How to Participate in Clinical Trials

Participating in a Clinical Trial

If you have been diagnosed with a serious illness or other medical condition and are looking for a way to take an active role in your treatment, or you are interested in helping advance medical research, then participating in a clinical trial may be an option for you. Clinical trial participants often have access to potential new treatments before they are available to the general public, including investigational treatments for some diseases that currently have no treatment options. In addition, the medical care that participants receive in a clinical trial follows a strict protocol that has been designed with patient health and safety as a top priority, and trials are carefully monitored by trial sponsors and health authorities to ensure that participants receive quality care. Clinical trial participants also help researchers learn more about how new treatments work. Their commitment contributes to a growing body of knowledge and helps elevate the standard care for disease. There are different types of clinical trials, and not everyone is eligible to join a trial. Before you consider taking part in a trial, here are some things to consider that might help you make an informed decision.

1) What are the available options?

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 and can discuss the benefits and risks with you to help you decide if a trial might be worth considering. You can learn about ongoing Astellas studies by visiting clinicaltrials.astellas.com. You can also learn about ongoing studies for other sponsors online at web sites such as ClinicalTrials.gov. This site, which is maintained by the U.S. National Library of Medicine at the National Institutes of Health, contains information about clinical trials for a wide range of diseases and conditions. Clinical trials included in ClinicalTrials.gov span all 50 states in the U.S. and 220 countries worldwide. You can search for trials being conducted for a specific disease or condition, trials evaluating a specific drug or medical device, or trials that might be close to where you live. Here are some other web sites that offer information about clinical trials:

• National Institutes of Health Clinical Center
• HealthyChildren.org
• Cancer.gov
• fda.gov
• Center for Information and Study on Clinical Research Participation
• CenterWatch

2) What is the study about?

If you find a study that you might want to join, read a summary of the study. Learn about the trial’s main objectives. Discuss these with your doctor, who can help you understand the study procedures, the intervention being studied, and whether you might be eligible to participate.

3) Who can participate?

Not everyone can join a clinical study. Each clinical trial has a list of eligibility criteria that determine who can and cannot take part. For example, trials that are designed to evaluate the effect of a drug on a specific disease or medical condition often only enroll people who have a confirmed diagnosis of that disease or condition. Eligibility criteria also exclude participants with certain medical conditions if these would make it unsafe for them to take part.

4) How can I sign up?

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

5) Learn about the informed consent process.

The National Institutes of Health defines “informed consent” as the process by which a volunteer confirms his or her willingness to participate in the research after having been informed of all aspects of the trial that are relevant to the volunteer’s decision to participate. This is documented by means of a written, signed, and dated informed consent form. A study doctor or research nurse will discuss the details of the trial with you, such as the treatments you might receive, the eligibility requirements, what would be expected of you as a participant, the schedule of trial site visits, the laboratory tests that will be done at each visit, what you might need to do on your own at home, and the potential risks associated with joining the trial. If you decide you want to join, you will be asked to sign the informed consent form to confirm that you understand all of these details.

6) Do I have to pay for my participation?

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

7) What if I change my mind?

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

Clinical Trial Participation: What to Expect

There is an element of uncertainty in clinical trials, particularly in clinical trials that are evaluating new treatments. However, clinical trials are carefully designed by researchers and monitored by the trial sponsor, by health authorities such as the Food and Drug Administration in the United States, and by dedicated committees that safeguard participant rights and safety. 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 your participation.

Types of Clinical Research Participants

There are two main types of research participants:

• Healthy volunteers. Early-stage clinical trials for new treatments often enroll small groups of healthy volunteers. These trials are designed to assess the safety of an intervention and learn more about how it behaves in the body before it is given to a larger group 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.
• The second and the more common type of clinical trial includes participants who are patients—people who have the medical condition being studied.