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

Clinical trials are designed to test new ideas for drugs, therapies and devices to find out:

• if they are safe and effective for human beings
• how they works or don’t work and why
• new information about medical conditions like Pedi IBD

Clinical trials can take place in hospitals, universities, doctor’s offices, and community clinics.Participants in the clinical trial, or study subjects, can include men, women and children of all ages and ethnic groups. Each clinical trial has very specific rules that determine who can and cannot participate. The rules are called the inclusion and exclusion criteria.

Inclusion and exclusion criteria can include things like

• gender
• age
• type of disease

TYPES OF CLINICAL TRIALS
Treatment trial – tests experimental treatments, new combinations of drugs and new approaches to surgery

Prevention trial – looks for better ways to prevents disease and prevent disease from returning with vaccines, vitamin/mineral supplementation and lifestyle changes

Diagnostic trial – finds better tests and procedures for diagnosing a disease

Screening trial – finds the best way to detect a specific disease

Quality of life trial – tests ways to improve the quality of life for people with, for example, chronic illnesses such as Pedi IBD

PHASES OF CLINICAL TRIALS
Phase 1 – tests only a small group of people to determine how much of a study drug, device or therapy is safe to take and to identify the side effects

Phase 2 – tests a larger group of people to see if the study drug, device or therapy does what researchers hope that it will and continue to identify side effects and test for safety

Phase 3 – tests an even larger group of people to basically double-check that the study drug, device or therapy works effectively and is safe to use. This phase continues to identify side effects and also compares to commonly used treatments or therapies

Phase 4 – are post-marketing studies conducted 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. Many medicines given to children have been tested in adults only. This is called an “off-label” use of a drug.  Most of the time, this way of prescribing a medication is fine but because children are not only smaller in size but also are developing and growing, off-label use can sometime be ineffective or even harmful.

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
• find treatments for certain diseases or conditions that occur in both children and adults but which act differently in children and adults
• understand how medicines are used in and filtered out of the body in children of all ages
• treat children like children and not as little adults

RISKS
There are risks to clinical trials.

• There can be unpleasant, serious or even life-threatening side effects with an experimental drug/therapy/device
• The experimental treatment may not work for your child
• The protocol can require more time and attention than would a non-protocol treatment

BENEFITS

Clinical trials allow you and your child to:

• play an active role in your child’s health care
• have access to new research treatments before they are available to the public
• get expert medical care at leading health care facilities during the trial
• help others by contributing to medical research

SIDE EFFECTS AND ADVERSE REACTIONS
Side effects are any unwanted effects of the experimental drug, therapy or device. Negative, unpleasant or adverse effects can include things like:

• headache
• nausea
• hair loss
• skin irritation

You and your child will be told about all of the known side effects that can happen when participating in the clinical trial. 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.

Clinical research trial subjects, or parents and children who agree to take part in a clinical trial, are protected by

• ethical and legal codes
• federal regulations
• built in safeguards

You must give your written consent before your child’s participation in the clinical trial can begin. In some cases, your child will also have to give his or her own separate consent, or assent, as well.

The process of informed consent lets you and your child know exactly what is going to happen during the trial including information like how long the trial will last, how many visits will be involved, what kind of procedures and testing will take place. The study team will answer any questions before you give your consent and begin the clinical trial.

As a parent, you must be comfortable with what your child will be doing in a study.  Even with efforts to make your child safe, remember there may still be risks. Make sure you understand the possible risks and benefits and understand how they apply to your child.

PROCESS OF INFORMED CONSENT AND ASSENT
Deciding to allow your child to participate in a clinical trial is completely up to you. No one can force you to or make you feel bad if you decide not to participate.

The informed consent process is about making your own decision, whether yes or no. Every parent has to make the individual decision and consider what is right for their child and their family. Your child’s medical care and treatment will not change should you decide that you do not want your child to participate in the clinical trial.

The informed consent form is not a contract. If you give your consent and your child is enrolled in a clinical trial and you feel you need to leave, you have every right to do so. You may leave the study at any time, for any reason. And again, your child’s medical care and treatment will not change because you choose to withdraw your child from the clinical trial.

