The BMJ now requires data sharing for all submitted trials

The BMJ has become the first general medical journal to require data sharing for all trials. This means trials will be considered for publication only if the authors agree to make the relevant anonymised patient-level data available on reasonable request.

The BMJ Acting Head of Research Elizabeth Loder announced the news in an editorial. She explained that it is an extension of a policy implemented in January 2013, which required data sharing for trials of drugs or devices “because many high-profile, serious allegations of selective or non-reporting of trial results related to such products”.

But according to Loder, growing experience and evidence have shown that reporting problems affect academic- and government-sponsored trials as well as those relating to the corporate sector. Furthermore, organisations such as the US Institute of Medicine (IOM), the World Health Organization (WHO) and the Nordic Trial Alliance have been encouraging data transparency for some time.

“Making anonymised patient-level data from clinical trials available for independent scrutiny allows other researchers to replicate key analyses, reduces the possibility that studies will be unnecessarily duplicated and maximises use of the information from trials — an important moral obligation to trial participants,” Loder wrote.

She acknowledged that an initial investment of time and money is needed to prepare trial data for sharing, “but after the first use there are few additional costs; in essence, the value of the data increases with each use”.