Kert Viele's blog discusses the FDA's draft guidance on master protocols for drug and biological product development, highlighting key sections on trial design, randomization, control groups, informed consent, and regulatory considerations, while encouraging feedback from experts to enhance the guidance's effectiveness before the comment deadline of February 22.

Join the Berry Consultants software team for their January FACTS webinar on January 19th at 11am EST to learn about the upcoming addition of an ordinal endpoint option to the trial simulator via Zoom at the provided link.

In this video we look at the different types of MAMS designs that includes Platform Trail designs. We look at the different design issues and analysis methods available for these sorts of trials. Originally aired November 9, 2023

The blog by Kert Viele discusses the potential biases in clinical trial results, particularly focusing on early stopping trials and the implications of only publishing successful outcomes, emphasizing that while biases exist, their significance varies based on the true response rate and the context of the trial.

In this video we look at designing Phase 2 Basket Trials where a treatment is explored in a large number of sub-groups (too many to be able to suitably power the trial in each sub-group).

In this video we look at designing seamless phase 2/3 trials, where a multi-arm phase 2 transitions when it can, selecting a dose and transitioning to a confirmatory phase 3.