Clinical Trial Participation

Patients and Advocates

For patients, there is a lot to consider before choosing to participate in a clinical trial.  Before doing so, it helps to talk to your physician, family members, friends, or others who have participated before.  In addition, there are some other key considerations to keep in mind.

What should people consider before participating?

It’s important to know as much as possible about the clinical trial you are considering.  Ask members of the health care team questions so you can know what to expect, especially with consideration to the care provided and cost of the trial.  Here are some important questions you should consider:

  • What is the purpose and who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective?
  • Has this drug, device, or treatment been tested before?
  • What are the possible risks, side effects, and benefits involved?
  • How long will the trial last and how will it affect my daily life?
  • Will hospitalization be required?
  • Who will pay for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow-up care is part of this study?
  • How will I know that the experimental treatment is working?
  • Will results of the trials be provided to me?

Preparing for a clinical trial

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB)—an independent committee of physicians, statisticians, community advocates, and others—to minimize risks and ensure benefits outweigh those risks. Outside the U.S., these bodies are generally referred to as Ethics Committees.

Before meeting with the doctor, research team, or other members of the trial process, you should:

  • Plan ahead and write down possible questions (like those above) to ask.
  • Ask a friend or relative to come along for support.
  • Bring a tape recorder to record the discussion to replay later so you have all the facts.

Can a participant leave a clinical trial after it has begun?

Absolutely.  A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

For more information

  • The I’m In campaign is focused on increasing participation in clinical trials among traditionally underrepresented groups, such as African American, Asian American, and Hispanic populations.  Learn more.
  • The Center for Information and Study on Clinical Research Participation (CISCRP) is an independent non-profit organization that works to educate the public and patients about clinical research. Learn more

Learn more about clinical trials.