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Clinical Studies Data Transparency Policy Study Reports and Synopses
 

Study Reports and Synopses

 

UCB prepares reports that describe the methods used and the results for each study after it ends. This report is called a Study Report. A brief summary is called a Synopsis. The reports are given to the government agencies that approve and monitor the development of new medicines in their region or country. The agencies use the information in these reports to help them decide if a drug can be approved for a specific therapeutic use.

In 2014, UCB began posting Study Report Synopses online for pivotal trials that began before 2004. UCB also began sharing results for Phase 2-4 interventional clinical trials that began after 01 January 2004 but had not already been shared in another forum such as a public registry.

UCB shares Study Report Synopses on our website for all Phase 1-4 interventional clinical studies in patients that were part of an approved marketing application since 01 January 2014.

 

UCB’s Policy for Disclosure of Study Reports and Synopses:

Studies that begin after
31 March 2020

UCB will post online study report synopses for observational studies[1] and full Study Reports of all Phase 2-4 interventional clinical, and observational studies.

Studies that begin after application
of EU Clinical Trial Regulation

UCB will post online Study Reports of all Phase 1-4 interventional clinical studies in patients and healthy volunteers, and observational studies[1]

Studies that are part of an EU or US marketing
submission after 31 March 2020

UCB will post online Study Report Synopses of Phase 1-4 interventional clinical studies in patients

 

Studies that are part of an EU or US marketing submission after the application of the EU Clinical Trial Regulation

UCB will post online Study Report Synopses of all Phase 1-4 interventional clinical studies in patients and healthy volunteers

Study Report and Study Report Synopses will be posted within 12 months after the study has ended and 30 days after marketing authorization in EU and US, or global discontinuation of development.


Study Reports and Study Report Synopses of observational studies[1] will be shared within 18 months after the study ends.

[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.