Including More Children

In June 1996, the National Institutes of Health (NIH) and the American Academy of Pediatrics held a joint workshop evaluating the participation of children in clinical research. Both groups were concerned that treatments developed and tested through clinical trials involving adults were being used to treat children without having adequate data on this special population. One of the outcomes of the workshop was a recommendation that the NIH develop a policy for including children in clinical research. This led to the following two events:

• An NIH announcement (January 1997) stating that the NIH was engaged in developing a policy and plan for requiring researchers to include children in proposed clinical trials whenever appropriate. The announcement also recommended that "when there is a sound scientific rationale for including children in research, investigators should be expected to do so unless there is a strong overriding reason that justifies their exclusion from the studies." Applicants for NIH funding would now be expected to address this issue in their proposals.
• NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects (March 1998): This policy states that children "must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. Therefore, proposals for research involving human subjects must include a description of plans for including children. If children will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion." In other words, any clinical trial for a disease that affects both adults and children must include children, unless there is a compelling reason not to do so. For instance, a new treatment might present more risk than is allowed for children, or it might make more sense to conduct a separate clinical trial for them.

The NIH's Office of Extramural Research provides information on its Web site about the plan for the inclusion of children policy.

The U.S. Food and Drug Administration (FDA) has taken steps to encourage the evaluation of new drugs for children with serious medical conditions. Towards this goal, the FDA has proposed regulations calling for changes in the testing of prescription drugs. These changes would ensure that manufacturers specifically examine the drugs effects on children if the medications are to have clinically significant use in children. For more information about the FDA's efforts to involve more children in drug trials, go to the pediatric medicine section of the FDA Web site.