This article reviews the scope, key principles, methodological expectations, and regulatory implications of ICH E20, and ...

We review Bayesian and Bayesian decision theoretic approaches to subgroup analysis and applications to subgroup-based adaptive clinical trial designs. Subgroup analysis refers to inference about ...

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 ...

How can you design and execute early phase trials to get the results needed with limited resources and time? We need to balance what we can do and the resources we have with what needs to be done for ...

It's no secret that developing a new drug or medical device is an expensive and time-consuming endeavor. Often, despite the best efforts of those involved, traditional clinical trials end up wasting ...

Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents This study reviewed all industry-sponsored phase I clinical trial protocols ...

“Our clinicians engage in research now. It’s the usual care of the patient, and we generate research information from it.” —Louis Fiore, VA Boston Healthcare System The workshop session on innovations ...

Adaptive clinical trials are transforming how new treatments are tested, offering flexibility to modify studies based on interim data without compromising integrity. Regulators like the FDA, ICH, and ...