What is research?
Research is how doctors and scientists answer important health questions. It helps us learn which treatments work best, why some people respond differently, and how we can make care better for everyone.
How is research different from medical care?
Medical care focuses on what is best for you or your child right now. Research looks for answers that can help many families in the future. Sometimes people benefit directly from being in a study, but the main goal is to learn and improve care for everyone.
What is a research study protocol?
A protocol is like a roadmap or recipe for how a study will be done. It explains what questions the study will answer, who can join, what will happen, and when, how the research team keeps participants safe, and how results will be shared. Every study must follow its approved protocol.
What is informed consent?
Before joining a study, families review a consent form that explains what’s being studied, what’s involved, any possible risks and benefits, and your rights. Participation is always voluntary, and you can withdraw at any time—your child’s medical care won’t be affected.
What is Inflammatory Bowel Disease (IBD)?
Inflammatory Bowel Disease, or IBD, is a term for long-lasting inflammation in the digestive tract. There are two main types: Crohn’s disease and ulcerative colitis. Both can cause belly pain, diarrhea, tiredness, and weight loss, but they affect the digestive system in different ways. Crohn’s disease can occur anywhere along the digestive tract, while ulcerative colitis affects only the large intestine and rectum.
What are anti-TNF medicines?
TNF stands for tumor necrosis factor, a natural chemical made by the immune system. In Crohn’s and ulcerative colitis, TNF can trigger too much inflammation. Anti-TNF medicines block TNF to calm the immune response and help manage symptoms.
What are “emerging therapies” for IBD?
When anti-TNF medicines stop working, doctors may consider newer treatments. Some are already approved for adults and used for “off-label” for children. These include vedolizumab, ustekinumab, risankizumab, guselkumab, mirikizumab, tofacitinib, and upadacitinib. These are the medicines being compared in the COMPARE Study.
What is the COMPARE Study about?
COMPARE is a national study for children and teens with Crohn’s disease or ulcerative colitis who have already tried an anti-TNF medicine. The goal is to learn which newer medicines work best and are safest for kids.
What happens if my hospital is not a site?
Only hospitals that are part of the COMPARE study can enroll families. If your hospital isn’t one of them, you won’t be able to join the study right now, but your care team can still learn from what COMPARE finds to help guide future treatment decisions for kids and teens with IBD.
Who can join the study?
Your child may be eligible if:
- They are under 18 years old
- Have Crohn’s disease or ulcerative colitis
- Have already used at least one anti-TNF medicine
- Are starting one of the newer therapies recommended by their doctor.
When can I join the study?
Because the study focuses on what happens when kids first begin their next medicine, it’s important that families enroll before or at the time of the first dose. This helps researchers capture the most accurate information about how each treatment works from the very beginning.
Who is leading the study?
The University of North Carolina at Chapel Hill and Duke Clinical Research Institute sponsors the COMPARE Study in partnership with about 30 research sites nationwide. Parents and patients are part of the study team to ensure it reflects families’ real needs and priorities.
Will joining the study change my child’s care?
No. Your child’s doctor will continue to make all treatment decisions. There are no changes to your child’s medications or care plan. The study simply follows along to learn from your child’s regular care. No extra clinic visits or procedures are added.
What should families consider before deciding?
It’s important to understand why the study is being done and what your child will be asked to do. Your research coordinator will review everything with you and answer any questions. You’ll receive a consent form that explains these details as well.
How does COMPARE keep participants safe?
The study was reviewed and approved by an Institutional Review Board (IRB) to make sure it’s safe and ethical. Your child’s care team continues to monitor their health as usual.
How will my privacy be protected?
All data are de-identified before being shared. Names and personal details are removed, and each participant is assigned a study ID number. The study follows strict privacy and data security rules to keep your child’s information safe.
Why should I consider participating in this study?
Your participation helps researchers understand which treatments work best and are safest for children and teens living with IBD. By sharing your experience, you’re contributing to valuable knowledge that can guide doctors in making better treatment decisions and improve care for families facing IBD in the future.
What happens if my child joins the study?
COMPARE is an observational study. That means your child’s doctor, not the research team, chooses their treatment. There are no medication changes, no changes to your child’s care, and no extra clinic visits or procedures. The study simply observes and records how children do overtime while receiving their normal care.
What will participation look like for families?
You’ll start with a short baseline survey about your child’s health and treatment. After that, you’ll complete brief check-in surveys at two months, six months, one year, and then every six months for up to three years. The study team also reviews clinic and lab information already collected during your child’s regular appointments. You may be asked to provide an optional stool sample, but it’s not required.
Do we need to come in for extra visits?
No. Everything happens as part of your child’s regular medical care. Surveys can be completed at home, and the study team may contact you occasionally by phone, email, or text to confirm information or answer questions.
Who can I contact for more information?
If you have any questions or need more information, you can contact the study team at the phone number and address provided on the consent form and in your COMPARE handbook.
What are the benefits of joining?
Your child may not directly benefit, but your family will help researchers and doctors learn which treatments work best for children and teens with IBD. Every participant helps improve care for future families.
Will I be paid for participating?
Yes. Families can receive up to $280 for completing study surveys and check-ins.
Can we withdraw from the study if we change our mind?
Yes. Participation is completely voluntary. You can withdraw your child at any time without it affecting their care or relationship with their doctor.
What happens to the information collected?
When the study ends, researchers analyze the data to compare how the medicine performed. Results will help doctors understand which treatments work best and are safest for kids. Findings will be shared with families, the medical community, and published in scientific journals.
Will we be told about the results of this study?
You will be notified if we find any new information that may affect your child’s willingness to continue participating in this study.
A description of this clinical study will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify your child. At most, the website will include a summary of the results. You can search this website at any time.
The set of information used to decide the results may be made available to other researchers. This includes survey results and other health information collected from study participants. The data may be used for future studies to help children with IBD. Because it is not possible for us to know what studies may be a part of future work, by signing this consent you are giving the study team and or other researchers permission to use your child’s information for future research related to pediatric IBD. Identifying information like your child’s name, date of birth, home address, phone number, or email address will not be included in this information set.
Results of the research may also be published. If results are published, they will not contain any information that is specific to your child. Once the study is complete, there may be an opportunity to share the results of this research. If this occurs, you and or your child will be notified about how to access these results.
Will there be any benefits for my family?
Your child may not have a direct medical benefit, but your participation helps future children and families. By joining COMPARE, you’re helping researchers and doctors answer an important question that can shape better treatments for years to come.
How is my child’s privacy protected?
All data are de-identified before being shared. Names and personal details are removed, and each participant is assigned a study ID number. The study follows strict privacy and data security rules to keep your child’s information safe.
