460 - Data Sharing for NIH-Funded Pediatric Clinical Trials

The National Institutes of Health (NIH) has a long-standing commitment to data sharing to increase transparency and maximize the value of clinical research through reuse of data. Further, in 2018, the International Committee of Medical Journal Editors (ICMJE) implemented a clinical trial data sharing policy for submissions in member journals. The impact of these efforts on the availability of pediatric clinical trial data has not been examined.

Objective:

To assess availability of data sharing statements and investigator intent to make clinical data available among NIH-funded pediatric clinical trials.

Design/Methods:

This cross-sectional study analyzed NIH-funded pediatric clinical trials (i.e., those that enrolled participants aged < 18 years), with grants completed in 2017-2019, and trial results published in 2018 or after. Publications were reviewed for data sharing statements and information was collected on the type of data access described. Journals were categorized according to ICMJE affiliation (i.e. journals stating they follow the ICMJE policies). Descriptive analyses were performed on the presence of data sharing statements and type of clinical data sharing. The X2 test was used to assess differences in frequency and content of data sharing statements based on ICMJE journal affiliation.

Results:

Among 189 NIH-funded pediatric clinical trials, 34% (n = 65) included a data sharing statement in the trial publication (Table). Publications in ICMJE-affiliated journals were not more likely to include a data sharing statement than those in non-ICMJE journals (42% vs 30%, p=0.09). Most data sharing statements declared intent to share data (n=59, 91%), including 6 (9%) providing a link to retrieve the data, 42 (65%) stating data were available upon request from the investigator, and 11 (17%) requiring a request to a data repository. The type of data availability did not differ among publications in ICMJE-affiliated journals compared to those not affiliated with ICMJE. Overall, only 6 (3.2%) pediatric clinical trial publications provided data that could be directly downloaded and used.

Conclusion(s):

Most publications of NIH-funded pediatric clinical trials did not include a data sharing statement, even when published in an ICMJE-affiliated journal. Further, few provided data that could be readily reused. Additional actions may be required to ensure efficient access and reuse of high-value pediatric research datasets.