Your Participation in a Clinical Trial

You may choose to participate in a clinical study for a variety of reasons. Before you do, you should carefully consider whether the trial is right for you. Trial investigators also need to determine whether you’re eligible to participate.

Who Can Participate?

Investigators use participation guidelines to show which characteristics they are seeking in subjects. The factors that allow someone to participate are “inclusion criteria” and those that disqualify someone are called “exclusion criteria.” These may include:

  • Age
  • Gender
  • Type and stage of a disease
  • Previous treatment history
  • Other medical conditions

Guidelines for participation ensure that the results of the trial will reflect the treatment being studied, rather than outside factors. This helps researchers achieve accurate and meaningful results.

Enrolling in a Study

Participating in a clinical trial may yield significant health benefits, but there are risks involved with any experimental treatment.

If you are considering joining a study, you should educate yourself about the process, risks, and benefits. Much of this information is in the informed consent document that you will need to sign before participating.

In addition, the health care team will discuss the study with you and answer any questions you may have about the study before you make your decision about participating.

Here are some questions that might be helpful for you to ask:

  • How long will the trial last?
  • What kinds of treatments, tests, or procedures will I have during the study? How do they compare with what I would receive outside the study?
  • What is the main purpose of the trial? In what phase is the trial?
  • Why do researchers believe the treatment being tested may be effective? Has it been tested before?
  • What are the possible short- and long-term risks, side effects, and benefits to me? How do they compare with standard treatment?
  • Will I be able to see my own doctor? Who will be in charge of my care?
  • Who is sponsoring the trial?
  • Will I have to pay for any part of the trial?
  • What is my health insurance likely to cover?
  • What happens if I become sick while participating in a trial?
  • Can I choose to remain on this treatment after the trial is over?
  • How are the study data and patient safety being monitored?
  • When and where will study results and information go?