BackgroundMany clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, “The Final Rule” (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations.MethodsWe conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a “University/Organization” in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis.ResultsEligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02–0.25). Because of non-response and social desirability, this could be a “best case” scenario.ConclusionsBefore the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.Electronic supplementary materialThe online version of this article (10.1186/s12916-018-1042-6) contains supplementary material, which is available to authorized users.

ObjectiveThis study examined the extent to which trials presented at major international medical conferences in 2016 consistently reported their study design, end points and results across conference abstracts, published article abstracts and press releases.DesignCross-sectional analysis of clinical trials presented at 12 major medical conferences in the USA in 2016. Conferences were identified from a list of the largest clinical research meetings aggregated by the Healthcare Convention and Exhibitors Association and were included if their abstracts were publicly available. From these conferences, all late-breaker clinical trials were included, as well as a random selection of all other clinical trials, such that the total sample included up to 25 trial abstracts per conference.Main outcome measuresFirst, it was determined if trials were registered and reported results in an International Committee of Medical Journal Editors-approved clinical trial registry. Second, it was determined if trial results were published in a peer-reviewed journal. Finally, information on trial media coverage and press releases was collected using LexisNexis. For all published trials, the consistency of reporting of the following characteristics was examined, through comparison of the trials’ conference and publication abstracts: primary efficacy endpoint definition, safety endpoint identification, sample size, follow-up period, primary end point effect size and characterisation of trial results. For all published abstracts with press releases, the characterisation of trial results across conference abstracts, press releases and publications was compared. Authors determined consistency of reporting when identical information was presented across abstracts and press releases. Primary analyses were descriptive; secondary analyses included χ2tests and multiple logistic regression.ResultsAmong 240 clinical trials presented at 12 major medical conferences, 208 (86.7%) were registered, 95 (39.6%) reported summary results in a registry and 177 (73.8%) were published; 82 (34.2%) were covered by the media and 68 (28.3%) had press releases. Among the 177 published trials, 171 (96.6%) reported the definition of primary efficacy endpoints consistently across conference and publication abstracts, whereas 96/128 (75.0%) consistently identified safety endpoints. There were 107/172 (62.2%) trials with consistent sample sizes across conference and publication abstracts, 101/137 (73.7%) that reported their follow-up periods consistently, 92/175 (52.6%) that described their effect sizes consistently and 157/175 (89.7%) that characterised their results consistently. Among the trials that were published and had press releases, 32/32 (100%) characterised their results consistently across conference abstracts, press releases and publication abstracts. No trial characteristics were associated with reporting primary efficacy end points consistently.ConclusionsFor clinical trials presented at major medical conferences, primary efficacy endpoint definitions were consistently reported and results were consistently characterised across conference abstracts, registry entries and publication abstracts; consistency rates were lower for sample sizes, follow-up periods, and effect size estimates.RegistrationThis study was registered at the Open Science Framework (https://doi.org/10.17605/OSF.IO/VGXZY).

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Introduction: 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. We also examined the volume of EM trials and their subspecialty areas. Methods: 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. Results: 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 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. Conclusion: 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. [West J Emerg Med. 2020;21(2)295-303.] and trauma care research through additional federal funding; 2) assessing research needs, gaps, and opportunities; and 3) encouraging academic medical centers to provide research time and facilities. 4-5 Those recommendations prompted roundtable

SIR WILLIAM JENNER, HONOURED PRESIDENT OF THIS LEARNED COLLEGE,-Before entering on the subject which now brings us here, I must ask you to accept my thanks for the distinction you have conferred on me in selecting me for the office I have the honour to fill today an honour, allow me to add, which carries with it a special gratification to myself, inasmuch as among the many distinctions conferred by this College on my grandfather, the late Dr. Henry Revell Reynolds, there was not one he prized more highly than that of having delivered, as he did, before the President and Fellows of thi-3 College, one hundred and eight years ago, the Harveian Oration. MR. PRESIDENT, FELLOWS OF THIS COLLEGE, AND GENTLEMEN,-Sir Thomas Browne has said, in one of his sadder moods, "Our fathers find their graves in our short memories, and sadly tell us how we may be buried in our survivors.......... The greater part must be content to be as though they had not been-to be found in the register of God, not in the memory of man." This is without doubt true, as he said, of the "greater part," but it is not true of all; for our meeting here today is an assertion that there is, at least, one who has not yet found his grave in our vanishing powers of recollection, but whose life, unburied, still breathes in the lives of living acting men. It is not of the sorrows and "unavailing tears" that were shed, nearly 230 years ago, over Harvey's grave, that it behoves me now to speak; but rather of the fact that although the knells of nearly three centuries have been tolled since he became a part of this College, yet that only last year, on Oct. 18th, our College repaired to his grave in Hempstead to do honour to his memory, and with gratitude and glad-I f ness to assert, as we do again today , that he still lives " in I f his survivors," and that, although 306 years have passed since Harvey's life began, he at the present hour is neither dead nor sleeping. I. Let me ask you, for a few moments, to think over that ' ' act of last year. It is not meet to call it a " ceremony " or , " performance,"for those words may have a doubtful meaning. It was a something done, and that with purpose. It was done with reverence and solemnity, and fitting formal circumstance. The like of it has not often been seen in this country. It was simple, but it told of much complex thought and feeling; it was grave, but it was not sad; it was official, but it was not heartless. It was unnecessary, but it was urgent; it was a duty to the remains of Harvey; but it was also an honour to ourselves. Its voice could not " provoke the silent dust," but its tone could stir the now living " ear" and heart, and quicken the still acting brain. A. One thing that this College did last year was to show regard for the bodily remains of Harvey. There was something of him, that neither painting nor bust could be, which it still wished to cherish. It would try to hold together yet longer the last remnants of what was once the medium through which he saw Nature, and by which he read many of her s...