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Consent and recruitment: the reporting of paediatric trials published in 2012
Allison Gates1,2, Patrina Caldwell3, Sarah Curtis2
1Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, Alberta, Canada.
Insights
Most pediatric trials use standard recruitment, but reporting on consent, information targeting, and incentives is often insufficient. This lack of detail hinders understanding of recruitment success in clinical research.
Area of Science:
- Clinical Trials
- Pediatric Research
- Research Methodology
Background:
- Effective recruitment is crucial for pediatric clinical trials.
- Understanding current recruitment and consent practices is essential for improving trial design.
- Previous evaluations have highlighted variability in reporting standards.
Purpose of the Study:
- To evaluate consent and recruitment strategies in pediatric trials.
- To determine the target audience for trial information.
- To assess the use and effectiveness of incentives in pediatric research recruitment.
Main Methods:
- Cross-sectional evaluation of 300 randomly selected pediatric trials published in 2012.
- Data collection on consent, recruitment procedures, information targeting, and incentives.
- Descriptive analyses using SPSS statistics V.23.
Main Results:
- 99.7% of trials used standard recruitment; 92% obtained consent, but only 13% reported who obtained it.
- 65% of trials included school-aged participants, with 68% obtaining assent.
- Information targeting was reported by 50% of trials, often directed at children or parents; 14% used incentives.
Conclusions:
- Significant reporting gaps exist regarding recruitment, consent, information dissemination, and incentive use in pediatric trials.
- Paediatric-specific reporting standards are needed to enhance transparency and consistency.
- This study provides a baseline for monitoring reporting quality in pediatric clinical research.
Objectives:
We evaluated 300 paediatric trials to determine: the consent and recruitment strategies used, who trial information was targeted to, how incentives were used and if they achieved their recruitment targets.
Methods:
For this cross-sectional evaluation, we searched the Cochrane Central Register of Controlled Trials for paediatric trials published in 2012 and randomly selected 300 that reported on outcomes for participants aged ≤21 years. We collected data on consent and recruitment procedures for each trial and undertook descriptive analyses in SPSS statistics V.23.
Results:
All but one trial (99.7%) used a standard recruitment strategy. Most (92%) trials reported that consent was obtained but only 13% reported who obtained consent. Two-thirds (65%) of trials included school-aged participants, and of these 68% reported obtaining assent. Half (50%) of the trials reported who the trial information was targeted to. Most trials (75%) of school-aged participants targeted information towards children or children and their parents. Fourteen per cent of trials reported using incentives, half (50%) of which were in the form of compensation. Only 48% of trials reported sufficient data to determine if their recruitment targets were achieved. Of these, 70% achieved their targets.
Conclusions:
Notable reporting shortcomings included: how families were recruited into the trial, who obtained consent and/or assent and how, who trial information was directed to, whether incentives were used and sufficient data to determine if the recruitment target was achieved. Forthcoming paediatric-specific reporting standards may improve reporting in this priority area. Our data provide a baseline for ongoing monitoring of the state of the research.
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