The far side of investigation.
DOI:
https://doi.org/10.19230/jonnpr.1478Keywords:
Trials, ethicsAbstract
According to American law, the results of all clinical trials must be published within twelve months. The situation is that 50% of all clinical trials are not published. This is a major problem because it is not possible to progress adequately towards the discovery and development of new therapies if there is no transparency in the results. Powell Smith and Goldcare have developed a new informatics tool, the Trials Tracker, which identifies automatically all concluded clinical trials, determines which of them have not been published and makes statistics. This tool allows disclosing the sponsors that hide their negative results.
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References
Culebras JM. Dos malas noticias. JONNPR. 2016;1(4):123-124 123 DOI: 10.19230/jonnpr.2016.1.4.1017
Anna Powell-Smith, Ben Goldacre. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions [version 1; referees: 2 approved]. F1000Research 2016, 5:2629 Last updated: 06 JAN 2017
Schmucker C, Schell LK, Portalupi S, et al.: Extent of Non-Publication in Cohorts of Studies Approved by Research Ethics Committees or Included in Trial Registries. PLoS One. 2014; 9(12): e114023.
Joe Biden: Agencies don’t report clinical trials should lose funds. STAT. 2016. https://www.reddit.com/r/Health/comments/4qhqi9/joe_biden_agencies_dont_report_clinical_trials/
Song F, Parekh S, Hooper L, et al.: Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010; 14(8): iii,ix–xi, 1–193.
Patients endangered as law is ignored. STAT. 2015.
Slade E., H. Drysdale, B. Goldacre. "Discrepancies Between Prespecified and Reported Outcomes." BMJ 11 November 2015. http://www.bmj.com/content/351/bmj.h5627/rr-12
Weston, J., K. Dwan, D. Altman, M. Clarke, C. Gamble, S. Schroter, P. Williamson, and J. Kirkham. “Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ.” BMJ Open 2016;6:4 e010075 doi:10.1136/bmjopen-2015-010075; http://bmjopen.bmj.com/content/6/4/e010075
SmithKline Beecham. A multi-center, double-blind, placebo controlled study of paroxetine and imipramine in adolescents with unipolar major depression –acute phase, Final clinical report. www.gsk.com/media/389566/depression_329_full.pdf.
Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h4320 (Published 16 September 2015)
Barbui C, Furukawa TA, Cipriani A. Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials. CMAJ 2008;178(3):296-305
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