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.

Researchers can submit their request in the Vilvi platform. Clinical trial data include protocols, raw data and clinical study reports. We redact personal data to protect the patients’ privacy.

This commitment applies to completed interventional clinical trials in patients, sponsored by Servier and submitted to the US and/or EU Regulatory Authorities, for Marketing Authorization (MA) of new medicines or new indications approved after 1st January 2014. For products for which development has been terminated before any MA approval, we also share clinical trial data for interventional clinical trials in patients sponsored by Servier, with a first patient enrolled on or after 1st January 2004.

2 | We publish on a public registry all our interventional studies that test a medicine, in line with the respective regulatory requirements.

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

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

We undertake to share with the public a lay summary. for all our interventional studies published on a public registry.

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.