- TUESDAY, April 29 (HealthDay News) — Few studies consider the
appropriate measurements for assessing drug clinical trials that enroll
children, say University of Liverpool researchers who reviewed 9,000
pediatric clinical trials conducted since 1950.

They also found that few studies have involved parents, and none have
involved children in the process to select which measurements to use in
assessing clinical trials.

Before they conduct a clinical trial of a new drug, researchers choose
several outcomes — measurements that provide as much information as
possible about the drug's safety, effectiveness and impact on the
patients' health and daily life, according to background information in
the review.

Children's bodies handle drugs very differently than adults' bodies,
and it can't be assumed that drugs that work in adults can simply be used
in smaller doses to treat children. Pediatric clinical trials need to be
designed with these differences in mind.

Of the 9,000 studies, only 25 met the criteria established by the
review and examined the selection of outcomes in clinical research in
children. The 25 studies came from 13 groups researching a number of
conditions, including asthma, cystic fibrosis and Crohn's disease.
However, for many conditions that affect children, there has been no work
done into the selection of appropriate outcomes for pediatric clinical
trials, the review authors said.

They said reaching agreement on standard outcomes for clinical trials
in children is important, because it allows comparison and combination of
results from different trials. Standardization also helps avoid
selectivity and bias in the conduct of research.

The study was published this week in the journal PLoS
Medicine.

More information

The U.S. Food and Drug Administration has more about children and clinical trials.