Only 3.3% of NIH-Funded Pediatric Clinical Trials Data Is Reusable

In a research letter published in JAMA Network Open on July 25, 2023, scientists evaluated data availability from pediatric clinical trials funded by the National Institutes of Health (NIH). According to the letter, the NIH promotes improved data sharing by requiring all grant applications to include data management and sharing plans, starting January 25, 2023.

The cross-sectional study that this research focuses on assessed clinical trials with NIH grants that closed between 2017 and 2019. Researchers excluded clinical trials without published results in a peer-reviewed journal by June 30, 2022.

The letter also noted that two authors reviewed each clinical trial that enrolled patients under 18 years of age and evaluated them based on affiliation with the International Committee of Medical Journal Editors (ICMJE).

Investigators extrapolated data from 213 clinical trial publications. Only 32.4% of clinical trials had a data sharing statement, while even less, 29.1%, said that they had data available. The 29.1% of publications with self-proclaimed data availability amounted to 62 trials. However, only 30 (48.4%) of those studies provided individual participant data.

Although data were available for some studies, most data were acquired through direct requests to the author, accounting for 69.4% of all shared data. Meanwhile, the data repository requests data set linking accounted for 19.4% and 11.3% of all transmitted data. Despite 12 trials having data repository sets, only eight were able to verify the data.

“This study’s findings suggest that data for most NIH-funded pediatric clinical trials were not readily available for reuse. These findings are consistent with prior studies indicating that access to individual trial participant data remains limited, even among trials published in ICMJE-affiliated journals,” wrote scientists in the JAMA letter.

Data sharing has consistently been an issue in pediatric clinical trials. In fact, another study published in JAMA Network Open earlier this year explained that only 55% of all pediatric clinical trial results are published within four years of trial completion.

The study evaluated 413 studies with over $9 billion in NIH funding. However, researchers found that only 85.7% of government-funded pediatric clinical trials were registered on ClinicalTrials.gov, and even fewer (13.3%) reported results within one year of study completion.

These two studies are clear demonstrations of data-sharing issues in pediatric clinical trials. With the complexities of pediatric clinical trials and the astronomical costs, effective data sharing has the opportunity to expedite pediatric healthcare developments at a reduced price. While this is a hypothetical conclusion, clinicians and healthcare organizations are urged to continue leveraging data sharing for scientific development.