Are the pharmaceutical industry and the National Institutes of Health doing enough to enroll children in clinical trials? No, claims a new study published in the journal Pediatrics and supported by the Clinical Trials Transformation Initiative (CTTI), an organization that partners with the US Food and Drug Administration (FDA) and numerous other government agencies.
The study, "Status of the Pediatric Clinical Trials Enterprise: An Analysis of the US ClinicalTrials.gov Registry," published 1 October 2012, looked at all interventional clinical trials registered with US officials between July 2005 and September 2010.
Its conclusion: Children are enrolled in clinical trials at a far lower rate than adults.
"Although children comprise one-quarter of the population in the United States, they are greatly underrepresented in the clinical trial process that is designed to lead to new and better therapies, determine appropriate drug dosages and establish standards of practice," said Sara Pasquali, MD, the lead author of the study.
Between 2005 and 2010, the authors found 5,035 studies were specifically designed to include children, or 9% of all trials. Adults, meanwhile, were the focus of more than 55,000 trials, or 91%, leaving children vastly underrepresented relative to their population numbers.
Researchers said much of the discrepancy can be attributed to the difficulty of setting up trials for pediatric diseases, which are often rarer than their adult counterparts and therefore require more time and resources to set up.
But even for relatively basic ailments, such as infectious diseases and mental health, studies lag, causing a shortage of useful information for clinicians.
"For the vast majority of therapies used on children every day in United States and around the world, clinicians lack basic data to support decisions about the correct dosage, the best type of medication to use, and the appropriate situations to provide treatment," Pasquali said. "Without that information, it really puts physicians and the children we're treating at a significant disadvantage."
The study is similar to one published in July 2012, also in Pediatrics, which found that just 12% of sampled trials enrolled children.
Pasquali's study was supported by a grant issued by FDA.