Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials: A Survey

Abstract

Letters20 August 2019Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials: A SurveyAthina Tatsioni, MD, Fotini B. Karassa, MD, Steven N. Goodman, MD, PhD, Deborah A. Zarin, MD, Daniele Fanelli, PhD, and John P.A. Ioannidis, MD, DScAthina Tatsioni, MDUniversity of Ioannina School of Health Sciences, Ioannina, Greece (A.T., F.B.K.)Search for more papers by this author, Fotini B. Karassa, MDUniversity of Ioannina School of Health Sciences, Ioannina, Greece (A.T., F.B.K.)Search for more papers by this author, Steven N. Goodman, MD, PhDStanford University, Stanford, California (S.N.G., J.P.I.)Search for more papers by this author, Deborah A. Zarin, MDBrigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.A.Z.)Search for more papers by this author, Daniele Fanelli, PhDLondon School of Economics and Political Science, London, United Kingdom (D.F.)Search for more papers by this author, and John P.A. Ioannidis, MD, DScStanford University, Stanford, California (S.N.G., J.P.I.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-0440 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: Empirical studies have demonstrated that many randomized controlled trials (RCTs) remain unpublished (1–3). Besides publication in journals, trial results also may be disseminated by posting on ClinicalTrials.gov, a public, searchable registry. Loss of information is most worrisome when the largest and thus potentially most informative trials both remain unpublished and lack posted results long after completion.Objective: To assess the largest preregistered RCTs that were still both unpublished and lacked reported results at ClinicalTrials.gov more than 46 months after completion. We evaluated whether these trials subsequently were published or posted any results. These studies are an important part of ...References1. Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 2008;5:e191. [PMID: 18816163] doi:10.1371/journal.pmed.00501911 CrossrefMedlineGoogle Scholar2. Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008;5:e217; discussion e217. [PMID: 19067477] doi:10.1371/journal.pmed.0050217 CrossrefMedlineGoogle Scholar3. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167-70. [PMID: 12775614] CrossrefMedlineGoogle Scholar4. Moher D, Naudet F, Cristea IA, Miedema F, Ioannidis JPA, Goodman SN. Assessing scientists for hiring, promotion, and tenure. 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[PMID: 29477251] doi:10.1016/S0140-6736(17)32802-7 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: University of Ioannina School of Health Sciences, Ioannina, Greece (A.T., F.B.K.)Stanford University, Stanford, California (S.N.G., J.P.I.)Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.A.Z.)London School of Economics and Political Science, London, United Kingdom (D.F.)See Also: Editorial comment (page 293).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-0440.Reproducible Research Statement: Study protocol: Not available (exploratory analysis). Statistical code: Not pertinent. Data set: Available from Dr. Ioannidis (e-mail, [email protected]edu).This article was published at Annals.org on 7 May 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoNot Reporting Results of a Clinical Trial Is Academic Misconduct Joshua D. Wallach and Harlan M. Krumholz Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials Fernando Rico-Villademoros Metrics Cited byNon-inferiority in cancer clinical trials was associated with more lenient margins and higher hypothesized outcome event ratesWhy an automated tracker finds poor sharing of clinical trial results for an academic sponsor: a bibliometric analysisPublication Rates of Heart Failure Clinical Trials Remain LowProportion of published primary health care protocols with published results in subsequent papers was decreasingRoom for improvement in clinical trials for rare diseasesLost Evidence From Registered Large Long-Unpublished Randomized Controlled TrialsFernando Rico-Villademoros, MD, PhDInformationEXCEL trial—medicine turned on its head!Clinical trials in the pandemic age: What is fit for purpose?Harms From Uninformative Clinical TrialsNot Reporting Results of a Clinical Trial Is Academic MisconductJoshua D. Wallach, MS, PhD and Harlan M. Krumholz, MD, SM 20 August 2019Volume 171, Issue 4Page: 300-301KeywordsAllergic diseasesCardiovascular diseasesClinical trialsDisclosureInformation retrievalInsomniaInterquartile rangeMotivationObstetrics and gynecology ePublished: 7 May 2019 Issue Published: 20 August 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

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