Did you know that every prescription medication you have taken in your life started as an investigational medication that had to be approved through a clinical trial? The same is true about every medical device (knee implant, hip implant, etc.). Did you know that none of these life-changing products would be available today without volunteers like you?

Volunteers are vital to clinical trials and clinical trials are vital in helping us make advancements in treatment options for many different diseases and conditions. We are wrapping up the last of our two-part series with the 5 most commonly asked questions asked by potential clinical trial volunteers.

The Top 5

As I previously mentioned in part one, I spoke with thousands of patients. Naturally, there were a lot of questions I was asked. I narrowed them down to the 5 most often asked. Then, I provided a frank, honest answer from my perspective of being a recruitment manager for clinical trials.

Do I need insurance to participate?

    • Most of the time no. The reason I say “most” is because I have worked with some trials that would bill insurance if you had it, but any out of pocket costs, or if you didn’t have insurance would be covered by the trial. This, however, is rare. So again, most of the time, no.

How much will it cost me?

    • Other than your time and getting to the clinical research center for the visits, nothing. Most trials provide reimbursements for time and travel. In one trial we recruited for, they reimbursed the screening visit with a gift card to a local restaurant. Whether or not the trial pays, and how much, is all information given to you beforehand.

If I have a full-time job, can I still do it?

    • I love this question because it is such a common misconception. Some people don’t even consider participating due to this. Many clinical research centers offer extended hours or weekend hours to accommodate patients. This is a question you can ask a clinical research center when you decide to participate.

Why didn’t I qualify for the trial?

    • Every single clinical trial has criteria that outline what type of person is the best to participate. One reason is to keep you safe, but the criteria to participate is also established to define the right population. This will help scientists know if the investigational medication is working.
    • For this reason, they have to define the sample population that provides consistent statistical data.  So, if you don’t qualify, it’s completely out of the control of the research staff. They are required to ensure that only qualified volunteers participate in the trial.   The point is, even if you do not qualify for this trial, you may for another. Check out what else is enrolling in your area!

How safe is it to participate in a trial?

    • Before an investigational medication or device is put into a clinical trial with humans, the product will have undergone rigorous bench testing as well as pre-clinical testing. The results of pre-clinical testing are reviewed thoroughly by the FDA and other third parties before the new product can be tested in humans.
    • Then, volunteers of clinical trials receive very close oversight by doctors and other medical professionals to ensure that they are kept safe in a clinical trial.  Further, all volunteers are fully made aware of any prior possible side effects that may result from the investigational product in the informed consent that they sign when enrolling into a trial.
    • Lastly, if you do experience any side effects, you should immediately inform the research staff. They will take excellent care of you and ensure that you are kept safe.  All medical expenses, if applicable, would be covered and you have the option to stop participating in a trial at any time, for any reason.

Well, that concludes our two-part series. We hope that answering these questions will provide you with the information that you need to make your decision on whether or not to participate. Participating in a trial can have many benefits. Including, but not limited to, education about your condition, possible treatment, close oversight and testing by medical doctors and staff, and compensation for time and travel.

MyLocalStudy is a website where you can see enrolling clinical trials in your area. You can find out more about those trials by submitting a quick application for any trials that you are interested in. To see enrolling trials in your area, CLICK HERE!

References:

https://www.clinicaltrials.gov/ct2/about-studies/learn