Want to learn more about clinical trials?
Are you interested in advancing the knowledge of medicine but scared or unsure of what it means to be a participant in a clinical trial? Let's start by answering a few questions.
Why should I participate in a clinical trial?
Participating in clinical trials is advantageous for two reasons. First, you advance the knowledge of medicine and provide the potential for a better treatment on the market. Not everyone can participate in a clinical trial, and if you have the opportunity, your experience can lead to a new treatment being available to others who were not invited to participate in the trial. Secondly, your treatment is usually paid for and you are typically compensated for your time. In this way, if you are uninsured or underinsured, your treatment may be covered.
Who reviews and oversees the clinical trial?
Every clinical trial must be reviewed by an Ethics Review Board, sometimes called an Institutional Review Board, before participants can be recruited. This means that a team of individuals not connected with the study, and not financially profiting from the study, must approve that the study does not pose a severe medical risk for the patients to be enrolled.
If I experience bad side effects from the medication or device I am using, can I quit the trial?
Yes, you have a legal right to quit the trial for any reason. Any unusual side effects you experience will be reported and listed as potential side effects if the drug becomes FDA-approved.
What does it cost me to be in a clinical trial?
Participation in a clinical trial typically means that the treatments will be covered by the sponsoring organization (that could be a pharmaceutical company, a government agency, or a small business). Though this is not always the case, the majority of the time the treatment, including any required visits to the doctor, are covered by the clinical trial and the only cost is your time.
Can I continue the medications that I am on if I am in a clinical trial?
Medications that are not involved in the treatment of the disease(s) being focused on in the clinical trial can usually be continued during the trial. However, medication for the disease that is to be treated in the trial typically cannot be continued.
What is a placebo, and what could it mean for me?
A placebo is the name for an inactive drug given instead of an actual medication. Placebos are sometimes required in a trial because it is necessary to prove that the drug being given works better than no treatment at all. In a device study, this can mean that the device is a sham (fake), or is not turned on until later once the device has been approved. Placebos can mean that you are not getting any medication. Ask your physician if the trial has a placebo.
What is an “observational study” and why should I do one?
An observational study is one which does not involve treatment with a device or pharmaceutical drug. It is a trial performed to gain a better understanding of the disease without providing a new treatment option. Many observational studies are simple studies involving tissue or blood collection for DNA analysis. By creating a databank of the genomes of individuals with a particular disease, scientists and physicians can later form a better treatment, or a more personalized treatment. By participating in an observational study, you can help advance the knowledge of the disease without changing your current treatment regimen.
Do I need health insurance to participate in a clinical trial?
Generally, health insurance is not necessary to participate in a clinical trial, however, on some occasions it may be required. Ask your physician if you need health insurance for the clinical trial you are interested in.
Still have more questions? Contact us.