Compliance and factors affecting reporting of spinal stenosis and spinal-fusion-related clinical trials to ClinicalTrials.gov.

INTRODUCTION

ClinicalTrials.gov is an online database that was launched in 2000 in order to help increase transparency around clinical trials. The FDA's Food and Drug Administration Amendments Act of 2007 and the subsequent Final Rule of 2016 attempted to improve compliance for reporting to the site. However, there is still significant noncompliance by researchers. This study evaluated compliance for trials related to spinal stenosis and spinal fusion.

METHODS

We utilized a previously published algorithm to predict clinical trials that were highly likely to be mandated to report. Trials found under the search criteria "Spinal Fusion OR Spinal Stenosis" and completed before June 2023 were extracted. Data was extracted from ClinicalTrials.gov on Study Status, Study Results, Interventions, Phases, Funder Type, Study Type, Study Design, Start Date, Primary Completion Date, Results First Posted and Study Locations. Additionally, the number of months between the primary completion date and the reporting of the results in the database were calculated for each study. Due to limited data points, descriptive analysis was conducted.

RESULTS

We found 86 studies that were deemed highly likely to be mandated to report. Of these trials, 13 % reported results within 12 months, and 85 % reported within 5 years. Industry (44 %) and other non-federal sources (54 %) were the primary funders, with the NIH funding none of the included studies. Median reporting times were similar across funding sources. Upon analysis, there were no factors that were significantly related to reporting in the 1-year time frame. The only significant factor for 5-year reporting was the year of study completion, with studies completed in 2016 or later showing 100 % compliance.

CONCLUSION

This study highlights improvements in reporting within 5 years since the 2016 Final Rule. However, despite regulatory efforts, there remains an increased need for reporting compliance in spinal fusion and spinal stenosis clinical trials. Continued efforts are needed to ensure increased transparency.