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Drug trial protocol redactions by industry sponsors exposed

January 26, 2018

New research published by the Journal of the Royal Society of Medicine exposes the extent of redactions in protocols for industry-sponsored randomised drug trials. Trial protocols are needed for a proper assessment of the veracity of drug trial reports. The researchers, from the Nordic Cochrane Centre in Copenhagen, found widespread redactions in the protocols for commercially sponsored trials they received from research ethics committees in Denmark. The study is believed to be the first systematic assessment of which information in trial protocols pharmaceutical companies do not wish to disclose to independent researchers.

Professor Peter Gøtzsche, director of the Nordic Cochrane Centre, said: "We wished to compare the information in the protocols with the information provided to the patients in order to evaluate whether the trials were ethical and necessary and whether essential information about the benefits and the harms of the drugs had been hidden from the patients."

It is difficult to get access to drug trial protocols so Professor Gøtzsche and his colleagues used the Danish Freedom of Information Act to request access to 78 trial protocols approved by a research ethics committee from October 2012 to March 2013. Eight protocols were excluded because they did not meet the research inclusion criteria. Only 17 of 34 protocols for commercially sponsored trials were unredacted, compared to 34 of 36 non-commercially sponsored trials.

The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials. These include the definition of patient outcomes, the detection and analysis of adverse events and the sponsor's access to incoming data while the study is running.

Professor Gøtzsche said: "The amount of redactions in the protocols we received was so vast that it made them rather useless for assessing the ethical justification for the studies and to identify discrepancies with subsequent publications.

"We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data."
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Notes to editors

Redactions in protocols for drug trials: What industry sponsors concealed (DOI: 10.1177/0141076817750554) by Mikkel Marquardsen, Michelle Ogden and Peter C. Gøtzsche, will be published the Journal of the Royal Society of Medicine at 00:05 hrs (UK time) on Friday 26 January 2018.

The link for the paper when published will be:

http://journals.sagepub.com/doi/full/10.1177/0141076817750554

For further information or a copy of the paper please contact:

Rosalind Dewar
Media Office, Royal Society of Medicine
DL: +44 (0) 1580 764713
M: +44 (0) 7785 182732
media@rsm.ac.uk

For interviews, contact Prof. Peter C Gøtzsche, pcg@cochrane.dk or +45 53 64 20 66

The Journal of the Royal Society of Medicine (JRSM) is a leading voice in the UK and internationally for medicine and healthcare. Published continuously since 1809, JRSM features scholarly comment and clinical research. JRSM is editorially independent from the Royal Society of Medicine, and its editor is Dr Kamran Abbasi.

JRSM is a journal of the Royal Society of Medicine and it is published by Sage Publishing.

Sara Miller McCune founded SAGE Publishing in 1965 to support the dissemination of usable knowledge and educate a global community. SAGE is a leading international provider of innovative, high-quality content publishing more than 1000 journals and over 800 new books each year, spanning a wide range of subject areas. A growing selection of library products includes archives, data, case studies and video. SAGE remains majority owned by our founder and after her lifetime will become owned by a charitable trust that secures the company's continued independence. Principal offices are located in Los Angeles, London, New Delhi, Singapore, Washington DC and Melbourne. http://www.sagepublishing.com

SAGE

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