• You are here:
• Home
•  »  Research
•  »  Clinical Trials
•  »  Participating In a Clinical Trial

Print Page

Tell a Friend

Participating In a Clinical Trial: What You Should Know

There are many reasons to participate in a clinical trial, and the decision varies with each individual.  Some participants want to contribute directly to the search for better treatments and a cure.   Others want to gain access to new research treatments before they are widely available.  And there are those who want to play a more active role in their own health care or that of their child. 

Whatever your reasons, you’re sure to have many questions—about the therapy being tested, the exams you’ll need to take, the demands on your time, safety issues, and more.  You may not even know how to find out which studies are being conducted in your community.  Here, we’ll help you find the answers to your questions.

How do I find current clinical trials?
There are several resources for finding a clinical trial.  The newest trials for food allergy can be found in the clinical trials section of FAI’s website.  Your doctor may also know about ongoing studies in your area.  Several other Web sites, such as www.clinicaltrials.gov, sponsored by the National Institutes of Health, list current trials. You can find additional useful links in our Resources section.

How do I know if I (or my child) am eligible to participate in a clinical trial?
All clinical trials have guidelines about who can participate.  Known as criteria, these guidelines are used to identify appropriate participants and keep them safe. Inclusion criteria are the factors that qualify volunteers to participate; exclusion criteria disqualify volunteers from the study. The criteria are based on such factors as age, gender, the type and stage of a disease or condition, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study by meeting the inclusion criteria.  Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.

How will I know exactly what the study will involve?
Since clinical trials are federally regulated, there are safeguards that protect participants and ensure confidentiality.

Informed consent is key to understanding and deciding to participate in a specific study.  This process enables potential volunteers to learn the facts about the study before making this important decision.  Informed consent is also a continuing process, designed to help volunteers understand what is happening as the trial progresses.

To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.  Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts.  The informed consent document explains the trial’s benefits (for example, the possibility of receiving the treatment after the trial is over, if it proves successful) and risks (such as potential side effects).  If you decide to participate, then you sign the document. It is important to remember that informed consent is not a contract—you may withdraw from a clinical trial at any time.

Questions to Ask the Research Team
If you are considering participating in a clinical trial, you should talk about it with your doctor and other members of your healthcare team.  The more you know, the more comfortable you will feel with your decision to participate.  Before you meet with the research team, you may want to write down your questions and bring a friend or relative along with you.   Here is a list of questions that you may find helpful.  

• How long will the trial last?
• Where is the trial being conducted?
• What treatments will be used and how?
• What is the main purpose of the trial?
• How will patient safety be monitored?
• Are there any risks involved?
• What are the possible benefits?
• What are the alternative treatments besides the one being tested in the trial?
• Who is sponsoring the trial?
• Do I have to pay for any part of the trial?
• What happens if I am harmed by the trial?
• Can I opt to remain on this treatment, even after termination of the trial?
• Who is going to be in the study?
• Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
• What kinds of tests and experimental treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial 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?
• Who will be in charge of my care?

A Word about Pediatric Trials
For a long time, clinical trials were conducted only in adults.   A common approach to giving children medication or other therapies has been to use data from adults and adjust the dose according to a child's weight.  However, experience has shown that new treatments do need to be studied in children.  Children are not small adults: Many different factors affect the way they respond to treatments, including the growth and maturation of their organs, changes in metabolism throughout infancy and childhood, changes in body proportion, and other developmental changes that affect how drugs are used in the body.  With this understanding, the FDA has enacted legislation that requires that new treatments be tested in children.  As a result, more studies have been conducted in children in the last five years than in the previous 30 years.

This means that, as a parent, you can have confidence that stringent guidelines apply to children’s participation in a clinical trial.  For more information on clinical trials and children, visit http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php.