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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
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Large Pediatric Randomized Clinical Trials in ClinicalTrials.gov
Stephanie M Cho1, Stylianos Serghiou2,3, John Pa Ioannidis1,2,3
1Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California94305.
Pediatrics
|September 1, 2021
Summary
Large pediatric randomized controlled trials (RCTs) are underfunded by industry and often unpublished. Aligning research with the global burden of childhood disease is crucial for improving child health outcomes worldwide.
Area of Science:
- Pediatric clinical research
- Global child health initiatives
- Evidence-based medicine
Background:
- Large, randomized controlled trials (RCTs) are critical for advancing child health.
- Assessing the landscape of pediatric RCTs is essential for identifying research gaps.
Purpose of the Study:
- To provide a comprehensive overview of large pediatric RCTs.
- To analyze funding, geographic distribution, outcomes, and publication status.
- To evaluate the alignment of these trials with the global burden of pediatric disease (GBD).
Main Methods:
- Systematic review of large (≥1000 participants), noncluster, nonvaccine pediatric RCTs registered in ClinicalTrials.gov.
- Analysis of funding sources, participant countries, reported outcomes, and publication status.
- Correlation analysis with pediatric GBD data.
Main Results:
- 247 large pediatric RCTs were identified; only 17 were mega-trials (≥5000 participants).
- Industry funding was limited (21% involved, 19% exclusively funded).
- Trials were conducted in high-income countries (40%) and lower-middle-income countries (49%), with notable investigator presence from high-income countries in LMIC trials.
- A significant proportion of completed trials (35%) remained unpublished.
- Trial distribution correlated well with overall pediatric GBD, particularly in LMICs, but less so in HICs.
Conclusions:
- There is a need to incentivize international collaborations for large pediatric RCTs.
- Timely publication of pediatric RCT results is crucial.
- Better alignment of pediatric RCTs with the global burden of disease is necessary to improve child health globally.
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