Frequently Asked Questions About Clinical Trials

If you agree to participate in a clinical trial, you might receive a trial treatment or something else, such as a placebo, which looks or tastes like a treatment but does not have any actual treatment in it. You also might get a treatment that is already approved for public use.

Participants do not get to choose which treatment they get, and the treatment each participant gets is usually decided randomly. The treatment may be given as a pill, injection, infusion, or in other ways.

In some trials, you might only give permission for researchers to collect health information through surveys or medical records. Some clinical trials include “healthy” participants, who do not have the condition the trial is studying.

You may need to visit the trial site for tests and treatment and for doctors to check on your health. These visits can also be at your home or through telemedicine.

A placebo looks like a treatment but does not have any medicine in it. Researchers use placebos to help make sure any changes in the participants’ health are actually caused by the trial treatment. You do not get to choose if you get the trial treatment or the placebo, and you may not know if you get the placebo until after the trial. Not all trials use a placebo.

A participant who gets the placebo might suddenly feel better because they thought they got a real treatment. This is known as the placebo effect. Researchers compare the results of participants who took the placebo with the results of participants who took the trial treatment. This helps them learn how the trial treatment works and if it’s safe.

Usually, the participants do not know that they are taking the placebo. Sometimes the doctors also don’t know, which helps them treat each participant the same.

Trials can last weeks, months, or even years. The number of visits and how long you may be in the trial overall can be different for every trial. You may need to visit the trial site for tests and treatment, and for doctors to check on your health. These visits can also be at your home or through telemedicine.

There is a lot of preparation that takes place before a trial starts, and trials need more review after all the participants have left. It can take many years before a treatment is approved and ready to be used by the public.

Participants can leave a trial at any time and for any reason.

All clinical trials must follow federal laws and ethical guidelines. Trials must also be approved by an expert group called an institutional review board (IRB) that helps make sure the trial is fair and as safe as possible, and that any risks to the participants are worth the potential benefits.

Every trial must also have a protocol, which is the overall plan for the trial that includes instructions that the doctors and staff doing the trial must follow. This protocol must be approved by an IRB.

You can take as much time as you need before deciding. It is very important to understand a clinical trial and to be comfortable with what is planned to happen before you agree to participate.

Being in a trial is optional. Agreeing to be in a trial does not take away any of your rights. You can stop being in a trial at any time and for any reason. The trial staff will help you do this safely. You can talk to the trial staff or the IRB anytime you have concerns about being harmed.

It’s very important to understand a trial before joining. Researchers are not allowed to give you treatment in a trial unless you fully understand what is going to happen.

Every clinical trial has a process where the trial doctor and research team go over what happens in the trial and reasons you may or may not want to join. The trial doctors and research team will explain what treatments you might get, how long the trial is expected to last, what happens during visits, the potential risks and benefits, and many other important facts about the trial. This process is known as informed consent.

You must read and agree to an Informed Consent Form before you participate. You will get a copy of this form. As a potential participant, you can ask as many questions as you want before signing the Informed Consent Form.

Yes. Being in a trial is optional. You can stop being in a trial at any time and for any reason. The trial staff will help you do this safely.

Yes. Participants should still see their primary care doctor to make sure they get all the usual treatments they need. Primary care doctors can work with the research team to make sure that a participant can keep taking their other treatments.

No. Standard of care is treatment that has already been tested and approved by the government. In other words, doctors know how a standard of care treatment works. The trial treatment in any trial is still being tested, so doctors and researchers don’t know enough about how it works or how safe it is yet.

It is extremely important to understand a trial before you agree to participate. Plan ahead by making a list of questions to ask the research team. Talk to family, friends, counselors, and other people you trust. Talking to people with different views and information can also help. You can ask a friend or family member to come along for support and to help you understand the trial.

See below for important questions to consider.

Every clinical trial is different. You should ask as many questions as you need until you fully understand what to expect in a trial. Here are some examples:

Questions to Ask Yourself

Do I want to participate? Why or why not?
Does participating fit with my values, beliefs, and preferences?
What would I like to get out of participating?
What amount of risk am I willing to take? Do the possible benefits outweigh the risks?
Do I have enough time to participate?
Would I need to arrange for child care or for the care of another family member if I participate?

Questions to Ask a Healthcare Professional

What are the possible risks and benefits of participating?
How would the risks and benefits of a trial treatment compare with my current treatment?
How might participating affect my daily life?
Would I have to pay for any part of a clinical trial? Will my insurance cover these costs?
What are the current treatment options for my condition?
Are there any clinical trials that would be a good option for treatment?
Can I get the materials in a language I want? Can I get a translator?
Will you be part of my care team if I participate in a clinical trial?

Questions to Ask Family, Friends, and Others You Trust

Can you attend doctor visits with me to help make sure I understand everything?
Can you take notes and help me organize the information I get during doctor visits?
Would you be able to watch my kids, pets, or house while I go to appointments?
Would you be able to give me a ride if I need it?
What do you think about me participating in a clinical trial?
What do you think about clinical trials in general?
Ask questions until you feel comfortable. Once you have asked all your questions and have all the information you need, you might want to make a list of pros and cons. This can help you make an informed decision about participating in clinical research.

Some potential risks if you participate are:

The treatment in the trial may not help you.
You may have side effects from the trial treatment.
You may have frequent testing or blood draws.
You may need to set aside time for participation.

Some potential benefits if you participate are:

You will help researchers learn more about how a treatment affects your community.
You may have early access to advanced treatments for your condition.
You may have access to treatment when no approved treatment exists.
Your health will be watched by the trial doctors and nurses.

Some trials pay for travel costs, time, and commitment. But not all do. Each trial will have its own guidelines that tell you if you will be paid and what costs will be covered. Check with your trial doctor and the research team to confirm.

Payments in trials are made for your time and possible inconvenience of participating in the trial. These payments are also called compensation or stipends. The amount is usually based on the trial length, number of visits, the types of procedures, and other factors.

See our Guide to Costs and Payments in Clinical Trials brochure for more details on payments.

If you have a specific condition, the patient advocacy organization for your condition may have a list of clinical trials. Your doctor may also know about clinical trials for your condition. If you would like to learn more about current clinical trials, call 1-877-MED-HERO.

The website https://www.clinicaltrials.gov/ is run by the National Institutes of Health (NIH). It provides education about clinical trials and lists many of the open and recruiting trials taking place in the United States in both English and Spanish.

If you are ready to find trials in your area, CISCRP’s free service will provide a list of relevant trials. Go to https://www.ciscrp.org/services/search-clinical-trials/ or call 1-877-MED-HERO.

Always talk to your trusted doctors, family, and friends before making a decision about joining.

You can find results from past clinical trials on the website https://www.clinicaltrials.gov/. Some sponsors post results on their own websites. The European Union (EU) also posts plain language summaries for trials that take place in any EU member state. You can search for these summaries on this website: https://euclinicaltrials.eu/search-for-clinical-trials.

As a participant, you are entitled to a plain language summary of the results of your clinical trial once the trial is finished. CISCRP works with research sponsors to make these summaries. If you do not have access to a summary, check with the trial doctor or research team.