Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results

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Vyšlo v časopise: Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results. PLoS Med 12(4): e32767. doi:10.1371/journal.pmed.1001819
Kategorie: Essay
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001819

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Zdroje

1. World Health Organization. WHO Statement on Public Disclosure of Clinical Trial Results. Accessed 14 April 2015. http://www.who.int/ictrp/results/reporting

2. World Health Organization. International Clinical Trials Registry Platform (ICTRP). Accessed 18 February 2015. www.who.int/ictrp

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6. Schmucker C, Schell LK, Portalupi S, Oeller P, Cabrera L, Bassler D, et al. Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries. PLoS ONE. 2014 Dec 23;9(12):e114023. doi: 10.1371/journal.pone.0114023 25536072

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8. World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191–2194. doi: 10.1001/jama.2013.281053 24141714

9. Hudson KL, Collins FS. Sharing and reporting the results of clinical trials. JAMA. 2015 Jan 27;313(4):355–6. doi: 10.1001/jama.2014.10716 25408371

10. Chalmers I. Underreporting research is scientific misconduct. JAMA. 1990 Mar 9;263(10):1405–8. 2304220

11. Food and Drug Administration Amendments Act of 2007. Pub. L. No. 110–85, 121 Stat. 823 (September 27, 2007).

12. European Medicines Agency. Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014. Accessed 18 February 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/06/news_detail_002127.jsp&mid=WC0b01ac058004d5c1

13. International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals—updated December 2014. Accessed 10 March 2015. http://www.icmje.org/recommendations/

14. US National Institutes of Health. HHS and NIH take steps to enhance transparency of clinical trial results. Accessed 18 February 2015. http://www.nih.gov/news/health/nov2014/od-19.htm

15. GlaxoSmithKline. GSK Public policy positions: Public Disclosure of Clinical Research. Accessed 18 February 2015. http://www.gsk.com/media/280827/disclosure-of-clinical-trial-information-policy.pdf