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Clinical trials lawyer welcomes statement on sharing data

Gene Matthews has welcomed a call that data on clinical trials should be shared more widely

Drug trial injuries

12 February 2016

Clinical trials lawyer Gene Matthews, who acted for four drug trial volunteers injured in the Northwick Park drug trial, has welcomed a recent editorial in the New England Journal of Medicine on the importance of sharing data from clinical trials.

The International Committee of Medical   Journals Editors (ICMJE) stated in the editorial that it believes that there is an ethical obligation to share information from interventional clinical trials as participants in such trials are putting themselves at risk.

A recent clinical trial in France resulted in the death of one man, and the serious injury of a number of other participants in the trial of painkiller BIA 10-2474.

A number of organisations, including the Royal Statistical Society and the British Pharmaceutical Society, have called for the early release of data about the design of the trial.

The pharmaceutical company that commissioned the trial, Bial, has released only partial information about the drug trial, citing commercial confidentiality as a reason for the lack of full transparency about the trial.

The ICMJE has published recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals which propose that for publication of a clinical trial report in member journals authors would have to share with others the deidentified individual patient data (IPD) providing the basis of the results in the article no later than six months after publication.

The ICMJE also suggest that authors include a plan for data sharing as a component of clinical trial registration.

The ICMJE hope that the requirement for full transparency around clinical trials will have a positive effect on the way in which clinical trials are planned, conducted and reported.

Drug trial lawyer Gene Matthews said:

“ICMJE proposals should be warmly welcomed by the pharmaceutical, scientific and medical communities.  

“Participants in clinical trials put themselves forward to assist the safe development of new and important drugs – those individuals accept this risk on behalf of the wider community for the betterment of us all.  

“It is a betrayal of that agreement that the data generated, as result of those clinical trials, is not always made available to the wider scientific and medical community.  Responsible data-sharing   has the ability to prevent selective publication/ reporting of research outcomes and unnecessary duplication of research effort.  These proposals help to put the hopes and wishes of trial participants back at the centre of safe drug development.”

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