A type of medical study to see if new drugs, devices, and treatments are safe and work in people. 

The people who lead a clinical trial are doctors or other people who work in medicine called investigators or principal (lead) investigators. 

The person leading the trial has a detailed description of the plan and procedures for the trial called a protocol. This plan explains how the study will be performed and how the information will be used to decide whether the treatment is safe and works in people. 

Clinical trials usually take place at hospitals and universities, and sometimes at community clinics. 

Anyone! Most studies will have specific conditions that a person will need to meet before they can join a trial called inclusion and exclusion criteria or eligibility criteria. These conditions are listed in the study protocol, which is a detailed description of the plan for the trial. The person leading the study will decide if each potential participant meets the conditions described in the protocol based on a series of medical tests that are called screening assessments. 

The informed consent form or document is a list of all of the details about the study. A person who is part of the team of individuals that support the study will review the informed consent with any person who is interested in joining the study and meets the specific conditions that are needed to participate in the study. After reviewing this information, the person who is interested may choose to discuss with their family before deciding whether to join the study. 

Inclusion and exclusion criteria are also called eligibility criteria because they are a list of conditions that describe why a person can or can not participate in a trial. These are specific requirements for people interested in joining a study. Inclusion criteria are conditions that must be met by the interested person and exclusion criteria are a list of conditions that would prevent a person from joining a study. 

Clinical trials are very safe! Before a trial can start, the plan for a trial must be reviewed and approved by a group of scientists and doctors called an Institutional Review Board (IRB). Plans for trials must also be reviewed and approved by the U.S. Food and Drug Administration (FDA). There are many laws that have been enacted by the U.S. government that make sure that trials are planned as safely and ethically as possible. There are also many groups of experts that oversee clinical trials to make sure that they are safe. 

Clinical trials are categorized into four phases or types. 

Phase 1: Phase 1 trials are the first time the treatment is used by people. A small group of healthy people are given the drug to learn about side effects and dosing (how much of the treatment a person should take for it to work). 

Phase 2: Phase 2 trials start after Phase 1 trials. The people that take part in these trials have the disease or condition that is being studied. Phase 2 studies see if the new treatment is safe and effective.  

Phase 3: Phase 3 trials start after Phase 2 trials. These are often the last studies before the FDA decides whether a treatment should be available to everyone. In Phase 3 trials, the drug is given to a larger group of patients with the disease.  

Phase 4: Phase 4 trials are sometimes called post-market studies and are performed after the drug is available to everyone to provide more information about the drug’s safety and how well it works.  

You may receive the treatment being studied or a placebo (a treatment that does not have an effect). The investigator (the lead doctor for the clinical trial) will use chance to assign people who have joined the study to different treatment groups. Most of the time, even people that are assigned to the placebo group will still take a second treatment that is safe and works in people. Doctors will make sure that a person with the disease or condition being studied receives treatment during the clinical trial even if it is not the new treatment being studied. People who receive the placebo will often take the treatment that is most commonly provided for their disease or condition which is called the Standard of Care. 

Clinical trials lead to new treatments that help people live longer and healthier lives. Clinical trials also help us learn more about diseases and other health conditions.  

Less than 5% of all cancer patients are currently enrolled in a clinical trial. Also, the race and ethnicity of people that join clinical trials does not always match the race and ethnicity of people that most often have the diseases that are being studied in clinical trials. When there are not enough BIPOC (Black, Indigenous, People Of Color) people joining clinical trials, it is harder to see if the new treatments are safe and effective for people from these populations. People that join a clinical trial are able to receive the newest treatments and high quality care. People that join clinical trials may also be able to earn money by volunteering to take part in the study. 

Just ask! You can ask your doctor if there are any clinical trials in your area that you might be able to join. Your doctor might not be leading a clinical trial as an investigator but they may be able to help you get in contact with someone who is leading a trial or part of a study team. A study team may include doctors, nurses, study coordinators, social workers, and other people who work in health care that are working together to run a clinical trial.  

Questions you may want to ask your doctor or study team include: 

• What is the purpose of the study?
• Who can join the study?
• Where will the study be located?
• How will I know that the treatment is working?
• Who will be in charge of my care?
• Has the drug, device, or treatment been tested before?
• What kinds of tests and treatments are part of the study?
• What are the possible risks, side effects, and benefits that could happen if I joined the study?
• How do the possible risks, side effects, and benefits that could happen during the study compare with my current treatment?
• How might this clinical trial affect my daily life?
• How long will the clinical trial last?
• Who will pay for my treatment?
• Will I be reimbursed for other expenses?
• Is there additional care included after the study ends?
• Will I have access to the clinical trial results?

Joining a clinical trial is a big decision! Talking with family or other people that are important can help you make the decision on whether or not to take part in a study. Your doctor and the clinical trial study team will be able to give you the information you need to discuss a clinical trial with your family. Here is some information you may want to talk about: 

• Why do you want to join a clinical trial?
• What are the benefits and risks?
• How will you know if the treatment is working?
• What does it cost?
• What is the difference between your current treatment and the treatment being studied in the clinical trial?
• What happens if you take a placebo or are in the control group on the trial?