Transparency helps the Research and Development

Servier has research programs in 4 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 1^st January 2014. The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States is 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 are made available on this website.

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

We undertake to share with the public a lay summary. It will cover all interventional studies to test a medicine in patients ending after the 1^st 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 1^st 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.