What to expect during a clinical trial

Wondering what it’s like to take part in a clinical trial? This page takes you through what to expect during a clinical trial and at your study visits.

What kinds of activities could I be asked to do during a clinical trial?

Most of the time, you’ll need to go to in-person study visits during a clinical trial. Some visits might be done by video or phone. The study team may also call you to check in or ask you to do certain things at home.

Here are some examples of what you might be asked to do:

Get a physical exam
Have your blood drawn
Take tests like an electrocardiogram to check your heart
Answer questions about your health and how FSHD affects your daily life (some questions may be personal, like about your mental or sexual health)
Do tests to measure your strength, how well you move, or how far you can reach
Get an MRI scan
Have a muscle biopsy
Take your medicine at certain times
Let the study team know if you feel sick, get hurt, or have any side effects

These activities help the study team understand how the treatment is working and make sure you’re staying safe.

How to get ready for a study visit

Study visits can take a long time—sometimes a whole day or more. You’ll be asked lots of questions and will probably do many tests. Planning ahead can help make the visit easier and less tiring.

Here are some tips to help you get ready:

Write down any questions you have and bring the list with you.
Wear comfy clothes that are easy to move in and easy to take off, in case you need to change for a test like an MRI.
Bring snacks and water. You’ll probably get hungry or thirsty. You’re doing something important, so treat yourself! Bring extra snacks for your care partner or friend if they’re coming along.
Charge your wheelchair or scooter the night before if you use one.
Bring entertainment like movies, music, or books on your phone, tablet, or laptop to help pass the time while you wait.

What happens if the medicine makes me sick?

One goal of clinical trials is to find out how safe a new medicine is. The study team may not know all the side effects yet, which is one of the risks of joining a trial. But clinical trials have strict rules to help make the medicine as safe as possible.

If the medicine makes you feel sick, the study team will write down what happened. They will decide if it’s safe for you to keep taking the medicine or if you should stop. They will also help make sure you get the medical care you need. In some cases, your health insurance might have to pay for that care. The informed consent form will explain what is covered and what is not.

Costs and payments

Will I have to pay to be in a clinical trial?

No, you usually won’t have to pay anything to be in a clinical trial. But there may be indirect costs to think about. For example, you might need to:

Take time off work
Find childcare
Change travel or social plans to attend study visits

Will I get money back for travel?

Yes, most clinical trials will pay you back for reasonable travel costs. This might include:

Gas or public transportation
Economy flights
Hotel stays
Food

Talk to the study team about your travel plans and ask what they can cover.

Will I get paid for being in a clinical trial?

Some trials may offer a small payment (called a stipend) for each visit or at the end of the study. Ask the study team if they offer any payment for your time.

Check out more FAQs about what to expect during a clinical trial

What is an adverse event? What if I experience one?

An adverse event is any medical problem that happens while you are in a clinical trial. It can be something small or more serious. Some examples include:

Catching a cold
Getting a bruise after a blood draw
Having a headache after taking the medicine
Getting a test result that isn’t normal
Tripping and falling at home
Feeling very tired

An adverse event might not be caused by the medicine or the trial, but it still needs to be reported.

Always tell your study team if anything unusual happens, even if you don’t think it’s related to the trial. They need to keep track of all events to make sure the trial stays safe for everyone.

Who makes sure patients are safe during a clinical trial?

Your safety is very important during a clinical trial. The study team keeps a close eye on your health and reports anything unusual, like side effects or other problems.

There are also outside experts, such as:

Clinical Monitors, who check that the trial is being done correctly
Data and Safety Monitoring Boards, who review safety data to make sure the trial stays safe

Finally, big health agencies like the FDA (in the U.S.) and the EMA (in Europe) help guide the study teams and must be told right away if there are any serious safety concerns.

Do clinical trials provide medical care?

Most clinical trials will give you medical care for any urgent problems that happen because of the trial. But they usually do not provide:

Regular checkups
Full medical care for other health issues
Long-term care

It’s important to keep seeing your regular doctor(s) while you’re in a clinical trial. They will help take care of your overall health.

Should I keep seeing my doctor while in a trial?

Yes, you should keep seeing your regular doctor(s) during the clinical trial. It’s also a good idea to let your doctor know that you’re in a trial. Sometimes, the study team may want to talk to your doctor or work together to help manage your care.

Can I quit in the middle of a trial?

Yes, you can stop being part of a clinical trial at any time and for any reason. It’s your choice, and you won’t get in trouble or need to explain why.

But before you join a trial, think carefully about whether you can commit to the whole thing. Clinical trials take a lot of time, money, and effort to run. If too many people drop out, it can affect the results or even stop the trial.

If you’re thinking about quitting, talk to your study team first. They can help answer your questions and talk through your concerns.