In January, European regulators will start publishing the clinical reports that underpin their decision-making.

The lowdown: The European Medicines Agency (EMA) has finalized its plans for publishing clinical trial reports, and will start making the data available on 1 January 2015. The agency had originally planned to start publishing this type of data in January 2014 but, after receiving more than 1,000 comments during a public consultation phase, it pushed its timeline back. In May this year, a revised draft policy came under heavy criticism from transparency advocacy groups for, among other things, proposing that investigators would only be able to review the trial data on a computer screen (printing, saving and downloading of the data would have been prohibited).

Although the final policy reverses this restriction, other concerns persist. Most notably, transparency advocates take issue with the fact that “commercially confidential information” may be redacted. “The policy puts primary responsibility for redacting information into the hands of trial sponsors,” writes the AllTrials campaign in a statement. “The EMA has a policy that the information in clinical trial reports should not generally be considered commercially confidential (this is echoed in the [European Union] Clinical Trials Regulation) but it may never become clear which information is being kept hidden.”

The EMA says it plans to make individual patient-level data available in the future.

Several companies — including Bayer, Boehringer Ingelheim, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Novartis, Roche and Sanofi — have already started making clinical data available through their own data-request portals.