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Consent Rates Reported in Published Pediatric Randomized Controlled Trials.

Julia A Lonhart1, Ashley R Edwards1, Swati Agarwal2

  • 1Stanford University School of Medicine, Palo Alto, CA.

The Journal of Pediatrics
|June 30, 2020
PubMed
Summary
This summary is machine-generated.

The average consent rate for pediatric randomized controlled trials (RCTs) is 82.6%, but nearly a quarter of trials report rates below 70%. Improved consent reporting is needed for future pediatric clinical research.

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Area of Science:

  • Pediatric clinical research
  • Medical ethics
  • Biostatistics

Background:

  • Informed consent is crucial in pediatric randomized controlled trials (RCTs).
  • Understanding reported consent rates and their variability is essential for ethical research planning.
  • Previous assessments of consent rates in pediatric RCTs are limited.

Purpose of the Study:

  • To determine the average reported consent rate for published pediatric RCTs.
  • To investigate whether consent rates vary based on trial characteristics such as funding and therapeutic area.
  • To identify trends and areas for improvement in consent reporting for pediatric research.

Main Methods:

  • A systematic review of pediatric RCTs published in 2009, 2010, and 2015 was conducted.
  • Trials with missing or unclear consent data were excluded.
  • Random effects meta-regression was used to calculate the weighted average consent rate.

Main Results:

  • The average consent rate across 278 included pediatric RCTs was 82.6%.
  • Consent rates were higher for vaccination trials and industry-funded trials compared to behavioral or government-funded trials.
  • Approximately 26% of trials reported consent rates below 70%, with US trials showing a higher probability of lower consent rates.

Conclusions:

  • While the average consent rate is high, suboptimal reporting exists in a significant portion of pediatric RCTs.
  • Consent reporting has improved but remains an area needing attention for future pediatric research.
  • Findings can inform the design of future pediatric RCTs, though data from unpublished trials are also needed.