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Clinical trials lawyer welcomes new reporting method

Publication of first Registered Report signals improvements in medical research reporting

25 August 2017

Clinical trials lawyer, Gene Matthews, who represented participants in the TGN1412 drug trial, has welcomed the publication of a new type of journal article, a Registered Report.

The Registered Report article is one where the journal publishes the clinical trial regardless of the outcome. This new approach to the publication of medical research follows concerns in recent years about the reliability of published research, in particular that studies could not be reproduced when the methods were repeated.

The Registered Report article is designed to combat the problems of publication bias, where some types of results are more attractive to scientific publishers than others.  

Whilst clinical trials showing a negative result are vital for medical research it has been estimated that 1 – 66% of clinical trials never report results, see Publication and reporting of clinical trial results: cross sectional analysis across academic medical centres BMJ 2016 253

Registered Reports also tackle the challenge of hidden outcome switching, when the design of the study, outcome measures and analysis plan, are altered by the researchers running the projects when the trials start to return negative results. 

Registered Reports will ensure that the journals are unaware of trial results when they make the decision about whether or not to publish the articles leading to a more equal number of positive and negative trials being published.  A two stage peer review process both before and after data is gathered will mean that researchers will have to stick to their protocol.  Researchers will also have to make any anonymised data available publicly as a condition of publication. 

BioMed Central is the first medical journal to accept Registered Reports.

Clinical trials lawyer Gene Matthews said:

“I welcome this development which builds on efforts to make studies more transparent.  Volunteers can feel that their involvement is of real benefit to society and science even if the trial is ultimately unsuccessful.  It should also help trials of unsuccessful drugs being unnecessarily replicated.” 

Information was correct at time of publishing. See terms and conditions for further details.

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