Steps of a Clinical Trial

In the United States, each research study is reviewed by an Institutional Review Board (IRB). An IRB is a committee of medical experts, scientists, doctors, and other representatives who carefully consider each new study before it begins. Every clinical trial has to be approved based on a careful evaluation of the potential benefits and risks. This helps protect the health and rights of patients.

Only certain patients can be included in a clinical trial. Patients are screened to see if they meet certain criteria. The specific qualifications for a study are known as eligibility criteria or inclusion criteria. The criteria are different for each study. They may include the type or stage of disease, patient age, health conditions, and other factors. Patient screening helps to protect the health and safety of patients so that only those most likely to benefit in a safe way are included in the study. This also enables scientists to learn about the impact of treatment based on the characteristics of the participants.

Participating in a research study is completely voluntary. There are many things to consider when deciding whether to enroll in a clinical trial. The process of understanding the aspects of a research study and choosing to participate is called informed consent. If the patient is not an adult or is not able to give consent, a parent or legal guardian will be asked to give written permission by signing an informed consent form. Children may also be asked to sign an assent form saying that they agree to take part in the research study. A member of the research team will explain the study so that the child and family understand and know what to expect. Younger children under age 7 are not usually asked for assent. Through the informed consent process, patients and families should feel that they have been given enough information to decide whether to participate.

Patients should understand:

• What is the purpose of the research?
• Who is eligible to participate?
• What treatments are included and how are they given?
• What tests and procedures are done and how often?
• What are the risks of treatment and procedures and how are they monitored?
• What treatments are available outside of the clinical trial?
• How does the research team communicate with patients?
• How is information shared with others or kept confidential?
• What should I do if I have questions or concerns?