We believe that the sharing of information related to company sponsored clinical trials is central to our mission. The sharing of clinical trial information enables the medical and scientific community to further develop the medical and scientific knowledge base and permits the public to make informed healthcare decisions. It is also one of the best ways to inform prescribers and patients about scientific findings relating to our medicines.
Since January 1, 2014 we are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with:
(a) safeguarding the privacy of patients;
(b) respecting the integrity of national regulatory systems; and
(c) maintaining incentives for investment in biomedical research.
3.1 Clinical investigator access to data and review of results
We value the significant contribution of each clinical investigator, without whom advancements in medical science would not be possible. We seek to provide our investigators access to clinical data from the studies in which they participate.
- Individual investigators in multi-site clinical trials will have their own research participants’ data, and will be provided with the randomization code after conclusion of the trial.
- We will provide a summary of the study results to the investigators.
- Any investigator who participated in the conduct of a multi-site clinical trial will be able to review data for the entire study at the sponsor’s facilities, or other mutually agreeable location in response to a reasonable scientific inquiry.
- Investigators who are authors of study-related manuscripts will be given study data as needed to support the publication.
3.2 Information shared with external independent researchers
We share trial protocols, anonymized or pseudonymized patient level data and redacted clinical trial reports with qualified scientific and medical researchers. This is done upon researchers’ request, following approval of a new product or a new indication for products approved in both the EU and the US after January 1, 2014. Data will not be shared with competitors.
Such requests must be submitted in writing to the company’s portal and will be internally reviewed regarding criteria for researcher qualifications and legitimacy of the research purpose.
A summary of our “Responsible Data Sharing Policy for Researchers” and instructions for requesting data are outlined here.
3.3 Publishing clinical study report synopses
The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration, European Medicines Agency, or national authorities of EU member states after January 1, 2014 will be made publicly available upon the approval of a new medicine or new indication. All synopses disclosed under our commitment shall respect patient privacy, as well as third party agreements, and shall be redacted of all confidential commercial information.