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Children's Assent to Clinical Trial Participation
    Posted: 01/11/2001    Reviewed: 05/26/2005



Background






The Assent Process






When Assent Is Not Required






What's Required by Law






Assent Is Essential






Including More Children



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Assent Is Essential

Over the past few years, the National Institutes of Health, the U.S. Food and Drug Administration, and the American Academy of Pediatrics have emphasized the need to include more children and adolescents in clinical trials. You may be wondering why this is even necessary --wouldn't it just be simpler to require that all trial participants be over age 18? While it might be simpler, it would not be good medical practice. Many diseases only affect children, and advances in treating these diseases depends on research studies. For those diseases that do affect both adults and children, a treatment that helps adults may not help children in the same way.

Fortunately, there are many cancer clinical trials designed specifically for children because childhood forms of cancer are often very different from adult forms. Researchers studying new treatments for adults with cancer generally do not include children in their clinical trials, but instead are encouraged to work with pediatric cancer specialists to assure timely and appropriate evaluations of their new treatment approaches in children.

For many years, the NCI has supported a nationwide clinical research system focusing exclusively on children. The research system is devoted to developing and carrying out clinical trials to identify more effective treatments for children with cancer. This network involves hundreds of researchers from the U.S. and around the world who have joined forces to form the Childrens Oncology Group (COG) . The NCI also supports the Pediatric Brain Tumor Consortium, a network of medical centers that work together to evaluate promising treatments for children with brain tumors, and the New Approaches to Neuroblastoma Therapy (NANT), a consortium of research institutions investigating early phase therapies for high-risk and relapsed neuroblastoma. Furthermore, the NCI's own Pediatric Oncology Branch conducts phase I and phase II trials for children whose cancer has recurred or has not responded to treatment.

You can find most of these pediatric cancer trials through the NCI's database of clinical trials. If you go to the database and look at the scroll-down menu under "types of cancer," you will see that you can search for trials specific to childhood forms of cancer such as brain tumor and leukemia. Furthermore, if you choose a type of cancer that is more common in children, such as Wilms' tumor or retinoblastoma, you will find trials designed specifically for them.

You can also call the NCI's Cancer Information Service at 1-800-4-CANCER for assistance locating a clinical trial.

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