New tool detects problematic trials before they distort evidence | Cochrane

Results reporting for clinical trials led by medical universities and university hospitals in the Nordic countries was often missing or delayed

Objective To systematically evaluate timely reporting of clinical trial results at medical universities and university hospitals in the Nordic countries. Study Design and Setting In this cross-sectional study, we included trials (regardless of intervention) registered in the EU Clinical Trials Registry and/or [ClinicalTrials.gov][1], completed 2016-2019, and led by a university with medical faculty or university hospital in Denmark, Finland, Iceland, Norway, or Sweden. We identified summary results posted at the trial registries, and conducted systematic manual searches for results publications (e.g., journal articles, preprints). We present proportions with 95% confidence intervals (CI), and medians with interquartile range (IQR). Protocol: <https://osf.io/wua3r> Results Among 2,113 included clinical trials, 1,638 (77.5%, 95%CI 75.9-79.2%) reported any results during our follow-up; 1,092 (51.7%, 95%CI 49.5-53.8%) reported any results within 2 years of the global completion date; and 42 (2%, 95%CI 1.5-2.7%) posted summary results in the registry within 1 year. Median time from global completion date to results reporting was 698 days (IQR 1,123). 856/1,681 (50.9%) of [ClinicalTrials.gov][1]-registrations were prospective. Denmark contributed approximately half of all trials. Reporting performance varied widely between institutions. Conclusion Missing and delayed results reporting of academically-led clinical trials is a pervasive problem in the Nordic countries. We relied on trial registry information, which can be incomplete. Institutions, funders, and policy makers need to support trial teams, ensure regulation adherence, and secure trial reporting before results are permanently lost. What is new? ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Protocols <https://osf.io/wua3r> ### Funding Statement CA reports funding for this project by the Knut and Alice Wallenberg Foundation through the Wallenberg Foundation Postdoctoral Scholarship Program at Stanford (KAW 2019.0561). The complete funding statement is available in the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Data on clinical trials were collected from publicly available databases: <https://clinicaltrials.gov/> and <https://eudract.ema.europa.eu/> I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced are available online at <https://zenodo.org/records/10091147> All code used for data processing available online at <https://github.com/cathrineaxfors/nordic-trial-reporting> <https://zenodo.org/records/10091147> <https://github.com/cathrineaxfors/nordic-trial-reporting> [1]: http://ClinicalTrials.gov

ISOQOL Seeks Co-Editor-in-Chief | ISOQOL

Research waste is still a scandal—an essay by Paul Glasziou and Iain Chalmers

Progress has been made towards reducing the 85% of wasted effort in medical research—and the huge amounts of money misspent and harm caused to patients—but there’s still a long way to go, say Paul Glasziou and Iain Chalmers In their history of the evolution of guidelines for reporting medical research, Doug Altman and Iveta Simera showed that poor design, conduct, and reporting of medical research have been concerns for over a century: “The quality of published papers is a fair reflection of the deficiencies of what is still the common type of clinical evidence. A little thought suffices to show that the greater part cannot be taken as serious evidence at all.”1 Indeed, more than 250 years ago, the Scottish doctor James Lind declared in the introduction to his review of reports on treating scurvy: “Before this subject could be set in a clear and proper light it was necessary to remove a great deal of rubbish.”2 Quantifying the extent of poor reporting of medical research seems not to have begun until 1966 (box). After assessing 295 publications in 10 “most frequently read” medical journals, Schor (a statistician) and Karten (a medical student) concluded: “In almost 73% of the reports . . . conclusions were drawn when the justification for these conclusions was invalid.”3 However, the title of their article, “Statistical evaluation of medical journal manuscripts,” was unlikely to ignite action among clinicians to deal with a situation that threatened their patients’ wellbeing. The wake-up call came 30 years later, in 1994, with an editorial in The BMJ by the journal’s chief statistical adviser, Doug Altman. He described as a scandal4 that “huge sums of money are spent annually on research that is seriously flawed through the use of inappropriate designs, unrepresentative samples, small samples, incorrect …

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