National Academies news: Clinical research involvin...( ent years to expand pediatric research...),Health

ent years to expand pediatric research, especially studies that test the safety and efficacy of drugs for children. Infants, young children, and adolescents have been called "therapeutic orphans" because drug companies have been reluctant to do tests in these groups after medications have been approved for adults. All too often, physicians have to make the choice of not prescribing particular medications for children, or extrapolating drug doses based on data from studies with adults. However, extrapolation may lead to children getting too much or too little of a drug, or suffering adverse effects not seen with adults, the report says. And extrapolation cannot generate a reliable knowledge base for future clinical care.

The government also has taken steps to more closely review human research in general, and has even temporarily suspended federally funded studies at several leading medical centers after finding deficiencies in their research review programs. Most attention has focused on research involving adults, however. An effective and adequately funded system for protecting all human research participants is essential, but safeguarding child participants requires extra attention and resources, says the report, which the Best Pharmaceuticals for Children Act requested.

A LOOK AT REGULATORY FRAMEWORKS; INTERPRETING RISKS

HHS published in 1973 the first general regulations on protecting human participants in research, often referred to as the "Common Rule." These regulations require that risks to participants be minimized; risks be outweighed or balanced by anticipated benefits; research participants be equitably recruited; and investigators obtain informed consent from them. Ten years later, HHS published the first regulations specifically governing federally supported or conducted research involving children. These rules define categories of research that may be approved. Under most circumstances, they call for parents
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Contact: Vanee Vines
news@nas.edu
202-334-2138
The National Academies
26-Mar-2004

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