Without clinical trials, we wouldn’t have scientifically-tested treatments to alleviate mental suffering. They provide a well thought‑out, organized plan for testing a drug or treatment’s effectiveness and safety.
Clinical trials, sometimes called clinical studies, clinical research, or research studies, are designed to answer specific questions about health. Clinical trials are often conducted to see how well an investigational drug (the drug being tested) works to treat a specific condition.
Clinical trial participation is very different from visiting your regular doctor. When you see your regular doctor, your doctor may prescribe an already approved drug to help with a condition. When you participate in a clinical trial, you are actively participating in the drug approval process by helping scientists to see if a new treatment works or doesn’t work. As a result, you will have unique responsibilities and will be closely monitored by the research doctor.
Participation is always voluntary. You’re free to leave a trial at any time, even after it begins. You do not need to give a reason for leaving.
Before participating in a clinical trial, you will be involved in the informed consent process. During this process the risks and benefits of participating in the trial will be shared with you, and you will have the opportunity to ask any questions. Informed consent is designed to provide you with information so that you can make an informed decision about your participation in the trial.
You will receive an informed consent document outlining many of the risks and benefits of study participation. You can take as much time as you need to read and think about the informed consent document. You can even take the document home. If you decide to participate in the study, you will need to read and sign the informed consent document to do so.
Clinical trials are experimental in nature, so the risks and benefits can be difficult to predict. However, researchers will only move forward with studies that they believe might be beneficial to the participant, with acceptable risks.
All research studies have guidelines about who can participate. These rules are usually outlined in the inclusion and exclusion criteria. Things that are required for someone to participate are called inclusion criteria, while things that disqualify someone from participating are called exclusion criteria. Inclusion and exclusion criteria usually include things like: having the condition being studied, medical history, medication usage, age, and other things.
Inclusion and exclusion criteria help to identify the people most appropriate to participate in the clinical trial. Researchers use inclusion and exclusion criteria to restrict certain people from participating in a study. For example, the inclusion and exclusion criteria may restrict pregnant women from participating because their safety may be at greater risk. The criteria can also be used to restrict people from participating who aren’t in the group of people being studied in the trial. For example, the inclusion and exclusion criteria for a type 2 diabetes trial may prevent people with type 1 diabetes from participating.
Clinical trials generally provide study medication and medical care at no cost to the participant. They also often cover any study‑related costs like parking, and generally do not bill your insurance. However, each trial is different. The study team will discuss any costs or compensation with you.
The “gold standard” in clinical trials is a “randomized, placebo‑controlled” clinical trial. This means that participants are randomly assigned to either a test group receiving the investigational treatment or a control group receiving a placebo.
“Investigational” means that while the treatment has been permitted for research purposes, it has not yet been approved by the Food and Drug Administration (FDA).
A placebo is not a treatment but looks exactly like the investigational drug or treatment. Sometimes a placebo is referred to as a “sugar” pill, but the actual ingredients can vary. If the trial involves a placebo, you will be told what is in it. In trials that have an investigational treatment and a placebo, study participants do not get to choose which one they receive. It is often random, like flipping a coin.
You will learn whether the trial you’re considering involves a placebo, as well as your chance of receiving the placebo.
According to a 2017 Center for Information and Study on Clinical Research Participation (CISCRP) survey, most clinical trial participants (94%) would participate again. CISCRP is a non‑profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP conducts various surveys regarding participants’ experiences in clinical trials.
You may want to ask these, or any other, questions about the research site.
Here are some questions about the study’s potential treatment that you may want to ask.
Questions about the trial’s design and logistics may be something you want to consider.