683:(EMA) and other national regulatory bodies outlined a shift in their stance on access to clinical trial data but also highlighted challenges that would need to be overcome. The regulators noted, "e consider it neither desirable nor realistic to maintain the status quo of limited availability of regulatory trials data" and concluded, "e welcome debate on these issues, and remain confident that satisfactory solutions can be found to make complete trial data available in a way that will be in the best interest of public health".
515:". The essay used a simulation approach to demonstrate that for most study designs and settings it is more likely for a research claim to be false than true due to inherent biases in the way that modern science is conducted. This paper has met much approval, though Goodman and Greenland criticized it in a short comment and a longer analysis. Ioannidis has answered this critique. A profile of Ioannidis' work including a discussion of his 2005 paper appeared in the November 2010 issue of
33:
195:
1954:
686:
The article marked a move towards the proactive disclosure of clinical trial data and led to the EMA holding a workshop to establish how this could be done. At the workshop Guido Rasi, the EMA's
Executive Director, announced "oday represents the first step in delivering our vision. We are not here to
580:
In July 2009, a United States federal court decision resulted in the release of approximately 1500 documents detailing how articles highlighting specific marketing messages written by unattributed writers, but "authored" by academics, are strategically placed in the medical literature – a practice
451:
From the outset the journal noted that it would not be part of "the cycle of dependency that has formed between journals and the pharmaceutical industry". The journal does not publish advertisements for pharmaceutical products or medical devices and the journal's open-access license means that it
555:
accepted it. The trial was stopped early by the Data and Safety
Monitoring Board who advised the investigators to interrupt the trial and offer circumcision to the control group. The trial estimated that male circumcision protected 60% (95% CI: 32%–76%) for female-to-male HIV transmission.
567:
subsequently issued recommendations concerning male circumcision and HIV/AIDS including suggestions for government strategic plans, advocacy challenges and exploring the role of new technologies for voluntary medical male circumcision (VMMC) such as
672:. The article outlined the need for access to all clinical trial data held by pharmaceutical companies and regulators, and detailed reasons given by Roche for not sharing data on Tamiflu.
599:
argued that sealed documents identified during the discovery process for the court case, which demonstrated the practice of ghostwriting, should be made available to the public.
444:
and has concentrated on publishing papers on diseases that take the greatest toll on health globally. In 2009 the journal reaffirmed its scope and noted that it would use an
572:
and other medical devices. Several
Ministries of Health along with key stakeholders have committed to scaling up VMMC for HIV prevention in Southern and Eastern Africa.
280:
165:
1668:
2078:
1244:
255:
1391:"Joint strategic action framework to accelerate the scale-up of voluntary medical male circumcision for HIV prevention in Eastern and Southern Africa"
251:
1390:
2088:
512:
1712:
880:
595:, acted as "intervenors" in litigation against menopausal hormone manufacturers by women who developed breast cancer while taking hormones.
622:(HT), to defend the unsupported cardiovascular "benefits" of HT, and to promote off-label, unproven uses of HT such as the prevention of
1690:
1262:
190:
614:
published the first academic analysis of the documents by
Adriane Fugh-Berman. Her article revealed that the pharmaceutical company
231:
1669:"European Medicines Agency – News and Events – European regulators propose way forward for publication of full clinical-trial data"
1141:
687:
decide if we will publish clinical-trial data, only how. We need to do this to rebuild trust and confidence in the whole system".
607:
724:
223:
219:
420:. The journal was published online and in a printed format until 2005 and is now only published online. The journal's acting
1168:
Auvert, Bertran; Taljaard, Dirk; Lagarde, Emmanuel; Sobngwi-Tambekou, Joëlle; Sitta, Rémi; Puren, Adrian (1 January 2005).
1775:
1290:"Achieving the HIV Prevention Impact of Voluntary Medical Male Circumcision: Lessons and Challenges for Managing Programs"
1541:
1170:"Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial"
1063:
434:
2093:
1064:"Assessing the unreliability of the medical literature: A response to "Why most published research findings are false""
901:
1797:
2083:
1847:
1341:"Voluntary Medical Male Circumcision: An Introduction to the Cost, Impact, and Challenges of Accelerated Scaling Up"
2042:
1248:
2103:
473:
40:
1825:
1910:
448:
to give highest priority to studies on diseases and risk factors that cause the greatest burden worldwide.
