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Medicines, devices, and treatments are often only tested in adults and not in children. Historically, only 20-30% of drugs approved by the U.S. Food and Drug Administration (FDA) have been licensed for use in children. According to the FDA, medical research and clinical trials can yield important information on a medical product s safety, dosing, and effectiveness. This becomes the basis for FDA approval and product labeling. In turn, health care providers use this information to prescribe the right medication/product for their patients.
Children’s response to drugs can t always be predicted from data collected in adult studies. Adult treatments may not always work the same way in children. But without research in children themselves, we have no choice but to treat them as adults. Infants, toddlers, and school age children may all need different dosing schedules and the only way to determine this is to have children participate in research studies.
Deciding whether to let your child participate in a research study or clinical trial is an important decision for parents and families. All research studies must be conducted according to strict guidelines and regulations that are designed to protect the rights and well-being of you and your child. These rules are set out by groups such as Health Canada, the U.S. Food and Drug Administration, Research Ethics Boards, and Hospital Review Committees. Clear and strict rules help increase the chance that the benefits of participating in a study outweigh any possible risks.
The clinical research staff are highly trained on the rights of participants and how to conduct studies in an ethical, legal and safe way. Staff are there to ensure that parents and participants understand the methods and procedures of a study. The Information is explained to parents in a way that can be easily understood and parents’ questions are encouraged.
The clinical research nurse will present the information about the study ensuring that parents and participants know participation in a study is completely voluntary.
Parents are also encouraged to talk to their child s doctor to help determine whether they want their child to participate.
We appreciate the time parents and participants give listening to our recruitment nurses, even if they ultimately decide not to participate in a study.
For more information, please see the Should My Child Participate in a Research Study Brochure (PDF)
Additional information about children and clinical trials can be found on the following website:
National Heart Lung and Blood Institute Children and Clinical Studies
Click here for a list of current clinical studies.
To speak with a member of the Children’s Hospital Research Institute of Manitoba s Clinical Research Unit and for more details on children participating in research, please contact:
Chelsea Bowkett, Clinical Research Unit Administrative Coordinator
Ph: (204) 789-3206
Fax: (204) 789-3956