As clinical drug development becomes more complex and resource-intensive, the FDA’s recent draft guidance on the use of Bayesian statistical methods in clinical trials signals a move toward more ...
Biomarker-based clinical trials provide efficiencies during therapeutic development and form the foundation for precision medicine. These trials must generate information on both experimental ...
Despite the fact that almost any sample of patients with a particular disease is heterogeneous, most clinical trial designs ignore the possibility that treatment or dose effects may differ between ...