"Digital twin" is now applied to almost any model that predicts a patient's outcome. This latest blog separates three kinds of models and what each can replace in a clinical trial. In addition, we also make the case that virtual controls should provide a full predictive distribution for each patient rather than a single forecast.

Conventional clinical trials are stadiums built from scratch for a single contest and dismantled the moment it ends, which accounts for much of what they cost and how long they take. Platform and basket trials replace that pattern with a standing arena, and when the structure stays up the arithmetic changes for arms, sponsors, sites, regulators, and above all, patients.

In today's blog, Dr. Kert Viele discusses the recent oseltamivir results from REMAP-CAP, and the resulting social media critiques.

Not all interim analyses in clinical trials require alpha adjustment; penalties depend entirely on the pre-specified adaptive action, not the simple act of reviewing data.

In today's blog, Dr. Kert Viele breaks down the most crucial updates of the draft guidance on "Master Protocols for Drug and Biological Product Development," specifically focusing on the new details surrounding basket trials, control group requirements, and the heavy integration of the FDA's draft Bayesian guidance.

In this week's blog, Dr. Kert Viele discusses his thoughts on the RAR literature and the current state of RAR in practical clinical trials. He focuses on general principles that have emerged in the literature, the nuts and bolts of constructing and tuning RAR designs, and operational issues.