9 common misconceptions about clinical trial participation
At Antidote, our mission is to connect patients with clinical research opportunities. But one phrase we hear often from patients goes something like this: "Medical research is great, but it's not for me."
Of course, participating in a clinical trial is a serious decision. But, while it's important to carefully weigh the pros and cons of taking part, it's also critical to make your decision based on accurate information.
We unpack nine of the most common misconceptions around clinical trials – and the reality behind them – to help you make a well-informed decision when considering your trial options.
9 common misconceptions about clinical trial participation
Belief: I'll be treated like a guinea pig.
Reality: Many patients are concerned that if they join a clinical trial, they won't be treated with respect as a patient — just as the subject in a trial of an untested medication or device.
In reality, researchers must take several steps to ensure that patients know exactly what a clinical trial will involve before joining. This process is called informed consent, and patients can't join a trial before having the trial thoroughly explained, asking any questions they may have, and signing a form. Patients are also welcome to leave a trial at any time for any reason.
In addition, one benefit patients share about clinical trial participation is the opportunity to learn more about their condition and receive personal care from a specialist in their condition. Rather than feeling like a guinea pig, many research participants feel like they're part of the research process.
Belief: Clinical trials are dangerous because they use untested drugs.
Reality: There is a level of risk associated with any clinical trial. As part of the informed consent process, the study team must explain the specific risks associated with the clinical trial so patients can weigh their options.
Whether or not the drug has been tested in people before depends on the phase of the clinical trial. Before a potential new treatment reaches patients, it's first tested in a lab.
Phase 1 clinical trials are the first phase of human testing trials. These trials typically enroll approximately 20 to 100 healthy volunteers and only test for safety. This trial phase can last anywhere from several months to a year.
Phase II clinical trials enroll patients with the condition and test for both safety and effectiveness in treating symptoms, based on the goal of the trial. Trials in this stage can last from several months to a few years, and recruit up to several hundred patients with the condition to take part.
Phase III trials enroll several hundred to several thousand volunteers, and also last the longest. In fact, this testing phase can last several years as the FDA gathers thorough data about the drug's effectiveness and potential side effects.
Knowing the phase of the clinical trial you're interested in can let you know around how many people have already tried the drug. In the informed consent process, you'll hear about the side effects patients experienced in previous trials, and you can also ask any questions you have about safety.
Belief: Once I join a trial, I can't change my mind.
Reality: Even after signing an informed consent form, patients are still free to leave a clinical trial at any time, for any reason. When withdrawing from the trial, volunteers should let the research team know.
Belief: I don't want to join a trial because I'm afraid of getting a placebo.
Reality: Some clinical trials measure the effectiveness of a potential new treatment against a placebo, but not all trials use one. Some trials test a potential new treatment against the existing standard of care.
In some trials, if the treatment is working, it's offered to all participants during the trial.
It's important to ask whether or not a placebo is being used. Patients who receive the placebo are very important to research, but it's always understandable if you consider the risks and benefits and decide a trial isn't right for you.
Belief: Joining a clinical trial helps people in the future, but it doesn't help me today.
Reality: The clinical trial process takes several years, and if a treatment isn't effective for a patient, it may feel like you're only paying it forward. However, in addition to helping research and accessing potential treatments before they reach the market, clinical trial participants also report receiving quality, personalized care during the trial and learning a lot about their condition.
Belief: Being in a clinical trial is expensive and isn't covered by insurance.
Reality: Clinical trial participants rarely have to pay for costs related to participating in a trial. Research costs are covered by the drug sponsor. As for care costs, such as doctor's visits and lab tests, those are covered by many health insurance carriers, but you should talk with your trial team and your health insurance carrier to understand the specific coverage they offer for clinical trial participants.
Belief: I don't have time to participate in a clinical trial.
Reality: The time commitment for participating in a clinical trial varies widely. Some trials may only require a few visits every couple of months, while others may require weekly visits. Some trials offer transportation services, such as paying for cabs, public transportation, or gas, to help make it easier to get to trial visits. Some trials require overnight visits, or for a caregiver or partner to accompany patients to visits. Before signing up for a trial, you'll learn all about the trial schedule and ask any questions or share concerns you have about the schedule.
Belief: You need to live near a major hospital to participate in a clinical trial.
Reality: In addition to major hospitals and academic research facilities, regional hospitals and smaller clinics also run clinical trials. Some clinical trials offer compensation for patients who are traveling from farther distances to participate, particularly for patients participating in rare disease clinical trials. One upshot of the COVID-19 pandemic is that many clinical trials have incorporated virtual elements into their research plans. There is an increasing number of virtual (or partially virtual) clinical trials that allow participants to attend site visits over a webcam or through an app, and get blood drawn by a mobile phlebotomist.
Belief: Clinical trials are only a last resort.
Reality: Clinical trials can offer an option for patients who have exhausted other options. But there are also clinical trials available for patients at all different stages of their diagnosis. Some clinical trials look specifically for patients who are newly diagnosed, while others look for patients who experience particular symptoms and may have been diagnosed for many years.
Without volunteers, new medications can’t be approved by the FDA, and therefore can’t reach patients. Clinical trials play a major role in the advancement of scientific research and will hopefully benefit future generations. Research matters, so start your clinical trial search today: