In this video interview, David Morton, PhD, director of biostatistics at Certara, reflects on the growing role of Bayesian ...

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 ...

As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more flexible, data-driven approaches that integrate prior knowledge, reduce sample ...

The primary goal of the trial was to optimize radiation therapy (RT) dose among three levels (low, standard, and high), given either with placebo (P) or an investigational agent (A), for treating ...

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 ...

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 ...

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 ...

Clinical trials have traditionally followed a fixed design, in which patient allocation to treatments is fixed throughout the trial and specified in the protocol. The primary goal of this static ...