Remember that a clinical trial involves risk - at the very least, the proposed treatment might not work. But it could also cause harm, and even, though rarely, death. So ask!
First, some things to think about up front:
- How will this fit into my schedule?
- What am I planning or hoping to get out of participating? (Find a better treatment for me, help all pwp, etc.)
- What matters to me the most about participating in this trial?
- What does my own doctor think about how this might fit into my care plan/safety/etc?
- What is the study trying to accomplish?
- Who, exactly, is conducting this research? (For example, is it being done for a drug company?)
- What have these researchers (and others) found out about this treatment?
- Have the results of previous research been published? (If not, why not?)
- What risks are there, and what are the possible benefits?
- Is there a placebo? (The equivalent of a sugar pill, a placebo helps determine what reaction is due to "placebo effect" - hopefulness that this will work vs. how well it really works.) If I receive a placebo, will I have the opportunity to receive the real treatment later on? How does a placebo work in the case of a surgical study?
- How long will the study go, and how often will I be needed?
- What form will the treatment take? (pill, shot, surgery, specific exercise...)
- What other tests are involved? Do these tests involve risk? Pain? Who will conduct these tests? (For example, if a spinal tap is being done, what are the risks from this test, and how much training/experience does the person have who will conduct the test?)
- How will my privacy (health, personal information, test results, etc.) be protected?
- What will happen at each visit?
- If I decide to leave the study early, what needs to happen? (for example: slow reduction of drug, surgical removal of hardware)
- What happens if my condition gets worse, or I am injured/made sick because of the trial? Who will pay for my care?
- What if I have an adverse reaction when I'm away on vacation? Who should I see for care? If I need an emergency room visit, will I be reimbursed for the cost?
- Will any travel costs be paid for, and if so are there limits on distance?
- How about taxis or meals?
- Is the location where the study takes place in my insurance network? If not, will the study pay costs for tests that insurance would usually cover?
- If there are any lab tests that help the study but are not "medically necessary" who will pay for these tests?
- Is there a copay cost to see a specialist/specialists that I will need to pay?
- If my insurance is needed to pay for some costs, who will submit the costs to insurance?
- What happens after the study?
- Is there follow-up care needed? Who will provide that, and who will pay for this care?
- Will I have access to test results, and to whether I received placebo or active therapy? When will this information be available?
- Is there a way for me to continue to take the drug/use the device after the trial is over, if it helps me? Who will I need to speak to?
Just came across this, written by Simon Stott (The Science of Parkinsons blog) about some rules to follow once you're in a clinical trial.
Image from Pixabay.
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