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Ethical Conduct of Clinical Research Involving Children
quality of life for countless others. Beyond the infants, children, and adolescents directly affected, the benefits of research extend to the families, friends, and communities who love and care for them.
Since the 1950s, research has led to polio, measles, and other vaccines that have dramatically cut child deaths, disability, and discomfort from communicable diseases (CDC, 1999). Similarly, many premature babies with underdeveloped lungs who once would have died now survive with the use of mechanical ventilators and surfactants (substances that make breathing easier). Statistical analyses of clinical trial data have suggested a 30 to 40 percent absolute decrease in the number of deaths among affected infants after the adoption of surfactant therapy (Jobe, 1993). With improved therapies, the rate of mortality from acute lymphocytic leukemia (formerly called acute lymphoblastic leukemia) dropped by 65 percent between 1975 and 1999 for children under age 20 years (Ries et al., 2003).
Children and their families have also benefited from research identifying the unanticipated harms or ineffectiveness of what were once standard therapies. For example, in the 1940s and early 1950s, an epidemic of blindness occurred among premature newborns who were routinely treated with high-dose oxygen, which at that time was almost universally viewed as reducing the risk of anoxic brain injury (Silverman, 1977). Three controlled clinical trials demonstrated oxygen’s toxic effects on the developing retina (James and Lanman, 1976). Another once widely used practice that long-term follow-up studies showed to be dangerous was irradiation for purported thymus enlargement in young children (see, e.g., Shore et al., 1985, 1993).
Despite many advances, pediatricians have argued that infants, young children, and adolescents have not shared equally with adults in the achievements of biomedicine (see, e.g., AAP, 1977, 1995). Most attention has focused on pharmaceutical research. Surveys of the Physician’s Desk Reference (a comprehensive guide to pharmaceuticals that includes prescribing information) found in 1973 and again in 1991 that approximately 80 percent of the medications listed had no prescription information for children (Wilson, 1975; Gilman and Gal, 1992; both cited in AAP, 1995). These analyses did not assess which drugs were realistically candidates for use with children, but they nonetheless suggested an information gap for clinicians and families who were searching for safe and effective medications for sick children. This information gap leaves physicians with the choice of not prescribing such medications for children (and thus potentially undertreating them) or using the medications based on their or their colleagues’ experience and judgment about whether and how data from studies with adults might apply to children of different ages.
In fact, children differ physiologically from adults in myriad ways that can affect how drugs work in the body. Extrapolation based on adult drug