Publications by Category

Regulatory Science research conducted at the Center spans a wide range of topics and research disciplines. You can browse some of our work by the focus areas below, a full list of publications can also be seen at https://hmcrs.org/research/all-publications/.

Digital Medicine

Novel clinical trial designs supporting drug and device approval

Emerging considerations for cell and gene therapies

Pediatric drug and device development

Health policies and law in drug regulation

Real world evidence in the lifecycle approach to product evaluation

Biomarkers and surrogate markers in drug trials

Digital Medicine

Novel clinical trial designs supporting drug and device approval

Pediatric drug and device development

Health policies and law in drug regulation

Real world evidence in the lifecycle approach to product evaluation

Biomarkers and surrogate markers in drug trials