How to Join a Clinical Trial

Taking part in a Clinical Trial

If you have a disease or other medical condition and are looking for a way to take an active role in your treatment, or you want to help advance medical research, then joining a clinical trial may be an option for you.

Clinical trial participants often get access to potential new treatments before they are available to the public. This includes investigational treatments for some diseases that currently have no treatment options. The medical care in a clinical trial follows a strict protocol designed to keep patients safe. Trials are closely watched by trial sponsors and health authorities to ensure quality care.

Participants also help sponsors learn more about how investigational treatments work. Their commitment contributes to a growing body of knowledge and helps improve the standard of care for various diseases and health conditions.

There are different types of clinical trials, and not everyone meets the criteria for a specific clinical trial. Before you consider taking part in a clinical trial, here are some things to consider that may help you make an informed decision.

1) What trials are available to me?

One of the best ways to learn about clinical trials is to ask your health care provider. Your doctor may have information about clinical trials in your area. They can discuss the benefits and risks with you to help you decide if a clinical trial might be worth considering.

You can learn about ongoing Astellas trials by visiting clinicaltrials.astellas.com. You can also learn about ongoing trials by other sponsors at websites such as ClinicalTrials.gov. This site, which is maintained by the U.S. National Library of Medicine at the National Institutes of Health, has information about clinical trials for a wide range of diseases and conditions. Clinical trials included in ClinicalTrials.gov span all 50 states in the United States and 220 countries worldwide. You can search for clinical trials for a specific disease or condition, trials evaluating a specific drug or medical device, or trials that might be close to where you live. You can also visit patient advocacy organization websites that provide resources about ongoing trials.

Here are some other websites that offer information about clinical trials:

• National Institutes of Health Clinical Center
• HealthyChildren.org
• National Cancer Institute
• U.S. Food and Drug Administration
• Center for Information and Study on Clinical Research Participation
• CenterWatch

2) What is the clinical trial about?

If you find a clinical trial that you might want to join, read a summary about it. Learn about the clinical trial’s main goals. Discuss these with your doctor, who can help you understand the clinical trial procedures, the intervention being studied (if there is one), and whether the clinical trial might be a good fit for you.

3) Who is the clinical trial for?

Not everyone can join a specific clinical trial. Each clinical trial has a list of criteria that determine who can and cannot take part. For example, a clinical trial might study an investigational drug for a specific form of a disease or only include people in a certain age range. Some trials exclude people with certain medical conditions if it would be unsafe for them to take part. And some trials include healthy volunteers.

There are two main types of clinical trial participants:

• Healthy volunteers. Early-stage clinical trials often enroll small groups of healthy volunteers. These trials check the safety of a treatment and learn how it behaves in the body before giving it to more people or to people with a specific disease. Some trials enroll healthy volunteers to learn more about how the human body works – about what keeps us healthy, or what makes us sick.
• Patients: The more common type of clinical trial includes people who have the medical condition being studied.

4) How can I join?

Your doctor may be able to help you enroll in a clinical trial. You may also be able to reach out to a clinical trial site directly if you find information about a clinical trial online.

5) What is informed consent?

The National Institutes of Health define informed consent as “the process of providing you with key information about a research study before you decide whether to accept the offer to take part. The process of informed consent continues throughout the study.” This is usually with a written, signed, and dated informed consent form. To help you decide whether to take part, the study doctor or other member of the research team will discuss the details of the clinical trial with you, such as:

• Treatments you might get
• Who can join
• What would be expected of you
• The schedule of trial site visits
• The lab tests that will be done
• What you might need to do on your own at home
• Potential risks

If you decide you want to join, you will sign the informed consent form to confirm that you understand all of these details.

6) Do I have to pay to take part?

Many clinical trial costs, like certain exams and tests and sometimes travel costs for participants and caregivers, are covered by the clinical trial sponsor. Your health insurance may also cover some costs. The potential costs will be discussed with you before you agree to join a clinical trial as part of the informed consent process.

7) Will I get paid to take part?

Most clinical trial participants are not paid, but healthy volunteers might be paid to take part in clinical trials that are testing the safety of an investigational treatment for the first time.

8) What if I change my mind?

Joining a clinical trial is 100% voluntary. Even after signing the informed consent form, you can choose to leave the study at any time and for any reason.

Taking Part in a Clinical Trial: What to Expect

Before you decide to join a clinical trial, a member of the clinical trial team will explain the trial to you and ask you questions about your health. You can decide together if the clinical trial is the right next step for you. This is also a good time to ask questions about what to expect during the trial.

Learn more about what to expect when deciding to take part in a clinical trial.

Find an Astellas Clinical Trial Near You

Search Astellas Clinical Trials to see if any might be a match for you or for someone you care about.