Find Out if You Are Eligible to Participate

A clinical trial is a type of research study to see how a treatment affects someone’s health.

Clinical trials can study:

• New medications or new mixtures of medications
• New ways of doing surgery
• New medical devices
• New ways to use current treatments
• New ways to change behaviors to improve health
• New ways to improve the lives of people with illnesses
• Studies that compare different methods of clinical treatment prescribed by your doctor

People with and without illnesses can take part in clinical trials. Many healthy volunteers say they take part in a clinical trials to help others and to help move science forward. People with an illness may also take part to help others, and may also benefit by having access to the newest available treatments and extra care and attention from the research study team.

While there may be a lot of similarities between participating in a clinical trial and your medical care, the biggest difference is that medical care is meant to help you by using treatments that have already been tested and shown to work. Clinical trials are meant to help researchers learn more about new conditions and possibly help others in the future.

Participation in a clinical trial is not meant to replace your normal medical care -- it is still important to visit your doctors as normal while taking part in a clinical trial. Depending on the study, participating in a clinical trial may or may not be of direct benefit to you.

If you choose to be involved in a clinical trial, there may be a new group of people working with you as part of your study team. Your study team may include one or more of the following persons:

Principal Investigator (PI): The principal investigator is the person who leads the clinical trial. Their job is to ensure that everyone working or participating in the study knows what the study is about and is responsible of all aspects of the study.

Investigator: An investigator for a clinical trial may have a variety of jobs including seeing patients, working in the laboratory and, if necessary, standing in for the Principal Investigator if not available.  

Study Coordinator: Study coordinators handle the daily tasks of a clinical trial. They work closely with both study participants and investigators, doing things like finding interested participants, explaining the study to interested participants, determining if interested participants are a right fit for the study, collecting and keeping track of data, and more. 

Research Nurse: Research nurses hold an active nursing license and may have some of the same jobs as a study coordinator. In addition to these jobs, they may also perform tasks such as drawing blood, giving medications, or performing medical exams.

Clinical trials follow a plan known as a study protocol. The study protocol is a document that explains how a study will be done, the goals of the study, who can be in the study, more information about tests, procedures, and treatments, and how long the study will last. This document is important to making sure the trial participants are safe and the information collected is correct.

Inclusion and exclusion criteria are rules that tell the study team who can and who cannot join a particular study. These rules are based on things such as age and other characteristics. 

If you would like to take part in a clinical trial, you will meet with somebody from the study team to learn more about the study. This is part of the informed consent process. You will learn details about the study, the reason it is being done and how long it will likely last.  You will also discuss any tests or procedures that will be done as part of the study, possible risks and benefits of taking part in the study, and any other information about the study that will be important for you to know.

To show that you understood what was discussed and that you agree to take part in the study, you will be asked to sign a consent form. If you change your mind about taking part in the study, you can remove your consent at any time throughout the study process even after signing this form. 

In clinical trials that compare a new treatment or therapy with another that is already being used, researchers try to figure out if the new treatment is as good as or better than the existing one. In some studies, you may be picked to get either a placebo, an existing treatment or a study treatment. 

A placebo is usually a medication that looks like the study medication, but doesn’t contain any active ingredient.  Comparing a new product with a placebo can be the fastest and safest way to show that the new treatment works. Placebos are not used if it would be unsafe for you to skip the known treatment already approved for your condition. You will be told if placebos are used in the study during the informed consent process.

Randomization is the process of deciding which treatment group you will be in. This choice is done by chance, like the flip of a coin. It is done this way to avoid any bias in deciding which volunteers get one treatment over another. The results of each treatment are compared at timepoints during the trial. If one treatment is found to be better than the other, the trial is stopped so that the volunteers may get the more helpful treatment.

Blinded studies are planned so that the research team and study participants can’t affect the results of the study. This is important so that the information gathered from the study will be correct. In single-blind studies, you are not told what treatment is being given to you, but the research team knows. In a double-blind study, neither you nor the research team are told what treatment you are being given. If it is necessary for your health and safety to know which treatment you are being given, it is always possible to find out.