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About SickKids

April 9, 2010

SickKids study points to growing gap between paediatric and adult clinical trials

Health-care professionals rely on solid clinical trials to help them assess the benefits of treatment. Clinical trials are an integral part of evidence-based medicine and lead to improved outcomes for many conditions in children and adults. However, conducting studies with children can be more challenging than with adults, mainly due to logistical, financial and ethical factors.  Scientists from The Hospital for Sick Children (SickKids) have found that there is a widening gap between the number of important paediatric and adult clinical trials. The study is published in the March issue of Archives of Pediatrics and Adolescent Medicine.

In the largest study of its kind, the research team looked at more than 170 journals with more than 43,000 unique clinical trials published over the last 20 years. They found the number of adult clinical trials that are published are increasing at approximately four times the rate of those that involve children.

“This gap is concerning as  clinicians need more paediatric data to make evidence-informed decisions in treating children,” says the study’s lead author, Dr. Eyal Cohen, Staff Paediatrician and Project Investigator at SickKids, Assistant Professor in the Department of Paediatrics at the University of Toronto. “A well-conducted clinical trial is the gold standard in assessing the benefits of specific therapies.”

Adult trials increased by 90.5 per cent, while paediatric trials rose by 16.9 per cent and trials involving both adults and children rose by 22.7 per cent.  

The authors recommend that more funding and incentives be provided for clinicians and industry partners to conduct trials in children. They point to legislative efforts in the US and Europe to extend market exclusivity to pharmaceutical companies that conduct paediatric clinical trials.

“Hopefully, new initiatives recently launched in the US and Europe will begin to reduce the growing knowledge gap between paediatric and adult medicine,” says Cohen.

The researchers will be watching the effects of this recent legislation to see its impact.

The study was supported by The Paediatric Outcomes Research Team funded by a grant from SickKids Foundation.