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Sharing Data From Clinical Trials

An editorial from the International Committee of Medical Journal Editors (ICMJE) has been published simultaneously in 14 medical journals: Annals of Internal Medicine, The BMJ, Canadian Medical Association JournalChinese Medical JournalDeutsches Ärzteblatt (German Medical Journal), Ethiopian Journal of Health SciencesJAMA (Journal of the American Medical Association), Nederlands Tijdschrift voor Geneeskunde  (Dutch Medical Journal), New England Journal of MedicineNew Zealand Medical JournalPLoS MedicineRevista Médica de ChileThe Lancet, and Ugeskrift for Laeger (Danish Medical Journal).

In this editorial, the ICMJE authors write that it “is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.” For this reason, the editors plan to require that de-identified individual-patient data (IPD) is made publicly available no later than 6 months after publication of the trial results. This requirement will go into effect for studies that begin enrollment one year after the ICMJE adopts its data-sharing requirements. As soon as possible, authors will have to include a plan for data sharing as a component of clinical trial registration. The ICJME encourages feedback on the proposed requirements at www.icmje.org by 18 April 2016.

For those of us who are involved in meta-analysis and meta-science, the implications of this new editorial policy cannot be overstated. Medical research funders, reviewers involved in the Peer Reviewers' Openness Initiative and now editors are ready to make open science a standard. Industrial or academic sponsors, scientists, investigators, and indeed patients participating in the trial will have to be prepared for the changes. 

As was the case in 2005 with the introduction of the requirement for clinical trial registration, the scientific community will face numerous challenges arising from the transition to the new order of academic publishing. But, in comparison with the 2005 initiative, this proposal may have an even more significant impact on the way science is performed, reproduced and incentivized. In 2005, the field of clinical trials became more transparent. With this requirement, it will hopefully become collaborative. This is a dramatic cultural change that may encounter some barriers. It may also change the way we depend on authorship as the gold standard to reward clinical research. In this context, it will be important to ensure that the contributions of those clinicians who carefully collect the data will not be overlooked in this new “open world”.

This new editorial policy will not solve all problems of clinical research. For instance, it will not impact unpublished clinical trial data, which will still remain a huge barrier for claiming that science is now open. While this initiative represents an important step forward, the road towards full transparency is still long.

As these new requirements for publishing experimental findings come into effect, it will be necessary to assess whether they have the intended effects. Will these new requirements for openness allow science to progress faster and more reliably towards the truth?  At METRICS, we bet yes, and look forward to evaluating the impact empirically.