As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more ...

Relationship between overall survival and progression-free survival for recent NCCTG glioblastoma multiforme trials. Consolidation reduced dose whole brain radiotherapy (rdWBRT) following methotrexate ...

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 ...

In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is ...

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 ...

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 ...

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 ...