Not Reporting Results of a Clinical Trial Is Academic Misconduct
Authors: Joshua D. Wallach, Harlan M. Krumholz
Journal: Annals of Internal Medicine (2019)

Editorials20 August 2019Not Reporting Results of a Clinical Trial Is Academic MisconductJoshua D. Wallach, MS, PhD and Harlan M. Krumholz, MD, SMJoshua D. Wallach, MS, PhDYale School of Public Health and Yale School of Medicine, New Haven, Connecticut (J.D.W.) and Harlan M. Krumholz, MD, SMYale School of Medicine, Yale School of Public Health, and Yale–New Haven Hospital, New Haven, Connecticut (H.M.K.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-1273 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Failure to report the results of clinical trials threatens the public's trust in research and the integrity of the medical literature, and should be considered academic misconduct at the individual and institutional levels. According to the ethical principles for research outlined in the Declaration of Helsinki, researchers "have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports" (1). When participants volunteer to take part in clinical trials, and expose themselves to interventions with unknown safety and efficacy profiles, they have a tacit assumption, based ...References1. World Medical Association. WMA Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects. Accessed at www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects on 4 April 2019. Google Scholar2. Wallach JD, Gonsalves GS, Ross JS. Research, regulatory, and clinical decision-making: the importance of scientific integrity. J Clin Epidemiol. 2018;93:88-93. [PMID: 29042327] doi:10.1016/j.jclinepi.2017.08.021 CrossrefMedlineGoogle Scholar3. Zarin DA, Tse T, Williams RJ, et al. Trial reporting in ClinicalTrials.gov—the final rule. N Engl J Med. 2016;375:1998-2004. [PMID: 27635471] CrossrefMedlineGoogle Scholar4. Ross JS, Mulvey GK, Hines EM, et al. Trial publication after registration in ClinicalTrials.gov: a cross-sectional analysis. PLoS Med. 2009;6:e1000144. [PMID: 19901971] doi:10.1371/journal.pmed.1000144 CrossrefMedlineGoogle Scholar5. Ross JS, Tse T, Zarin DA, et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012;344:d7292. [PMID: 22214755] doi:10.1136/bmj.d7292 CrossrefMedlineGoogle Scholar6. Ross JS, Mocanu M, Lampropulos JF, et al. Time to publication among completed clinical trials [Letter]. JAMA Intern Med. 2013;173:825-8. [PMID: 23460252] doi:10.1001/jamainternmed.2013.136 CrossrefMedlineGoogle Scholar7. Chen R, Desai NR, Ross JS, et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ. 2016;352:i637. [PMID: 26888209] doi:10.1136/bmj.i637 CrossrefMedlineGoogle Scholar8. Jones CW, Handler L, Crowell KE, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013;347:f6104. [PMID: 24169943] doi:10.1136/bmj.f6104 CrossrefMedlineGoogle Scholar9. Phillips AT, Desai NR, Krumholz HM, et al. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials. 2017;18:333. [PMID: 28720112] doi:10.1186/s13063-017-2068-3 CrossrefMedlineGoogle Scholar10. 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. doi:10.7326/M19-0440 LinkGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Yale School of Public Health and Yale School of Medicine, New Haven, Connecticut (J.D.W.)Yale School of Medicine, Yale School of Public Health, and Yale–New Haven Hospital, New Haven, Connecticut (H.M.K.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-1273.Corresponding Author: Harlan M. Krumholz, MD, SM, 1 Church Street, Suite 200, New Haven, CT 06510; e-mail, harlan.[email protected]edu.Current Author Addresses: Dr. Wallach: 60 College Street, 4th Floor, Room 411, New Haven, CT 06510.Dr. Krumholz: 1 Church Street, Suite 200, New Haven, CT 06510.This article was published at Annals.org on 7 May 2019. 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 Cited byCharacteristics of available studies and dissemination of research using major clinical data sharing platformsToward more rigorous and informative nutritional epidemiology: The rational space between dismissal and defense of the status quoWhy an automated tracker finds poor sharing of clinical trial results for an academic sponsor: a bibliometric analysisReporting BiasesPublication Rates of Heart Failure Clinical Trials Remain LowLost Evidence From Registered Large Long-Unpublished Randomized Controlled TrialsFernando Rico-Villademoros, MD, PhDInformationEXCEL trial—medicine turned on its head!Clinical trial publication trends within neurologyEditor's Corner: Negative Trials and Tribulations 20 August 2019Volume 171, Issue 4Page: 293-294KeywordsClinical trial reportingClinical trialsComputed axial tomographyDisclosureFood and Drug AdministrationMotivationPrevention, policy, and public healthResearch ethicsSafetySafety studies ePublished: 7 May 2019 Issue Published: 20 August 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...