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(Hypertension. 2003;42:865.)
© 2003 American Heart Association, Inc.

Brief Review

Ethics of Placebo Use in Pediatric Clinical Trials

The Case of Antihypertensive Drug Studies

From the Pediatric Hypertension Program, Division of Pediatric Nephrology, Children’s Hospital at Montefiore, and Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY.

Correspondence to Joseph T. Flynn, MD, MS, Division of Pediatric Nephrology, Montefiore Medical Center, 111 East 210th St, Bronx, NY 10467. E-mail jflynn{at}montefiore.org

Industry-sponsored pediatric clinical trials of antihypertensive medications have greatly increased in number since passage of the Food and Drug Modernization Act of 1997. This development should ultimately benefit the treatment of hypertensive children by increasing the amount of scientific knowledge regarding the efficacy and safety of antihypertensive agents in children. However, the designs of many of these trials raise ethical questions related to the inclusion of placebo controls, a practice that has largely been abandoned in trials of antihypertensives in adults because of the well-known adverse consequences of untreated hypertension. This is an especially important issue in pediatric hypertension, as many hypertensive children have either secondary forms of hypertension or hypertension-induced target organ damage, potentially increasing the risk of harm during exposure to placebo. Against this background, and with a strong emphasis on protection of this vulnerable patient population, a strict set of conditions for use of placebos in pediatric antihypertensive trials is proposed.

Key Words: ethics • hypertension, secondary • antihypertensive agents • clinical trials • placebo

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