Dispelling Myths about Clinical Research

Mental health clinical research is a particularly challenging area within research. Despite the many advances, mental health research has suffered from a negative perception and the disparity between mental health research and other disease research is vast.

That’s why we all need to fight to dispel the myths around mental health clinical research. Not only is it safe and an available option for those living with mental health illnesses, research is the only way to find better treatment options and the only way we can ever find a cure.

Myth: Being in a clinical trial does not benefit the volunteer.

Fact: Being in a clinical trial may improve your medical condition. At the very least, you will receive medical care from professionals that have expertise in mental health conditions.  As a participant in a clinical research trial, you will play an active role in your own health care; you may also get extra tests, lab work, and monitoring that you might not otherwise have, as well as having the opportunity to receive a drug that would not otherwise be available to you.

Clinical research participants play a key role in helping scientists find new treatment options that will improve the lives of others living with mental health illnesses.

Myth: If I join a clinical trial, I won't get the same level of care that I receive with my doctor.

Fact: The care people get in a clinical trial is usually excellent. People in trials often say that the trial doctor and staff watch them more closely than their own doctor or nurse does during a regular office visit. This is because trials have very detailed procedures and often include extra tests and extra visits.

Myth: If I join a clinical trial, I might get a sugar pill or placebo instead of a real drug.

Fact: There are strict guidelines around the use of placebos in clinical trials. There must be a demonstrated positive risk-benefit analysis, and the participant volunteers must be fully informed of the risks involved in the assignment to the placebo group.

Not all clinical trials use placebos. The decision about whether to use a placebo in a clinical trial is based on many factors, but if a study is using a placebo, it does not mean that you will not get any sort of treatment when you enroll in the study. You usually will get an active drug. But you may or may not get the novel agent. We still strongly encourage people to enroll in one of these clinical trials, because they say that drug development takes 10 years or so to bring one drug from Phase I to Phase II to Phase III and to the clinic. So if you enroll in the clinical trial, you can help fast-forward that process.

Myth: Clinical trial volunteers need to sign an informed consent form that doesn’t let them stop before the trial is over.

Fact: The purpose of informed consent is to protect the rights of people taking part in clinical trials. It tells you all about the trial, including activities, visits, and potential risks and benefits. You may leave the trial at any time, but should always let the clinical trial team know first, because some medicines should not be stopped without the doctor’s help.

Myth: Clinical trials are dangerous because they use new practices and medicines.

Fact: Keeping trial volunteers safe is the top priority. All clinical trials are reviewed before they start by the Food and Drug Administration (FDA) and an institutional review board (IRB), made up of doctors, scientists, and community members, whose main purpose is to decide if the trial is safe to do. The health and well-being of those that participate in clinical trials is closely monitored and the trial treatments have gone through a rigorous testing process before being given to people.

Myth: Being in a clinical trial costs a lot and isn't covered by insurance.

Fact: Although most studies don’t incur any costs to the volunteer, many insurance companies do pay for any costs that may not be covered.  Trial volunteers rarely have to pay any costs at all for participation and are, in fact, sometimes paid back for expenses such as time, transportation, and parking.

Myth: If there is a clinical trial that could help me, my doctor will tell me about it.

Fact: Your doctor may not know about all available clinical trials.  You can search www.clinicaltrials.gov, the online database that you can use to find appropriate trials by zip code or medical condition.

Mental health research
is critical to the understanding and treatment of mental illnesses.

In just the past five years, research has come a long way in transforming the understanding and treatment of mental illnesses. In genetics, hundreds of places in the genome have been linked to mental illnesses, such as schizophrenia, autism, and depression. In basic neuroscience, the development of new tools and resources have dramatically increased our ability to study the complexities of the living brain. In translational sciences, the FDA has approved two of the first truly novel antidepressants in decades — esketamine for treatment-resistant depression, and brexanolone for postpartum depression.

We still have a long way to go to find better treatment options for those living with mental health conditions. 

And without clinical research,
we can’t get there.