Consent Rates Reported in Published Pediatric Randomized Controlled Trials

Objective To determine the average reported consent rate for published pediatric randomized controlled trials and whether this rate varies by trial characteristics. Study design A review of pediatric RCTs published in Medline in 2009, 2010 or 2015 was performed. Secondary analyses of prior trials, trials including adults, trials not requiring consent, or trials with missing or unclear consent data were excluded. Consent rate was defined as number of patients enrolled divided by number of eligible patients where families were approached. Random effects meta-regression was conducted to determine the weighted average consent rate. Results Of 2,347 trials identified, 1,651 were excluded. An additional 418/696 (60%) were excluded because the consent rate was missing or unclear. The average consent rate for 278 included RCTs was 82.6% (95% CI 80.3 - 84.8%) and was higher for vaccination compared with behavioral trials and for industry-funded compared with NIH or other government-funded trials. The average consent rate was under 70% for 26% of included trials. Of these trials, US trials (28/77, 36.4%) had a higher probability of consent rate Conclusions Although the average consent rate for published trials was reasonably high, approximately one-quarter of trials had consent rates below 70%. Consent rates reporting has improved over time but remains suboptimal. Our findings should assist with the planning of future pediatric RCTs, though consent data from unpublished trials are also needed.