The Importance Of Children In Clinical Studies

December 2017

General Practitioners

Country of origin: USA

From asthma and cancer treatments to vaccines, research in children saves lives and improves their health and well-being. A new website from the National Institutes of Health (NIH), "Children and Clinical Studies", offers parents and health care providers an insider's guide to children's medical research. The website combines information about how clinical studies in youth are conducted with award-winning video of children, parents, and healthcare providers discussing the rewards and challenges of participating in research.

"Clinical studies are essential to improving our understanding of how to diagnose, prevent, and treat disease - as well as how to stay healthy - and this is true of children as well as adults," said Elizabeth G. Nabel, MD, director of NIH's National Heart, Lung, and Blood Institute, which developed the website. "We hope this new resource will help parents and others learn more about how clinical studies are conducted in children, so they can make well-informed decisions about whether to enrol their child in a study."

The website describes why research in children is important, how studies are conducted, and what measures are taken to protect participants' safety and privacy. NHLBI - which supports paediatric research on asthma, heart disease, sickle cell anaemia, obesity, and other conditions - developed the website in collaboration with New England Research Institutes and Hands On Productions. Additional support was provided by the NIH Foundation; NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Center for Research Resources; and the National Marfan Foundation.

"Children are not little adults - their bodies and their brains are still developing," notes Renee R. Jenkins, MD, president of the American Academy of Paediatrics and professor, Department of Paediatrics and Child Health, Howard University College of Medicine, who appears in the video. "A good example of their unique research needs is understanding how medications affect the developing child and adolescent, and clinical trials are the best way to do that."

Research studies can enrol healthy children or children with specific conditions. They can involve simple observations or health tests, such as weight and height, or more complex tests, vaccines, or treatments for a condition.

In one of the website videos, a young teen enrolled in a study of treatments for Fabry disease says that being in a research study is "going to be worth it in the long run, because I'm helping myself and future generations and people who have the disease now." Fabry disease is an inherited condition that can cause severe pain, vision problems, kidney and heart disease, and stroke.

?Children and Clinical Studies? includes a list of questions for parents to consider asking the research team when deciding whether to enrol their child in a study. Other topics include:

? How institutional review boards monitor studies for safety
? Who's who on the research team
? Important terms to know, such as informed consent and assent
? How a child's participation in a research study can affect the entire family
? The rights of families enrolled in clinical studies

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