Measurements Poor for Assessing Clinical Trials With Children
TUESDAY April 29, 2008 -- 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.
The U.S. Food and Drug Administration has more about children and clinical trials.
Posted: April 2008