Integrative Data Science in Drug Safety Research: Experiences, Challenges, and Perspectives.

Pharmaceutical research and development largely depend on the quantity and quality of data that are available to support projects. The secondary use of data by means of collaborative and integrative approaches is yielding promising results in drug safety research. However, there are challenges that must be overcome in these integrative approaches, such as interoperability issues, intellectual property protection, and, in the case of clinical information, personal data safeguards. The OMOP common data model and the EHDEN and DARWIN EU platforms constitute successful examples of data sharing initiatives in the clinical domain, while the eTOX, eTRANSAFE, and VICT3R international projects are examples of corporate data sharing in toxicology research. The VICT3R project is using these shared data for generating virtual control groups to be applied in nonclinical drug safety assessment. Drug-related knowledge bases that integrate information from different sources also constitute useful tools in the drug safety domain.