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PEDIATRICS Vol. 113 No. 1 January 2004, pp. 87-94

Ethical Assessment of Clinical Asthma Trials Including Children Subjects

M. Justin Coffey, AB*, Benjamin Wilfond, MD{ddagger},§ and Lainie Friedman Ross, MD, PhD||,¶

* Pritzker School of Medicine
|| Department of Pediatrics
MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois
{ddagger} Bioethics Research Section, Medical Genetics Branch, National Human Genome Research Institute, Bethesda, MD
§ Genetics Section, Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, Bethesda, Maryland

Background. The inclusion of children with asthma in clinical asthma trials is increasing, including their participation in placebo-controlled trials (PCTs). The objectives of this study are to assess whether children with asthma have been harmed by their participation in PCTs.

Methods. Seventy clinical asthma trials involving children published between January 1998 and December 2001 that involved distinct US research populations were identified. Studies were reviewed to determine whether all subjects with more than mild asthma received daily antiinflammatory medication as recommended by national guidelines. Sixty-two clinical asthma trials included data about subject withdrawal and were analyzed for the frequency of asthma exacerbations.

Results. Forty-five studies were designed as PCTs and did not require that all subjects with more than mild asthma receive antiinflammatory medications. Of 24 953 subjects, 4653 (19%) for whom data are available withdrew from research, and 1247 subjects (9.4%) withdrew from PCTs due to asthma exacerbations compared with 358 subjects (3.1%) in other trials. In PCTs, subjects withdrew more frequently from the placebo arms than the active-treatment arms and did so more frequently because of an asthma exacerbation (667 or 15% vs 580 or 6.5%). Fifty-two studies enrolled both children and adults, although only 1 performed subset analysis of the children.

Conclusions. Subjects enrolled in PCTs of asthma have been exposed to unnecessary risks and harms. Clinical asthma trials involving children and adults do not benefit children as a class because they rarely provide subset analysis of children subjects.

Key Words: asthma • clinical trials • placebo-controlled trials • children • ethics

Abbreviations: NHLBI, National Heart, Lung, and Blood Institute • ICS, inhaled corticosteroids • PCT, placebo-controlled trial • IRB, Institutional Review Board • CAMP, Childhood Asthma Management Program

Received for publication Dec 9, 2002; Accepted Mar 14, 2003.


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