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Published on: January 12, 2018
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Research waste among randomized controlled trials in preterm infants: a Cross-sectional study
Cuncun Shen1, Jingjing Qiu1, Yanxia Qiao1
1Department of Neonatology, The Fourth Hospital of Shijiazhuang, Shijiazhuang, China.
Summary
Nearly 70% of randomized controlled trials (RCTs) for preterm infants resulted in research waste, including non-publication or poor reporting. Large-scale trials in North America and Europe showed less waste.
Area of Science:
- Neonatal research
- Clinical trial methodology
- Evidence-based medicine
Background:
- Randomized controlled trials (RCTs) are crucial for medical efficacy evaluation.
- However, RCTs can lead to significant research waste.
- This study focuses on research waste in trials involving preterm infants.
Purpose of the Study:
- To assess the extent of research waste in randomized controlled trials involving preterm infants over the past two decades.
- To identify factors contributing to research waste in this population.
Main Methods:
- A cross-sectional search of ClinicalTrials.gov (2001-2020) identified RCTs involving preterm infants.
- Research waste was defined as non-publication, poor reporting, or design deficiencies.
- Publication status, reporting adequacy (CONSORT checklist), and design deficiencies (risk of bias, systematic reviews) were evaluated.
Main Results:
- 100 RCTs were included, primarily focusing on pulmonary, nutritional, and ophthalmological diseases.
- 69% of RCTs exhibited research waste (non-publication, inadequate reporting, or design deficiencies).
- Publication was more common in trials with >300 participants. Investigator location (North America/Europe) and larger enrollment size were associated with reduced research waste.
Conclusions:
- A substantial proportion (nearly 70%) of RCTs concerning preterm infants contribute to research waste.
- Large-scale trials and those led by researchers in North America or Europe demonstrated less research waste.
- Improving trial design and reporting can mitigate waste in neonatal research.
