Halloween is the season for haunted houses, creepy costumes and stories that make you leave the hall light on. Clinical research shouldn't be one of those stories. Still, a lot of people feel uneasy about it, and most of that unease comes from clinical trial myths that have been floating around for years.
If you've ever wondered "are clinical trials safe?" or "what actually happens if I join one?", you're asking exactly the right questions. Below, we've pulled six of the most common myths out of the shadows and paired each one with what's really true, using information from the U.S. Food and Drug Administration (FDA) and the Center for Information and Study on Clinical Research Participation (CISCRP).
Myth 1: The Guinea Pig Ghost Story (So, Are Clinical Trials Safe?)
The myth: "You're just a guinea pig."
The truth: Every clinical trial has an informed consent document. It explains the purpose of the study, every visit and activity you'd be asked to do, and the possible risks and benefits, so you have the full picture before you decide anything [2]. The study team walks you through this as part of an informed consent process before you agree to join [1].
Studies are also checked before they ever begin. Clinical trials are reviewed by the FDA and by an institutional review board (IRB), a group of doctors, scientists and community members whose main job is to decide whether a trial is safe to do [2]. Once a study is running, researchers have to follow detailed plans and the FDA's safety requirements, and volunteers are watched closely [1][2].
No research study is risk-free, and nobody should tell you otherwise. That's exactly why the possible risks are written down and explained to you ahead of time [2].
Myth 2: The Haunted House You Can't Leave
The myth: "Once you sign up, you can't leave."
The truth: Taking part in a clinical trial is always voluntary, and you can leave a study whenever you want [1]. Signing the informed consent form doesn't lock you in. Its purpose is to protect the rights of the people taking part [2].
There's one important step if you decide to stop: tell the study team first. Some medicines shouldn't be stopped suddenly without a doctor's help, so the team can make sure you stop safely [2].
Myth 3: The Sugar Pill Trick (With No Treat)
The myth: "You'll just get a sugar pill and no real care."
The truth: Some studies do use a placebo, which is a pill that doesn't cause harm or good on its own [2]. Whether a study uses one depends on how serious the illness is, whether a treatment already exists and other ethical considerations [2]. When an effective treatment is already available, or when the illness is serious, the available treatment is usually used instead of a placebo [2].
In studies that do use a placebo, one group gets the study medicine and another group gets the placebo, so researchers can compare the two fairly [2]. Because the informed consent document lays out all of the study's activities, this is something you'll learn about before you join, and you can always ask the team to explain it in plain terms [2].
Myth 4: The "Bargain-Bin" Care Rumor
The myth: "Trial care is second-rate."
The truth: The care people receive in a clinical trial is usually excellent [2]. Many volunteers say the study doctor and staff keep a closer eye on them than they're used to at a regular office visit. That's because studies follow very detailed procedures and often include extra tests and extra visits [2].
Being in a study doesn't mean giving up your regular doctor, either. It's a good idea to keep them in the loop the whole time.
Myth 5: The Bill That Comes Back to Haunt You
The myth: "It'll cost you a fortune."
The truth: People in clinical trials rarely have to pay any trial costs [2]. Many insurance companies also cover costs that the study sponsor doesn't, especially routine care that you'd get even if you weren't in a study [2]. Some studies also pay volunteers back for expenses like travel and parking [2].
Every study is different, so this is one area where you should always ask. The study team can tell you what's covered, what isn't and whether any expenses are reimbursed before you make a decision.
Myth 6: Your Doctor Has a Crystal Ball
The myth: "My doctor would already know about every trial for me."
The truth: Your doctor may not know about every clinical trial that's available [2]. Doctors are busy, and there are a lot of studies out there.
The good news is you have options. You can talk with your health care provider about whether a study might be right for you, and you can search for studies in your area at ClinicalTrials.gov [1]. Patient advocacy groups for specific conditions can also help with the search [2]. And you can always reach out to a local research site directly and ask what they're working on.
Questions to Ask Before Joining Any Study
The informed consent process is your chance to ask anything at all before you agree to join [1][2]. If you're not sure where to start, here are some good questions to bring with you:
- What is the study testing?
- What will I be asked to do?
- How often are the visits, and how long do they take?
- What are the possible risks?
- Is there a chance I'll receive a placebo?
- Will it cost me anything? Are any expenses reimbursed?
- Who can I call if I have a question or a problem during the study?
- What happens if I want to leave?
There are no silly questions here. A good study team will be glad you asked.
Have Questions? We're Here, No Tricks
The scariest part of clinical research is usually not knowing what to expect. At Prolato Clinical Research Center in Houston, our team is happy to talk through your questions, explain how research studies work and help you decide what feels right for you, with no pressure at all.
If you're curious, you can learn more on our patient studies page. We also encourage you to talk with your own doctor about whether a research study makes sense for you [1].