Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials
Authors: Fernando Rico-Villademoros
Journal: Annals of Internal Medicine (2020)

Letters21 January 2020Lost Evidence From Registered Large Long-Unpublished Randomized Controlled TrialsFernando Rico-Villademoros, MD, PhDFernando Rico-Villademoros, MD, PhDInstitute of Neurosciences, University of Granada, Granada, Spain (F.R.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L19-0618 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Tatsioni and colleagues' article (1) calls attention to the problem of unpublished trials. For researchers, making all clinical trial results public is unavoidable in order to obtain a balanced view of the risks and benefits of interventions and thus allow for evidence-based decision making (2). Tatsioni and colleagues analyzed data from the 500 largest randomized registered clinical trials that were initiated after 1 June 2007, completed before 1 June 2012, and unpublished (defined as neither published nor posted on ClinicalTrials.gov) as of April 2016. After surveying these data until January 2019, they found that 67 trials involving ...References1. Tatsioni A, Karassa FB, Goodman SN, et al. Lost evidence from registered large long-unpublished randomized controlled trials: a survey. Ann Intern Med. 2019;171:300-1. [PMID: 31060046]. doi:10.7326/M19-0440 LinkGoogle Scholar2. Council for International Organizations of Medical Sciences; World Health Organization. International Ethical Guidelines for Health-related Research Involving Humans. 4th ed. Geneva: Council for International Organizations of Medical Sciences; 2016. Google Scholar3. Wallach JD, Krumholz HM. Not reporting results of a clinical trial is academic misconduct. Ann Intern Med. 2019;171:293-4 [PMID: 31060050] doi:10. LinkGoogle Scholar4. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. E6(R2) Good Clinical Practice: integrated addendum to ICH E6(R1). February 2018. Accessed at www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1 on 6 December 2019. Google Scholar Author, Article, and Disclosure InformationAffiliations: Institute of Neurosciences, University of Granada, Granada, Spain (F.R.)Disclosures: The author has disclosed no conflicts of interest. The form can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L19-0618. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoLost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials: A Survey Athina Tatsioni , Fotini B. Karassa , Steven N. Goodman , Deborah A. Zarin , Daniele Fanelli , and John P.A. Ioannidis Metrics 21 January 2020Volume 172, Issue 2Page: 165-166KeywordsBehaviorClinical trial reportingClinical trialsConflicts of interestDecision makingDisclosureResearch reporting guidelinesTreatment guidelines ePublished: 21 January 2020 Issue Published: 21 January 2020 Copyright & PermissionsCopyright © 2020 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...