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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

New federal rules (US) target woeful public reporting of clinical trial results – STAT (Charles Piller September 2016)0

Posted by Admin in on October 27, 2016

WASHINGTON – Researchers will have to publicly report the results of many more clinical trials, including some for drugs and devices that never reach the market, under new government rules announced Friday.

The federal rules, which also require more complete reporting of deaths, clarify and strengthen a 2007 law that requires researchers to report results of many human studies of experimental treatments for ailments such as diabetes, cancer, and heart disease.

A STAT investigation last year found widespread noncompliance with reporting requirements by both drug companies and academic institutions — including universities that are among the top recipients of government research funding, and by National Institutes of Health staff scientists. In the vast majority of cases, study results were reported long after statutory deadlines or not at all.

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[Australian QLD case] Australian court finds Parkinson’s researcher guilty of fraud0

Posted by Admin in on October 24, 2016

A court in Brisbane, Australia, has found Parkinson’s researcher Caroline Barwood guilty of two charges of fraud and three counts of attempted fraud.

Barwood, 31, was formerly based at the University of Queensland (UQ). Released on bail in 2014, Barwood had originally pleaded not guilty to the charges. Yesterday, according to 9News, a jury found her guilty on the five counts, but not on two others.

She will be sentenced tomorrow.

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(Australian QLD case update) Parkinson’s researcher in Australia pleads not guilty to fraud – Retraction Watch (Dalmeet Singh Chawla, October)0

Posted by Admin in on October 18, 2016

Parkinson’s researcher Caroline Barwood pleaded not guilty to fraud-related charges in a Brisbane courtroom Monday.

According to 9News, Barwood is accused of three counts of fraud, and four instances of attempted fraud, which include trying to obtain approximately $700,000 (AUD) from various organizations between 2011 and 2013 for a study that never occurred. The case follows an investigation at her former institution, the University of Queensland (UQ), which resulted in three of her papers being retracted.

Crown Prosecutor Caroline Marco alleged that Barwood was also intimately involved with Bruce Murdoch, her former colleague at the UQ, who has pleaded guilty to 17-fraud related charges, and received a two-year suspended sentence earlier this year.

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The Importance – and the Complexities – of Data Sharing (Papers: Jeffrey M. Drazen, M.D. et al 2016)0

Posted by Admin in on October 14, 2016

We at the Journal are committed to making the sharing of clinical trial data an effective, efficient, and sustainable part of biomedical research. This issue of the Journal includes three Perspective articles on the topic of data sharing. Grossman et al. describe the Genomic Data Commons, which will initially house raw genomic data and diagnostic, histologic, and clinical outcome data from National Cancer Institute–funded projects.1 Lo and DeMets recommend steps for addressing clinical trialists’ primary reservations about sharing their data.2 And Rockhold et al. consider progress to date and a path forward that could avert the creation of a fragmented data-sharing landscape.3 In August 2016, we published four Perspective articles on the same topic — two by experts who favored rapid open access to clinical trial data and two by other experts who were more reserved in their enthusiasm, focusing on the hurdles to be overcome.4-7 With these articles, and with others to come, our goal is to bring to the table a wide variety of opinions about the value, risks, unknowns, and rewards that accompany data sharing in the context of clinical trials. We firmly believe that complex issues are best clarified through open discussion and the airing of various viewpoints. Only by seeing the issue through many sets of eyes can we achieve the clarity we need to move forward. We hope that you will read each of these pieces with this idea in mind. Our enemy is disease and the human toll it takes. We need to use every means possible to come closer to vanquishing the real foe.

Drazen JM, Morrissey S, Malina D, Hamel MB, and Campion EW (2016) The Importance – and the Complexities – of Data Sharing. New England Journal of Medicine. 375 pp1182-1183 DOI: 10.1056/NEJMe1611027
Publisher (Open Access):
Interview with Jeffrey Drazen: Listen | Download