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{
    "pk": 12830,
    "title": "Quality and Publication of Emergency Medicine Trials Registered in ClinicalTrials.gov",
    "subtitle": null,
    "abstract": "Introduction: \nPromoting 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.\nMethods:\n We 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.\nResults: \nWe 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.\nConclusion:\n Although 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.",
    "language": "en",
    "license": {
        "name": "Creative Commons Attribution 4.0",
        "short_name": "CC BY 4.0",
        "text": "Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.\r\n\r\nNo additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.",
        "url": "https://creativecommons.org/licenses/by/4.0"
    },
    "keywords": [],
    "section": "Population Health Research Design",
    "is_remote": true,
    "remote_url": "https://escholarship.org/uc/item/07t4d7xv",
    "frozenauthors": [
        {
            "first_name": "Lisa",
            "middle_name": "",
            "last_name": "Calvocoressi",
            "name_suffix": "",
            "institution": "Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut",
            "department": "None"
        },
        {
            "first_name": "Jesse",
            "middle_name": "",
            "last_name": "Reynolds",
            "name_suffix": "",
            "institution": "Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut",
            "department": "None"
        },
        {
            "first_name": "Benjamin",
            "middle_name": "",
            "last_name": "Johnson",
            "name_suffix": "",
            "institution": "Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut.",
            "department": "None"
        },
        {
            "first_name": "Meghan",
            "middle_name": "M.",
            "last_name": "Warzoha",
            "name_suffix": "",
            "institution": "Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut",
            "department": "None"
        },
        {
            "first_name": "Megan",
            "middle_name": "",
            "last_name": "Carroll",
            "name_suffix": "",
            "institution": "Yale School of Medicine, Department of Emergency Medicine, New Haven, Connecticut",
            "department": "None"
        },
        {
            "first_name": "Federico",
            "middle_name": "E.",
            "last_name": "Vaca",
            "name_suffix": "",
            "institution": "Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, Maryland",
            "department": "None"
        },
        {
            "first_name": "Lori",
            "middle_name": "",
            "last_name": "Post",
            "name_suffix": "",
            "institution": "Northwestern University, Feinberg School of Medicine, Department of Emergency Medicine, Chicago, Illinois",
            "department": "None"
        },
        {
            "first_name": "James",
            "middle_name": "",
            "last_name": "Dziura",
            "name_suffix": "",
            "institution": "Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut\n\nYale School of Medicine, Department of Emergency Medicine, New Haven, Connecticut",
            "department": "None"
        }
    ],
    "date_submitted": "2019-06-13T19:53:25Z",
    "date_accepted": "2019-06-13T19:53:25Z",
    "date_published": "2020-02-24T21:43:27Z",
    "render_galley": null,
    "galleys": [
        {
            "label": "",
            "type": "pdf",
            "path": "https://journalpub.escholarship.org/westjem/article/12830/galley/6759/download/"
        }
    ]
}