Unpacking Clinical Trial Myths and Truths
For many, the topic of clinical research can be confusing. The information available has rapidly changed over the years, and with that, so has misinformation. This blog outlines 10 common myths and truths in clinical trials.
MYTH 01
“I am essentially a guinea pig if I participate in a trial.”
This idea suggests participants will come into a clinical trial with set expectations, only to be poked and prodded by researchers with little regard for them. In reality, upon joining a clinical trial, participants will go through an informed consent process, which should outline exactly what the trial will entail and how they can expect to be treated.
Additionally, all clinical trials must go through institutional review board (IRB) review, which reviews the protocol. An IRB’s main goal is to ensure the rights, safety and welfare of participants. Between the IRB and the informed consent process, participants can rest assured that they will be taken care of properly.
MYTH 02
“I will just get the placebo if I participate in a clinical trial.”
While placebos can be used in a clinical trial, they are not always used. Typically, trials include a mix of the drug they are testing, the standard of care that’s used currently and the placebo.
However, participants should have an idea of what type of drug they may end up getting, whether that’s the study drug, standard of care or placebo. This should be outlined in the informed consent process prior to and during the trial.
MYTH 03
“Clinical trials are only for really sick people.”
There are many different types of trials available for terminally ill patients, diseases that could benefit from improved medical options and even trials where researchers just want more information about what they are studying. Regardless of who the trial is geared for, clinical trials have the ability to advance science and medicine, helping many across the globe.
MYTH 04
“Once I’m in a clinical trial, I can’t change my mind and leave it.”
Participants have free will at all times to leave a trial with no questions asked. This is in effect even after they sign an informed consent form. The consent process can also enable participants to decide whether or not they want to continue during a trial.
With any protocol change, it’s important to update the informed consent form and notify participants. This helps them stay up-to-date on the study, and further enables them to make the best educated decision for them on whether or not they want to continue.
MYTH 05
“It will cost me money to be in a clinical trial.”
Clinical trial sponsors secure funding, and because of that, trials are nearly no cost for participants. However, if there are tests and treatments that do fall on the participant, they may fall under standard of care, which could be picked up by insurance.
The informed consent process will outline what these costs should look like, along with who will cover what, so there shouldn’t be any surprises.
MYTH 06
“I don’t live near a major hospital, so there are no trial options for me.”
There are many clinical trials happening at local clinics, regional hospitals or even virtually. The goal of a clinical trial is to gather diverse data from a large participant pool, which means reaching participants from many different locations. As long as someone meets the study criteria and can either travel to a participating site or take part remotely, location doesn’t have to be a barrier.
MYTH 07
“Because a clinical trial is ‘new’, it’s dangerous to my health.”
All clinical trials go through rigorous IRB review, which means trials approved by the IRB are safe for participants.
Drugs are tested in the laboratory before making it to Phase I
Not only that, but before a trial is eligible for humans to partake in, the drug is tested in the laboratory before making it to Phase I. Then, once a drug is deemed safe, it goes through different phases, starting with a small participant pool, gradually increasing as a drug moves through the phases. Throughout the entire trial process, participant safety is kept at the forefront to ensure all participants are protected.
MYTH 08
“Anyone who wants to participate in a clinical trial simply can.”
There are inclusion and exclusion criteria associated with every single clinical trial, which are parameters for who can or cannot qualify for a clinical trial. Factors such as age or health status are all criteria researchers are looking for as they are setting the inclusion and exclusion criteria.
So, while everyone who wants to participate in a clinical trial may not actually be able to, if someone meets the criteria and wants to participate, they likely can.
MYTH 09
“I can’t participate in that trial because my doctor didn’t refer me.”
While some participants are referred to a clinical trial, more often than not, they aren’t. It’s more likely a participant will find a clinical trial they’re eligible for than a doctor recommending them for one.
However, it doesn’t hurt for participants to ask if there are any clinical trials relevant to them and their health condition – doctors either may know of some, or may know which direction to point participants in to find themselves. From there, if a person meets the inclusion and exclusion criteria, they can be eligible for the trial, no matter how they found it.
MYTH 10
“I won’t get the same level of care in a trial than I do from my doctor.”
Research teams are incredibly dedicated to the clinical trial, and this includes caring for the participants involved. Oftentimes, trials necessitate frequent appointments and check-ins with study staff. From this perspective, participants may end up getting more care than from their primary care doctors.
As is a common theme throughout all of these myths, it’s essential for trial participants to have initial and ongoing conversations with research teams. Not only does that help clear up any misconceptions about clinical trials, it also gives participants a clear idea about what to expect while they are a part of the trial.
Trust Sabai Across All Research Phases and Therapeutic Areas
As a central IRB and institutional biosafety committee (IBC), Sabai is uniquely qualified to help bust any myths surrounding clinical trials. We support sponsors and sites across all phases of research and all therapeutic areas. We are ready to help you advance your research goals.