More Criticism of Pediatric Clinical Drug TrialsMay 1, 2008 | Parker Waichman LLP
In March, experts at Great Britain’s University of Nottingham reported that the methods and processes in which drug trials are conducted in children require more and stricter monitoring and more needs to be done to ensure the children’s safety. Now, University of Liverpool researchers are saying that few studies consider the appropriate measurements for assessing drug clinical trials that enroll children. Liverpool researchers reviewed 9,000 pediatric clinical trials conducted since 1950. The researchers also found that few studies involved parents and none of the studies involved children in the process to select which measurements to use in assessing clinical trials. The study was published this week in the journal PLoS Medicine.
Before a new drug undergoes clinical trial, its researchers choose several outcomes, or measurements, that provide as much information as possible about the drug's safety, effectiveness, and impact on the patients' health and daily life. But, it’s a relatively well-known fact that children's bodies handle drugs very differently than adults' bodies; it cannot be assumed those drugs that work in adults can simply be used in smaller doses for children. Because of this, experts feel that pediatric clinical trials should be designed with these differences in mind.
Of the 9,000 studies, a mere 25 met the criteria established by the review and examined the selection of outcomes in clinical research in children. Those 25 studies originated from 13 groups researching a number of conditions, including asthma, cystic fibrosis, and Crohn’s disease. Unfortunately, the researchers concluded that there has been no work into the selection of appropriate outcomes for pediatric clinical trials for those conditions that specifically affect children. The researchers reported that it is important that an agreement on standard outcomes for clinical trials in children be reached to allow for result comparison and combination from different trials; standardization also helps reduce selectivity and bias in research.
Meanwhile, the March study—published in the Acta Paediatrica journal and reported by the University of Nottingham team—reported that current monitoring of the testing methods in children were "unacceptable." The researchers also said that independent oversight was necessary. The team also found that adverse drug reactions, including bleeding, high blood pressure, and seizures, were reported in just over a third of those patients involved in the trials studied. It was also found that trials utilizing independent monitoring committees were more likely to be terminated early in the event of problems such as adverse reactions. In total, six trials were ended and all six that were ended early had the oversight of independent committees. The researchers said they would not expect the findings have any different results for those trials involving adults.
The Medicines for Children Research Network has been established in England by the Department of Health and comprises six local research networks and will have the potential to recruit children to carry out clinical studies on drugs—new chemical entities and those already used off-label or unlicensed—to children. Simultaneously, the European Medicines Agency is coordinating European networks for research on drugs for children. The option for third-party oversight safety committees was not discussed.