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Clinical Studies Data Transparency Policy Lay Summaries of research results
 

Lay Summaries of research results

 

Patients are at the center of everything we do at UCB. Helping patients, caregivers, and the public understand the results of research is essential to that mission.


In 2014, UCB began posting lay summaries of clinical study results to our website. Currently, these summaries are posted for at least the pivotal and key studies of approved or withdrawn medicines. For each summary, we include feedback from a panel that includes a patient, caregiver, medical professional, lay expert, and member of the general public to make sure the summary is understandable.

 

UCB’s Policy for Lay Summaries is:

Current
Practice

UCB will post online the results in
plain language of all pivotal or key clinical studies of approved
compounds or indications.

Studies that begin after application
of EU Clinical Trial Regulation

UCB will post online the results in
plain language of all Phase 1-4 interventional clinical studies and observational studies.[1]

After application of the EU Clinical Trial Regulation, lay  summaries will be posted on our website:

 

Within 12 months after the study has ended, if the study included only participants 18 years old or older.

Within 6 months after the study has ended, if the study included any participants under 18 years old.

For observational studies[1], lay summaries will be posted online within 18 months of study completion.

 

After application of the EU Clinical Trial Regulation:

All summaries will be provided in English and all other languages in which the study was conducted.

For observational studies[1], all lay summaries will be provided in English and any other native language relevant to the countries in the study or database examined.

 

[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.