Policy on Access to Clinical Study Data
Bausch Health is focused on Our Vision to be a trusted health care partner. We support clinical study data transparency in order to serve participants, researchers and health care providers, and to advance scientific knowledge and improve patient care. When providing access to clinical trial information, we consider the importance of protecting patient privacy and maintaining incentives for future innovative data generation and research. We continue to evaluate, evolve and expand our data sharing commitment.
As required, Bausch Health registers sponsored clinical studies on registries before the study start or within 21 days after the study start date.
Results Reporting on Study Registries
- Summary results are posted on the registry(ies) where the study was registered.
Access to Clinical Study Data
- Qualified scientific researchers may request data from completed Bausch Health-sponsored clinical studies after a product has received regulatory approval in the countries where Bausch Health and/or its partners have licensing rights to market it. Qualified researchers interested in obtaining access to clinical study data may submit a detailed research proposal for Bausch Health to review and make a data access request via email@example.com. Bausch Health will reply by email to confirm that the request was received and to provide more details on what will be required for consideration of the request. The data access request will be reviewed by a committee of internal advisors to evaluate scientific merit, any applicable restrictions on disclosure that may prevent us from fulfilling the request and assess whether the planned research is aligned with our goal of advancing public health.
- In general, data
will be made available for request six months after the product receives
approval from the U.S. Food and Drug Administration or the European Medicines
Agency, or 18 months after trial completion date, whichever occurs latest.
Access to Clinical Study Reports (CSRs)
- Qualified researchers may also request full CSRs.
Data sharing metrics will be provided on an annual basis beginning with the year 2020.