Abstract
IntroductionPromoting emergency medicine (EM) clinical trials research remains a priority. To characterize the status of clinical EM research, this study assessed trial quality, funding source, and publication of EM clinical trials and compared EM and non-EM trials on these key metrics. We also examined the volume of EM trials and their subspecialty areas.MethodsWe abstracted data from ClinicalTrials.gov (February 2000 – September 2013) and used individual study National Clinical Trial numbers to identify published trials (January 2007 – September 2016). We used descriptive statistics and chi-square tests to examine study characteristics by EM and non-EM status, and Kaplan-Meier curves and log-rank tests to compare time to publication of completed EM and non-EM studies.ResultsWe found 638 interventional EM trials and 59,512 non-EM interventional trials conducted in the United States between February 2000 and September 2013, registered on ClinicalTrials.gov. EM studies were significantly less likely than non-EM studies to be National Institutes of Health-funded or to evaluate a drug or biologic. However, EM studies had significantly larger sample sizes, and were significantly more likely to use randomization and blinding. Overall, 34.3% of EM and 26.0% of non-EM studies were published in peer-reviewed journals. By subspecialty, more EM trials concerned medical/surgical and psychiatric/neurological conditions than trauma.ConclusionAlthough EM studies were less likely to have received federal or industry funding, and the EM portfolio consisted of only 638 trials over the 14-year study period, the quality of EM trials surpassed that of non-EM trials, based on indices such as randomization and blinding. This novel finding bodes well for the future of clinical EM research, as does the higher proportion of published EM than non-EM trials. Our study also revealed that trauma studies were under-represented among EM studies. Periodic assessment of EM trials with the metrics used here could provide an informative and valuable longitudinal view of progress in clinical EM research.
Highlights
Promoting emergency medicine (EM) clinical trials research remains a priority
We found 638 interventional EM trials and 59,512 non-EM interventional trials conducted in the United States between February 2000 and September 2013, registered on ClinicalTrials.gov
EM studies were less likely to have received federal or industry funding, and the EM portfolio consisted of only 638 trials over the 14-year study period, the quality of EM trials surpassed that of non-EM trials, based on indices such as randomization and blinding
Summary
Promoting emergency medicine (EM) clinical trials research remains a priority. To characterize the status of clinical EM research, this study assessed trial quality, funding source, and publication of EM clinical trials and compared EM and non-EM trials on these key metrics. Quality and Publication of EM Trials Registered in ClinicalTrials.gov discussions focused on advancing research in three broad areas: trauma; neurological and psychiatric emergencies; and surgical or medical emergencies.[6] In light of these reports and recommendations, we aimed to characterize the status of clinical EM research and to compare EM with non-EM studies. We restricted our assessment to clinical trials, essential components of evidence-based medicine and of interest to the National Institutes of Health (NIH), which promotes funding opportunities for high-quality, multisite EM trials.[7] We based our assessment on several metrics: study quality; funding source; and dissemination of study findings These metrics provide quantifiable measures of clinical EM research that can be used going forward to evaluate the characteristics and productivity of this research over time. We examined the distribution of trials across EM subspecialties (neurological/psychiatric, trauma, medicalsurgical), which may help to direct funding to under-researched areas, and we examined the volume of EM registered trials by year and funding source, to assess trends
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
