Can we establish best practice for publishing raw clinical trial data?

Assessment of the reliability of published articles is seriously impeded by incomplete reporting. Many research funding agencies now require open access to the results of research they have funded, and some also require that researchers make available the raw data generated from that research, in recognition of the numerous benefits associated with this level of transparency.

As previously reported, Trials and BMC Research Notes are working with the scientific community to encourage complete and transparent reporting of scientific research. A recent Genome Medicine editorial also highlighted the data-sharing debate in genomics.

Common issues encountered when considering raw clinical data for publication include patient privacy – unless explicit consent for publication is obtained – and ownership, but agreed policies on tackling these concerns do not appear to be addressed in the guidance or mandates currently established.

An editorial just published in Trials sets out the challenges and opportunities presented by publishing raw clinical trial data sets in journals. The authors encourage further debate in the community and propose next steps for journal editors and publishers, ethics committees, research-funding agencies and trialists for establishing best practice for publishing trial data.


Towards agreement on best practice for publishing raw clinical trial data
Iain Hrynaszkiewicz, Douglas G Altman
Trials 2009, 10:17 (18 March 2009)
[Abstract] [Provisional PDF]

Following a meeting of relevant members of the scientific community, which included representation from the BMJ, The Lancet, Wellcome Trust and National Research Ethics Service, it was agreed that an important step forwards would be widely agreeable guidance on preparing raw data for publication in journals. This is a challenge currently being undertaken by the Trials Editors.

As stated in the editorial, any members of the clinical trials community interested in participating in this journal’s initiative to establish best publication practice for trial data and/or would be interested in reviewing draft guidance, are encouraged to leave their comments or contact the editorial office.

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