Pre-enrollment Information

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What questions should be asked about a clinical trial?

The following questions might be helpful in discussing a clinical trial with a health care provider (Adapted from the NIH booklet What Are Clinical Trials All About?).

• What is the purpose of the trial?
• What kind of tests and treatments are involved?
• What is likely to happen in my case with, or without, this new research treatment?
• What are alternative treatment options, and their advantages and disadvantages?
• How might this trial affect my daily life?
• What side effects might I expect from the study?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• If I were harmed as a result of the trial, what treatment would I be entitled to?
• What type of long-term follow-up care is part of this study?

Related links

Questions to Ask Your Doctor

What is informed consent?

Before enrolling in a clinical trial, the doctors and nurses will discuss with all potential participants the possible risks and benefits involved. These issues are summarized in a lengthy form that explains the trial procedures and the possible side effects. This is called an informed consent form and all clinical trial participants are asked to read, understand, and sign it before beginning treatment. It is important to ask the doctor or nurse to explain any part of the form that is unclear.

Related links

A Guide to Understanding Informed Consent

An Informed Consent Template

FDA Guide to Informed Consent

The Informed Consent Process

What are eligibility criteria (inclusion and exclusion criteria)?

Participants in a study must have certain characteristics outlined in the protocol called eligibility criteria (inclusion and exclusion criteria). These criteria are different in different trials and they may include such characteristics as gender, age, health problems, and previous or current treatments. These criteria help to serve two important purposes. Firstly they aim to protect participants in the study, excluding those who are likely to be harmed by the study drugs or other treatments involved in the research. These criteria are also important in producing scientifically reliable results. For example, the treatment being studied may be effective for one type of a disease but not another, or may be more effective in women than men.

Related links

Taking Part in a Clinical Trial

Can clinical trial participants leave a trial?

Yes, trial participants can leave the trial at any time for any reason. If you choose to leave the study, you will have the chance to discuss other treatments and care with your own doctor or a doctor from the study.

The content on this page was written by Dr. Marc Engelsgjerd and Michael D'Agostino of Veritas Medicine