Bias risk higher in industry-funded pediatric studies

A high proportion of pediatric, randomized controlled trials (RCTs) have a high risk for bias, particularly those that are industry-funded or involve assessment of behavioral/educational interventions, but trial registration is linked to less risk of bias, according to research published online July 12 in Pediatrics, HealthDay News reported.

Michael T. Crocetti, MD, MPH, of the Johns Hopkins Bayview Medical Center in Baltimore, Md., and colleagues evaluated pediatric RCTs from 8 high-impact journals for risk of bias within 6 domains: randomized sequence generation; allocation concealment; masking of participants, personnel, and outcome assessors; incomplete outcome data reporting; selective outcome reporting; and other sources of bias. Methods developed by the Cochran Collaboration were used to evaluate each RCT.

The researchers found that many RCTs had a high risk of bias in the domains of sequence generation and allocation concealment. Higher risk of bias for sequence generation was seen in industry-funded trials compared to government-funded trials (adjusted odds ratio [aOR], 6.1), and in RCTs involving assessment of behavioral/educational interventions compared to drug trials (aOR, 2.8). Behavioral/education trials were also more likely to have a high risk of bias for the domain of allocation concealment (aOR, 4.09). Registered trials were found to have a lower risk of sequence generation bias than non-registered trials (aOR, 0.33). RCTs with higher numbers of authors were less likely to have a high risk of bias for incomplete outcome reporting (aOR, 0.78).

“Registered trials were 68% less likely to have a high risk of bias for sequence generation, compared with non-registered trials. Increasing the number of pediatric RCTs that are registered would make trial information more accessible to the public and also could be a marker for a reduced risk of bias in trial design,&rquot; the authors wrote.