New tools are needed to evaluate and predict the efficacy and safety of medical products. However, the development of such tools requires collaboration and effective data sharing. In this issue of Therapeutic Innovation & Regulatory Science, scientists from the Critical Path Institute (C-Path) discuss their experiences using patient-level data to facilitate innovation in drug development. We share our perspective on the issues discussed in the C-Path paper and offer suggestions on future efforts.
Keywords: Data sharing; Drug development; Predictive tools; Regulatory science; Safety biomarkers.