Clinical research trials test new drugs, therapies and devices to find out if they are safe and effective for people to use.

It is very important that new drugs, therapies and devices are tested in children and teenagers.

Clinical research is the process that gives us safe and effective medications, therapies and medical devices
and gives us new information about medical conditions like Pedi IBD.

A clinical trial is the part of the clinical research process that tests new drugs, therapies and devices in human beings.

Clinical trials find out if new drugs, therapies and devices

• are safe and effective for human beings to use
• work or don’t work and why
• new information about medical conditions like Pedi IBD

Each clinical trial has very clear rules that let you know who can and cannot participate. The rules are called the inclusion and exclusion criteria.

Inclusion and exclusion criteria can include things like:

• whether you are a boy or girl
• how old you are,
• what medical condition you have

Different kinds of clinical trials test for different things, for example:

• Treatment trial – tests experimental treatments, new combinations of drugs and kinds of surgery
• Prevention trial – looks for better ways to prevents disease and prevent disease from returning
• Diagnostic trial – finds better tests and procedures for diagnosing a disease

A clinical trial has 4 different phases including:

• Phase 1 – tests only a small group of people, usually healthy volunteers, to determine how much of a study drug, device or therapy is safe to take and to see if there are any side effects
• Phase 2 – tests a larger group of people with the disease to see if the study drug, device or therapy does what researchers hope that it will. Also continues to look for side effects and test for safety.
• Phase 3 – tests an even larger group of people to double-check that the study drug, device or therapy works well and is safe to use. This phase still looks for side effects.
• Phase 4 – happens after the study drug, device or therapy has been approved for use and is available to the public. This phase continues to collect information about side effects and safety.

Clinical trials with children are important because children are not little adults.

Did you know that many of the medicines given to children have been tested in adults only? This is called an “off-label” use of a drug.

Clinical trials that are conducted with children help to:

• find the best dose of medicines to prevent harmful effects or under-treatment
• make tablets, liquids or chewables that are easier for children to take
• treat children like children and not as little adults

Deciding whether or not you want to take part in a clinical trial is a serious decision and is completely up to you. It is important to remember that:

• you must have your parent’s approval
• no one can force you to
• or make you feel bad if you decide not to participate

The informed assent process is about making your own decision, whether yes or no. Your medical care and treatment will not change if you decide that you do not want to be in the clinical trial.

If you do decide to be in a clinical trial, you will be asked to sign an informed assent form that tells you all about what is going to happen during the trial.

The informed assent form is not a contract.

If you give your assent and start in clinical trial and you or your parents feel you need to stop, you have every right to.

It helps if you and your parents are familiar and comfortable with the clinical trial team.

The team will always answer any questions during the whole clinical trial and not just at the beginning.

The clinical trial study team must follow an approved study protocol, or plan, which lists exactly what researchers will do in the trial and how.

Remember that because these treatments and therapies are still being tested for safety there may be side effects, sometimes long-term, that the research team may not know about at the time.

Even with efforts to make you safe, remember there may still be risks. Make sure you and your parents understand all of the possible risks and benefits to you. In the end, you and your parents must be comfortable with what you will be doing in a study.

It is also important to know who to call for general questions related to the trial and who to call in an emergency.

When you are searching for pediatric research trials for children with Pedi IBD on the internet remember to include one or all of the following keywords and phrases:

• pediatric
• IBD
• inflammatory bowel disease
• Crohn’s disease
• ulcerative colitis

The following websites list currently running research trials:

www.clinicaltrials.gov
ClinicalTrials.gov is a search engine of current research trials.

It is a free service run by the National Institutes of Health (NIH) and right now lists more than 60,000 studies in over 150 countries.

You can search by:

• disease
• drug/therapy/device
• location

Study information listed includes:

• type and phase of study
• condition being studied
• purpose of the study
• inclusion and exclusion criteria
• sponsor
• location(s)
• contact information

www.centerwatch.com
CenterWatch.com is a search engine of current research trials. It is a free service of Jobsen Medical Information, a Boston-based publishing and information service.

Centerwatch offers many of the same features listed above for ClinicalTrials.gov and also offers a free service where you can register online for the notification service and find out when a new Pediatric IBD trial is listed.