Clinical Trials Transparency

Transparency helps the Research and Development

Servier has research programs in 6 major fields of medicine. We are a major player in pharmaceutical research. We believe that our research should contribute to medical progress. It needs to be shared with external researchers. Sharing improves Research, Knowledge & Patient Care. This collaboration should be responsible and protect the patients’ rights. It is the key to successful data sharing. These principles drive our Transparency Policy on clinical data.

 

We think it is an important way forward to enhance global public health.

 

We share the results of our clinical studies publicly, whether the results are neutral, negative or positive. We share results and data in different ways.

1 | We give researchers access to clinical trial data on request.


They can apply on our Data Request Portal. Clinical trial data include protocols, raw data and clinical study reports. We redact personal data to protect the patients’ privacy. This commitment applies to all studies in patients submitted for new medicines (and new indications). The medicine should be approved in the EEA or US after the 1st January 2014. The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered for this commitment.

 2 | We publish on a public registry all our interventional studies in patients and their results since 2004.


We select registries that meet WHO criteria (EudraCT, Clinicaltrials.gov, ISRCTN…). We publish summaries of results on these registries. These will also be made available on this website.

 

3 | We share results of clinical trials in lay terms.


We undertake to share with the public a lay summary. It will cover all interventional studies in patients ending after the 1st January 2018. These lay summaries are in line with recommendations from Medicines Agencies and written in collaboration with Patient Associations.

 

4 | We publish our results in the scientific literature.


We publish the results of our studies (at least all phase 3 studies) in peer-reviewed scientific conferences and/or journals. We publish all results regardless of the study outcome. We submit articles within 18 months of the end of the study. This concerns all studies ending after the 1st January 2014.

 

5 | We adhere to the 5 transparency principles set out by the EFPIA.


We publicly certify that we have established policies and procedures to implement the EFPIA Data sharing principles. This public website means that our data transparency policy can be reviewed.

 

 6 | We comply with the international standards.


We adhere to the regulatory requirements in each country. Furthermore, we try to harmonize our Transparency policy on a global level.

 

7 | We share clinical reports.


We disclose clinical reports on this website when we use them to obtain a Centralised Marketing Authorization in Europe.

 

 

 

Glossary

US: United States

EEA:  European Economic Area

WHO: World Health Organization

EFPIA: European Federation of Pharmaceutical Industries and Associations

Servier is a member of

> What are EFPIA Principles for Responsible Clinical Trial Data-Sharing 

> How Servier meets or exceeds the EFPIA commitments

 

Servier studies are mainly registered on

> EudraCT

> Clinicaltrials.gov

> ISRCTN

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