Informed consent is the process of:

• learning the important facts about a clinical trial
• deciding whether or not your child will participate

This process continues throughout the clinical trial, providing ongoing information about the trial to you and your child.

The Informed Consent Form lets you know:

• what the researcher is trying to find out in the clinical trial
• what you and your child will be asked to do during the trial
• how long the trial will last
• possible risks to your child
• possible benefits to your child
• who to contact from the clinical trial team if you have questions

Remember to read the entire form, even though some can be very long. Take your time. Write down questions you have, note parts that you would like more information about and discuss these issues with your clinical trial team before deciding whether on not to participate in the clinical trial.

ASSENT
In most states, children over a certain age must be part of the decision of whether or not they will participate in a clinical trial. As part of the informed consent process, the child is given an informed assent form that functions much like the parent informed consent form.

The assent form gives the child basic information about the clinical trial, what they will be asked to do, how long it will go on, what the possible risks and benefits to them are. The child will also be given the opportunity to discuss any questions or concerns with the clinical trial team (PDF) before making his or her decision.

THE CLINICAL TRIAL TEAM
Parents should be familiar and comfortable with the clinical trial team. The team is prepared to answer any and all questions throughout the clinical trial and not just at the beginning. It is important to know who to call for general questions related to the trial and who to call in an emergency:

• Principal Investigator (PI): is a medical doctor and is responsible for the entire study at that location. He or she oversees the care of all the participants while they are in the study. The PI can sometimes be your child’s regular doctor.
• Research Nurse(s): can be responsible for recruiting people to participate in the clinical trial. They also help to determine whether or not your child is eligible to participate and can sometimes provide treatment. Research nurses can also collect trial information or data and follow up with participants.
• Research Coordinator(s): make sure the study runs smoothly. Coordinators understand all parts of the study and make sure the clinical trial staff has the right equipment, medication or devices needed to run the study.

The clinical trial study team must follow a study protocol, or plan, which lists exactly what researchers will do in the trial. An Institutional Review Board or IRB that monitors the safety of the clinical trial approves the protocol and informed consent/assent forms.

INSTITUTIONAL REVIEW BOARD (IRB)
An Institutional Review Board or IRB is an independent group of health care providers, experts in the field of the clinical trial, and community members who help to ensure that clinical trials are fair and safe. Before a clinical trial can begin, it must have the approval of an IRB.

The IRB is responsible for

• approving and reviewing the detailed study plan, or protocol
• monitoring the trial as long as it continues
• reviewing and approving study subject informed consent/assent forms

Many larger hospitals and universities have their own in-house IRBs that approve and monitor all studies that take place within the hospital. Smaller hospitals and private doctor’s offices or outpatient clinics can use the services of a regional IRB. Both types of IRBs are qualified to oversee the safety of clinical trial subject safety.

When you are thinking about joining a study, remember that you have the right to:

• join a research study only if you want to. You should never feel pressured or forced to join.
• be told about all the known or possible risks and benefits of the treatments in the study.
• full and complete information about what the study means for your child, what is expected of you and how the study will be done.
• ask questions about the study before you start and as the study goes on.
• know about any costs to you or your insurance company.
• know about other treatment options, if any exist, and their risks and benefits.
• privacy and to know about how your personal information will be shared and protected.
• be given a copy of the signed and dated written informed consent form when one is required.
• know about any new information that the researchers may learn about the treatments while the study is going on.
• leave a research study whenever you want. You should never be pressured to stay in a study. You cannot lose your regular 
• medical care if you leave a study.

Clinical trials are sponsored or funded by many different organizations and people including:

• doctors
• medical institutions or hospitals
• foundations
• pharmaceutical companies

in addition to federal agencies such as the

• National Institutes of Health (NIH)
• Department of Defense (DOD)
• Department of Veteran’s Affairs (VA)

Study sponsorship is listed in the informed consent form. Many times, all or most of the costs having to do with the clinical trial are covered by the sponsor. Any and all costs that you might be responsible for will be clearly outlined in the informed consent form.

When you are searching for pediatric research trials for children with 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

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.