1263:"WHO and UNAIDS announce recommendations from expert consultation on male circumcision for HIV prevention"
432:
The journal's initial aim was to provide an open-access alternative to existing top-tier journals such as
272:
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2021:
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100:
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of 14.429, ranking it 7th out of 153 journals in the category "Medicine, General & Internal".
153:
445:
302:
296:
649:
627:
395:
858:
1568:"The imperative to share clinical study reports: recommendations from the Tamiflu experience"
1219:
1167:
846:
661:
243:
618:
used ghostwritten articles to mitigate the perceived risks of breast cancer associated with
563:(WHO) assessing the evidence for male circumcision to prevent HIV transmission. The WHO and
2014:
1266:
530:
508:
8:
1978:
1091:"Why Most Published Research Findings Are False: Author's Reply to Goodman and Greenland"
606:
website but they are now available as part of the Drug
Industry Documents Archive at the
582:
86:
1968:
1903:
1713:"European Medicines Agency: Workshop on access to clinical trial data and transparency"
1645:
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1757:
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1372:
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1245:"New data on male circumcision and HIV prevention: Policy and programme implications"
1201:
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1044:
993:
834:
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published an article by three researchers who were involved in ongoing updates of a
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is Clare Stone, who replaced the previous chief editor, Larry
Peiperl, in 2018.
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Eichler, H-G.; Abadie, E.; Breckenridge, A.; Leufkens, H.; Rasi, G. (2012).
913:
2000:
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1013:"Why Most Published Research Findings Are False: Problems in the Analysis"
347:
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1691:"EMA calls for open access to clinical trial data after Tamiflu concerns"
665:
630:, vision problems, and wrinkles. The article was subsequently covered by
379:
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112:
32:
502:
1066:. Johns Hopkins University, Department of Biostatistics. Archived from
539:
440:
390:. It began operation on October 19, 2004, as the second journal of the
1752:
1735:
1288:
Sgaier, Sema; Reed, Jason; Thomas, Anne; Njeuhmeli, Emmanuel (2014).
675:
In a commissioned perspective article published in the same issue of
657:
260:
2049:
1061:
623:
387:
45:
1339:
Hankins, Catherine; Forsythe, Steven; Njeuhmeli, Emmanuel (2011).
589:, represented by the public interest law firm Public Justice, and
318:
1798:"Workshop report: Access to clinical-trial data and transparency"
698:, was an invited speaker at the workshop representing the media.
465:
1736:"The new BMJ policy on sharing data from drug and device trials"
1826:"EMA workshop reveals divisions with industry . ecancer – News"
1491:"The haunting of medical journals: how ghostwriting sold "HRT""
935:"Journals Ranked by Impact: Medicine, General & Internal".
569:
564:
469:
531:
effect of male circumcision on female to male HIV transmission
1565:
639:
615:
204:
1142:"Lies, Damned Lies, and Medical Science – David H. Freedman"
602:
The documents were initially made publicly available on the
525:
Male
Circumcision for Reduction of HIV Infection Risk (2005)
559:
The results of this trial along with two others led to the
1619:"Open Clinical Trial Data for All? A View from Regulators"
660:, describing their experience of trying to gain access to
533:
was published in 2005 by
Bertran Auvert and colleagues in
1287:
800:
575:
1338:
1010:
1011:
Goodman, Steven; Greenland, Sander (1 January 2007).
803:"A Medical Journal for the World's Health Priorities"
503:
Why Most
Published Research Findings Are False (2005)
529:
The first randomized controlled trial to assess the
551:concerns around how the trial was conducted before
194:
746:
744:
742:
2070:
1855:Workshop on clinical-trial data and transparency
1776:"Roche offers compromise in Tamiflu data debate"
1733:
962:"Why Most Published Research Findings Are False"
1443:"Medical Papers by Ghostwriters Pushed Therapy"
2079:Creative Commons Attribution-licensed journals
1566:Doshi, P.; Jefferson, T.; Del Mar, C. (2012).
739:
513:Why Most Published Research Findings Are False
1918:
1904:
881:National Center for Biotechnology Information
714:
452:cannot benefit from exclusive reprint sales.
1062:Steven Goodman and Sander Greenland (2007).
