of the trial that you are investigating. How about the routine transportation and living costs? If the trial is not approved, your insurance company will likely decline to pay for any of it.
So, if you are interested in a clinical trial, do some research, find out as much as you can about it, and make your decision whether you want to get involved. Ideally, you will help yourself and others of your particular disease community. Thanks in advance.
~ Uncle Jim
Jim Nelson is a double lung transplant recipient and a patient advocate for COPD patients throughout the U.S. and around the world. He and his wife, Mary, are well known patient advocates and brand ambassadors for those organizations who tirelessly endeavor to help those individuals who suffer from a variety of respiratory diseases and the caregivers who support them.
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