NIH Launches New Web Site for Parents on Medical Research Studies for Children
News Oct 06, 2008
The Web site (www.ChildrenAndClinicalStudies.nhlbi.nih.gov) 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.
In June, the main 10-minute video earned three Telly awards, including a silver (the highest award) in education. The prestigious Tellys honor outstanding local, regional, and cable TV commercials and programs; film and video productions; and web ads, videos and films.
"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, M.D., director of NIH's National Heart, Lung, and Blood Institute, which developed the Web site. "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 enroll their child in a study."
The Web site 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 pediatric research on asthma, heart disease, sickle cell anemia, obesity, and other conditions -- developed the Web site 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, M.D., president of the American Academy of Pediatrics and professor, Department of Pediatrics 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 enroll 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 Web site 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 enroll 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
"It's perfectly natural for parents to be concerned about the risks and benefits of enrolling their child in a research study," notes Gail Pearson M.D., Sc.D., an NHLBI pediatric cardiologist who oversees the Pediatric Heart Network. "They should know that there is almost no other time in a child's life that they will have as many safeguards brought to bear on their well being than when they are in a clinical trial."
Gathering information is key for parents to feel comfortable, adds one parent, whose daughter is participating in a study on a treatment for Marfan syndrome, a hereditary condition that weakens connective tissue, often leading to dangerous problems in the heart and blood vessels, as well as bones and joints, eyes, and lungs. In the video, she suggests that other parents "get the information [about the study] so you can make an honest decision about what you're going to be doing. Your child is sick, and this study may help, or it might not. But it may help someone, some day."