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Clinical Studies Data Transparency Policy Peer-Reviewed Publications
 

Peer-Reviewed Publications

UCB believes that publishing research results in scientific peer-reviewed journals puts data in context, avoids publication bias, and is beneficial to the scientific community, researchers, and ultimately benefits patients. Peer-review is an editorial process where independent scientific experts review the research for robustness and scientific value before being published.

UCB is committed to submitting the results of all clinical studies for publication, regardless of whether the results are positive or negative. UCB submits the information to journals that are specialized, which means the journals focus on specific health topics or types of disease.

Since 2014, UCB has adhered to the standards set out by the European Federation of Pharmaceutical Industries and Associations & Pharmaceutical Research and Manufacturers of America Principles for Responsible Clinical Trial Data Sharing, followed established guidelines in medical and scientific publishing including the International Committee of Medical Journal Editors Recommendations and Good Publication Practice 3.

 

UCB’s Policy for Peer-Reviewed Publications is:

Studies that begin after
31 March 2020

UCB will submit manuscripts of all Phase 2-4 interventional clinical and observational studies[1] to a peer-reviewed journal

Studies that begin after application
of EU Clinical Trial Regulation

UCB will submit manuscripts of all Phase 1-4 interventional clinical and observational studies[1] to a peer-reviewed journal

The manuscripts will be submitted 12-18 months after the study has ended.

For Phase 1 trials: Manuscripts will be submitted within 12-18 months after first marketing authorization in either EU or US or global termination of product development.

If publication does not occur within 18 months after study completion or first marketing authorization, an Extended Results Summary that provides more details about the research than a standard Study Report will be posted online.

[1] For this policy, observational studies refer to real-world evidence studies that compare the effectiveness or safety of two drugs (including at least one UCB product) using a hypothesis.