507:In 2005 PLOS Medicine published an essay by
1820:
1818:
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455:
1911:
1897:
640:Tamiflu clinical trial data sharing (2012)
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1028:
987:
977:
959:
828:
818:
777:
767:
460:The journal is abstracted and indexed in
409:. To fund the journal, the publication's
407:Creative Commons "by-attribution" license
1815:
1542:"Medical ghostwriters who build a brand"
1539:
1139:
1089:Ioannidis, John P. A. (1 January 2007).
960:Ioannidis, John P. A. (1 January 2005).
801:The PLOS Medicine Editors (April 2009).
1393:. WhHO. 7 December 2011. Archived from
608:University of California, San Francisco
2071:
1440:
576:Wyeth Ghostwriting Scandal (2009/2010)
2089:Academic journals established in 2004
1892:
1140:Freedman, David H. (4 October 2010).
865:
1489:Fugh-Berman, AJ (7 September 2010).
1265:. WHO. 28 March 2007. Archived from
752:"Prescription for a Healthy Journal"
130:Creative Commons Attribution License
1540:Goldacre, Ben (18 September 2010).
1220:"Global bioethics blog: March 2012"
906:Intellectual Property & Science
497:
435:The New England Journal of Medicine
13:
928:
894:
727:from the original on 1 August 2012
386:covering the full spectrum of the
14:
2115:
1873:
1470:. Drug Industry Documents Archive
1441:Singer, Natasha (5 August 2009).
427:
2043:PLOS Neglected Tropical Diseases
1952:
193:
31:
1840:
1828:. Ecancer.org. 20 December 2012
1790:
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1734:Godlee, F.; Groves, T. (2012).
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668:) from the drug's manufacturer
547:rejected this paper because of
474:Science Citation Index Expanded
1055:
1004:
953:
794:
715:David Knutson (23 July 2012).
708:
585:. To release these documents,
1:
938:2014 Journal Citation Reports
723:. Public Library of Science.
701:
1636:10.1371/journal.pmed.1001202
1585:10.1371/journal.pmed.1001201
1508:10.1371/journal.pmed.1000335
1417:"Wyeth Ghostwriting Archive"
1358:10.1371/journal.pmed.1001127
1307:10.1371/journal.pmed.1001641
1187:10.1371/journal.pmed.0020298
1108:10.1371/journal.pmed.0040215
1030:10.1371/journal.pmed.0040168
979:10.1371/journal.pmed.0020124
820:10.1371/journal.pmed.1000072
769:10.1371/journal.pmed.0010022
413:requires in most cases that
7:
1857:. European Medicines Agency
1803:. European Medicines Agency
1224:globalbioethics.blogspot.ie
664:for the antiviral Tamiflu (
10:
2120:
2022:PLOS Computational Biology
1778:. PMLiVE. 26 November 2012
762:(1): e22. 1 January 2004.
620:menopausal hormone therapy
2094:English-language journals
1992:
1961:
1950:
1926:
1920:Public Library of Science
1715:. UKRIO. 18 December 2012
681:European Medicines Agency
561:World Health Organization
490:, the journal had a 2014
392:Public Library of Science
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2084:General medical journals
656:inhibitors for treating
487:Journal Citation Reports
480:/Clinical Medicine, and
456:Abstracting and indexing
1693:. PMLiVE. 11 April 2012
446:evidence-based approach
405:is published under the
2104:PLOS academic journals
679:, regulators from the
662:clinical study reports
650:Cochrane Collaboration
150:Standard abbreviations
1848:"Speaker biographies"
1247:. WHO. Archived from
902:"Master Journal List"
399:open access publisher
2015:PLOS Clinical Trials
945:(Science ed.).
916:on 26 September 2017
509:John P. A. Ioannidis
1979:Elizabeth Marincola
1468:"About the Project"
628:Parkinson's disease
484:. According to the
73:Publication details
27:
1969:Michael W. Carroll
1447:The New York Times
1397:on 11 January 2012
1251:on 8 October 2008.
857:has generic name (
592:The New York Times
21:
2066:
2065:
1753:10.1136/bmj.e7888
401:. All content in
372:(formerly styled
365:
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1955:
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1934:Patrick O. Brown
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1882:Official website
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1269:on 13 April 2007
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498:Notable articles
478:Current Contents
418:publication fees
388:medical sciences
348:Journal homepage
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1671:. Ema.europa.eu
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1629:(4): e1001202.
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1578:(4): e1001201.
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1070:on 6 April 2012
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717:"New PLOS look"
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545:medical journal
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