Mixed experience but no changes in the forecast
Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially, although it may adjust to more explicitly address current areas of high-unmet medical need such as antibiotic resistance and cardiovascular disease.
Tracking adoption of risk assessment and RBM
Growing utilization but wide variation in approaches and impact
For all the talk about how risk-based monitoring (RBM) can improve efficiencies in clinical trial processes, the actual level of execution varies widely among sponsor companies, the industry lacks a uniform approach to the methodology and some organizations have not yet pursued alternatives to traditional monitoring strategies.