Are clinical trials safe?
Safety is the top priority in clinical trials. Clinical trials rely on participants, and nothing is more important than keeping them safe. The work to protect trial participants starts long before the first person joins a trial. And it doesn’t stop there: the safety of trial participants is a top concern throughout the trial, and even after it concludes.
Planning for safety
The healthcare professionals running a trial create special plans and rules called safeguards. Safeguards are designed to keep clinical trial participants safe. There are also authorities that monitor all clinical trials to make sure they’re as safe as possible.
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.
Doctors explain how patient care and safety come first
Clinical trial safeguards
Protocol
Before a trial starts, the sponsor develops a written plan, called a protocol. Trial teams must follow the protocol.
Informed consent
The informed consent form explains the trial to participants and loved ones. This form has details about all trial activities and known risks.
Legally authorized representative
Some people may be mentally or physically unable to provide consent. In that case, a legally authorized representative (LAR) acts on their behalf.
Health assessments
Health assessments at trial visits help the trial team monitor each participant’s health. A few examples of assessments are physical exams, blood tests, and heart tests.
Trial team oversight
Trial team oversight includes a close review of test results. This is done at the trial site. It may happen during or soon after each visit.
Safety reviews
Safety reviews are done throughout the trial. Based on the results, the sponsor can make changes to the trial to better protect participants.
External safeguards
Most people have heard of the Food and Drug Administration (FDA). But they might not know the FDA plays a key role in clinical trials.
The FDA oversees trials to:
- Protect the rights, safety, and welfare of all participants
- Ensure good clinical practice (GCP) regulations are followed
On the other hand, most people have not heard of Institutional Review Boards (IRBs). These groups include healthcare providers, scientists, and members of the community. Their role is to review a trial before it starts and while it is taking place. This ensures proper steps are taken to protect trial participants.
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?
Your clinical trial experience
If you’re thinking about joining a clinical trial, learn about the typical clinical trial journey for patients.
Who makes clinical trials happen?
It takes a lot of people and teams working together to run a clinical trial. Learn about each essential role.
Find a clinical trial
PAN’s TrialFinder site makes it easy to search for clinical trials based on your condition and location.
Call us for help
Our ComPANion Access Navigators can answer your questions and help you use our trial finder.
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