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 ...

In the announcement, FDA Commissioner Mackary said, “Bayesian methodologies help address two of the biggest problems of drug development: high costs and long timelines. Providing clarity around modern ...

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 ...

Join the RAPS Twin Cities Chapter for an engaging and practical session focused on understanding clinical study design and statistics as they apply to medical device regulatory strategy. This session ...

Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale ...