How clinical trial safety works
Clinical trials are only possible because people volunteer to take part. Keeping people safe is always the top priority for clinical trial teams.
Doctors explain how patient care and safety come first
You can use our guide to talking to your doctor about clinical trials, including questions about safety and patient consent. Save this list and bring it to your next appointment.
Key facts about clinical trial safety
Clinical trial safety is a team effort
Many different people work together to help keep clinical trials as safe as possible before, during, and after. Learn more about who is responsible for safety in clinical trials.
Safety planning starts long before a trial begins
Before a clinical trial can start, it goes through several layers of expert and ethics review to help make sure it’s safe to move forward. Learn more about planning and monitoring for safety.
Most clinical trials don’t use placebos alone
In clinical trials, participants are randomly placed into different groups. What each group receives depends on the trial design. When an effective treatment already exists, participants usually receive the current standard of care and a potential new treatment—not a placebo.
You may hear concerns about not getting any treatment, but all participants receive medical care and close monitoring throughout the clinical trial, no matter which group they are assigned to. Learn more about placebos and randomization in clinical trials.
You have rights, and informed consent helps protect them
Before joining a clinical trial, you have the right to understand all key details about what’s involved. The informed consent process explains possible risks, potential benefits, and your responsibilities so you can make an informed decision about joining. You also have the right to leave a trial at any time, even after it starts. Learn more about informed consent.
Your health is closely watched during a clinical trial
Throughout the trial, your healthcare team regularly checks in on your symptoms, lab results, and overall health. They keep an eye out for side effects and report any concerns to safety oversight groups. Learn more about potential risks.
Clinical trials need to include people from many backgrounds to improve safety
People can respond differently to treatments based on a range of factors. That’s why it’s important for clinical trials to include participants from different backgrounds—so researchers can better understand those differences and improve safety for everyone. Learn more about how inclusivity leads to safer treatments.
Safety facts and fiction
When it comes to clinical trials, it’s important to separate fact from fiction. This can help you make a more informed choice about participating. Let’s start by clearing up four misconceptions about clinical trials.
FICTION: Potential treatments are untested.
FACT: A potential treatment can be given to people only after healthcare providers have an idea of how safe it will be. The first tests, called pre-clinical tests, are done in a laboratory. The results are reviewed to find out if the potential treatment is safe to test in clinical trials.
Watch the video to learn more about potential treatments.
FICTION: Trial teams aren’t real healthcare providers.
FACT: Trial teams are a lot like your own healthcare team. They include doctors, nurses, and other healthcare providers. They meet all required medical and ethical standards. And they often specialize in the health condition or disease being studied. Their role is to provide you with the best healthcare possible in the trial.
Watch the video to learn more about trial teams.
FICTION: You won’t be told what’s going to happen in a trial.
FACT: Before you join a trial, you will be told what to expect. You’ll be given an informed consent form with all the details. And the trial team will make sure you fully understand the trial. Their job is to empower you to make a choice. Only you can decide what is right for you.
Watch the video to learn more about trial activities.
FICTION: You can’t leave a trial if your health gets worse.
FACT: Being in a clinical trial is voluntary. You can stop participating at any time, for any reason. If your health gets worse while you’re in a trial, the trial team will talk with you about your options. But you don’t have to stay in the trial if that is not what’s right for you.
Watch the video to learn more about trial participation.
What should I learn next?
How is safety planned and monitored?
Discover how clinical trials are designed with safety in mind from start to finish.
How do clinical trials work?
Learn how clinical trials are set up, how they work, and understand the different types of trials.
Find a clinical trial
Our TrialFinder site makes it easy to search for clinical trials based on your condition and location.
Call us for help
Our navigators can answer your questions and help you use our trial finder.
1-855-329-5969
Find resources
Explore our clinical trials resource library for materials you can use to talk about clinical trials.