Statistical designs for traditional phase I dose-finding trials consider dose-limiting toxicity in the first cycle of treatment. In reality, patients often go through multiple cycles of treatment and ...
Murine Anti-GD2 Monoclonal Antibody 3F8 Combined With Granulocyte-Macrophage Colony-Stimulating Factor and 13-Cis-Retinoic Acid in High-Risk Patients With Stage 4 Neuroblastoma in First Remission We ...
How does your role change when you are part of an adaptive design or some other form of an innovative trial design? In a traditional design, you have fixed assumptions on treatment effect, variability ...
The US Food and Drug Administration (FDA) last week finalized guidance on adaptive clinical trial designs for drugs and biologics. The 33-page guidance, which finalizes a draft version released for ...