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Enrolling your child in a clinical trial is an important decision, and it should be made with careful thought and consideration. As a leading pediatric research hospital, we believe in the power of research to make a difference in children’s health through better treatments, practices and disease prevention.
Everyone who is interested in research should have the information they need to make an informed decision about whether to participate in a clinical trial. Here are a few tips and resources for parents and caregivers.
What is the value of pediatric research?
The majority of children in the United States are healthy. Those who are not healthy have thousands of complex conditions that require specialized care. Unhealthy adults far outnumber children with health issues. Biomedical companies tend to focus their research investments on adult diseases because it is a larger market with fewer diseases. This makes pediatric healthcare research especially important among other institutions and academic health centers like Riley at IU Health, Indiana University School of Medicine, Indiana University School of Nursing and Indiana University School of Health & Rehabilitation Sciences. Clinical trials help doctors learn how to treat many childhood diseases that either have poor treatment options or have no successful treatments at all. Pediatric research allows us to learn how existing drugs may be used in other ways and how to modify adult treatments for children. Physicians and scientists also conduct research to find the right strategies to keep children healthy in specific circumstances. Some clinical trials are not focused on treatments, but instead explore new ways to detect, diagnose and prevent disease.
What is a clinical trial?
Most clinical trials can be categorized in one of two ways: Observational studies and Interventional studies. Clinical trials—especially interventional studies—are often the result of discoveries that start in a laboratory with basic science. In clinical trials, researchers can conduct further study on new procedures, medications and devices after an independent institutional review board (IRB) deems them ethical, worthwhile and safe to be tested with humans. Clinical trials may be conducted in phases at multiple sites across the country to get a sample of patients that is large enough to draw conclusions by scientific standards.
What are Observational studies?
These studies gather information through surveys, interviews, examinations and direct observation of patient behaviors, but they do not attempt to change anything.
What are Interventional studies?
Interventional studies are designed to try new treatments, services or tests to verify their safety and see how patients respond.
What is the value of pediatric research?
The majority of children in the United States are healthy. Those who are not healthy have thousands of complex conditions that require specialized care. Unhealthy adults far outnumber children with health issues. Biomedical companies tend to focus their research investments on adult diseases because it is a larger market with fewer diseases. This makes pediatric healthcare research especially important among other institutions and academic health centers like Riley at IU Health, Indiana University School of Medicine, Indiana University School of Nursing and Indiana University School of Health & Rehabilitation Sciences.
Why would I want to enroll my child in research?
Parents are motivated to consider clinical trials for their children by many factors. Some parents appreciate the extra level of interest and monitoring their child receives in a clinical trial, especially if their child has a serious disease. Participation in research often helps children and families use their experience to do something positive for other people. For some families, the promise of a better future for other children adds meaning to the hardships they face with an illness. Children enrolled in clinical trials are first to benefit from new therapies, and they draw strength by connecting with other families who share the same problems.
Who pays for pediatric research?
The National Institutes of Health, which is funded by U.S. citizens through taxes, is one of the biggest sources of pediatric healthcare research. Researchers at academic health centers like the one formed by Riley at IU Health and Indiana University apply for grants to support their research ideas and clinical trials. Money to support pediatric research may also come from pharmaceutical and biomedical companies, foundations, volunteer organizations and not-for-profit health organizations.
Can anyone participate in a clinical trial?
Not everyone who applies for a clinical trial is accepted. Each study has a set of guidelines that must be met to make sure children can participate safely. Parents and/or guardians must give permission for children to participate and children of a certain age must give their agreement, too.
How can I decide whether to enroll my child in research if the opportunity is offered to me?
One of the best ways to make your decision is to gather information. Start by having a conversation with the physicians who may have suggested the clinical trial to you. Include a trusted friend or family member in the conversation as another set of ears to help you gain perspective on what you hear. Most clinical trials have risks and benefits. Ask researchers to share both. Find out what your responsibilities are, how long the study will last and what researchers expect to gain from the trial. Ask how it will affect your child’s existing medical care and what procedures, tests or treatments will be required. Determine who will pay for costs related to the clinical trial and whether your insurance will cover any cost that is not covered by the clinical trial.
How can I volunteer for a clinical trial?
Finding the right clinical trial for your child may be the first step to participation. One of the best ways to locate clinical trials led by Riley at IU Health physicians is through the Indiana Clinical and Translational Sciences Institute (ICTSI)—a statewide collaboration between Indiana University, Purdue University and the University of Notre Dame. Patients who are interested in participating in health-related research can also register to be matched with compatible research at INresearch.org.
The ICTSI website contains a complete list of clinical trials available in Indiana and can be sorted by the type of research and the audience. Most pediatric studies listed there are conducted at the Children’s Clinical Research Center on the campus of Riley at IU Health.
Parents and caregivers can also find clinical trials through ClinicalTrials.gov, published by the U.S. National Institutes of Health. This website lists national and international research, and you can search for pediatric clinical trials conducted in Indiana by limiting your search terms. Both sites contain useful information about how clinical trials work.
The Indiana University School of Medicine offers information about the research centers formed by Indiana University Health, Riley at IU Health and Indiana University. These centers include a broad range of biomedical research that extends beyond pediatric health.
We invite you to learn more about researchers who are members of the Department of Pediatrics and their specific areas of investigation in pediatric health.
If you are learning about clinical trials and healthcare research for the first time, we encourage you to explore these helpful websites.
The National Heart, Lung, and Blood Institute provides content to help the public understand the importance of pediatric research.
The World Health Organization shares information to make pediatric health research more transparent to everyone, including parents and
This American Academy of Pediatrics website explains what parents should know about enrolling their children in clinical trials.
Families can use this information to learn more about research studies that involve people. This content can help families make an informed decision about whether to participate in a clinical trial.
Parents can use this site, published by the U.S. Food and Drug Administration, to understand the implications of participating in a clinical trial.