Clinical Trial Participation

Clinical trials are medical studies that pose a question: Does a new treatment work better than older treatments? Each year, thousands of treatments are tested in controlled experiments called clinical trials. These trials test new drugs, devices, behavior changes, surgical techniques, and more.^1,2

Here are some things you need to know before joining a study.

The pros and cons of medical studies

Taking part in a clinical trial carries many possible benefits and risks. The risks are that the treatment is experimental. This does not necessarily mean it is dangerous. It does mean this drug, device, surgery, or other treatment is new. Doctors are holding a clinical trial to learn more about this new treatment’s safety and how well it works. They may not know all of the side effects and dangers yet.

Another risk is that you may receive a placebo or older treatment rather than the new treatment, depending on the type of study. The new treatment may not work as you or the doctors thought it would. Finally, some costs tied to participating may not be covered or your health insurance may not support the cost of the trial.

The benefits to participating in a medical study are also complex. You may gain access to a new treatment that is unavailable to the public. If the new treatment works as the doctors hope it will, you may have a better outcome than people getting older treatments.

People who join clinical trials often receive thousands of dollars in free care in exchange for their participation. You may receive better care than normal because you are so closely monitored while in a study. Also, people in clinical trials help expand medical science and help improve the lives of people who come after them.^1,2

Who can join a clinical trial?

Each clinical trial has certain qualifications for who can participate. These are called eligibility criteria and may include things like:^1,2

• Diagnosis
• Age
• Gender
• Tests results
• Whether you use or have used certain medicines
• Other medical conditions
• Disease severity

For example, a trial to test a new prostate cancer drug would need the people in the trial to be males who have prostate cancer. Most trials require people to be at least 18 years old. Few trials are conducted on children and teenagers. Some trials only want healthy participants.

How does a medical study work?

Clinical trials follow a plan, which you may hear called a protocol. This plan is designed to help the doctors get consistent results that can be measured. Protocols also protect the people who volunteer by balancing the benefits with the risks of a trial. The protocol will include:^1,2

• Reasons for the study
• Goals of the study
• Who is eligible to join
• The number of people needed for the study
• The schedule of tests, procedures, or drugs and their dosages
• How long the study will last
• Information to be gathered
• Protections for people who join

All of this information will be discussed before you join a study and included in the informed consent form.

What is informed consent?

Anyone who is interested in joining a clinical trial will be given detailed information about the study before signing up. This is called informed consent, and it is required by law. Informed consent is both a process and a document. It is designed to make sure anyone who joins a clinical trial understands the potential benefits and risks of trying whatever is being tested.

Informed consent includes a discussion with your doctor and written information you can take home and read. This information will include details such as:^1,2

• What the treatment is
• Any potential benefits and risks
• How long treatment will last
• What tests and treatments are free to you for being a part of the trial
• How often you will need to report to the hospital or clinic
• Whether you will be reimbursed for expenses like travel to and from the site
• Who to contact if you have any questions or side effects to report

Before joining a study, you must sign an informed consent document. This document is not a contract. Everyone has the right to leave a study at any time. People drop out of clinical trials all the time, for a variety of reasons.

Who oversees clinical studies?

All studies of a new drug, device, surgery, or other treatment are approved and overseen by what is called an institutional review board (IRB). This oversight is required if a study receives federal funding, but many studies do this regardless.

An IRB may include doctors, scientists, and community members. These people are responsible for making sure each study is managed in an ethical manner and that the rights and best interests of people in the study are protected.

Each study will also have a principal investigator. The principal investigator is responsible for the accuracy and ethical standards of the entire study. Several government agencies also have the authority to decide whether a clinical study is correctly protecting the people in a study.