Responsible Research & Development
Bausch Health maintains comprehensive policies surrounding our research and development activities. These policies require all company-sponsored research to comply with applicable U.S. federal health care program and FDA requirements, including GCP, as well as all applicable local laws, regardless of where the research takes place. For our pharmaceutical products, we comply with PhRMA’s Principles on the Conduct of Clinical Studies. Our policies set forth the requirements for conducting company-sponsored clinical trials, including the roles of the investigator(s) and of the institutional review board or local ethics committee. These policies apply to our internal R&D programs as well as to all research activities that are outsourced to a contract research partner.
Our Chief Medical Officer is responsible for overseeing our clinical trial programs, and for ensuring trials are conducted ethically. We regularly monitor clinical trials, including outsourced trials, to ensure they adhere to our rigorous standards. We also maintain policies surrounding post-trial access to medicines and compassionate use of unapproved drugs and devices.
Policy on Access to Clinical Study Data
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. We are committed to the timely disclosure of data from clinical studies, other than Phase I studies, of our investigational or marketed products. We commit to reporting study results in an objective, accurate, balanced, and complete manner.
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.
- Phase 2 to Phase 4 studies conducted in the United States are posted on https://www.clinicaltrials.gov/, and Phase 1 to Phase 4 studies conducted in Europe are posted on https://www.clinicaltrialsregister.eu/ctr-search/search.
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.
Bausch Health began tracking data-sharing metrics in 2020. View details here.
Please click here to learn more about our Clinical Trials Policy.