Hello everyone! I'm Todd Graves and I joined Berry Consultants in January 2012. I hope to start blogging regularly on the Innovative Statisticians blog. I've designed several interesting trials and I'll talk about some of the statistical ideas in future blog posts. For a little foreshadowing, these are some of the trials I've helped design:
— A dose-finding Phase II design with crossover aspects to deal with patient heterogeneity, looking ahead to a potential Phase III trial without crossover;
— A Phase II trial aiming to optimize both dose and duration of treatment, and attempting to find the right population that benefits from treatment ("population enrichment"). The enriched population may consist of subjects with a range of disease severities and/or a range of times before start of treatment. Needless to say, it is challenging to do all these things simultaneously.
— A seamless Phase II-III trial where the first stage enriches the target population with respect to disease severity and the second stage enrolls only patients in the enriched population. The effect of disease severity is modeled nonparametrically, even in the registration analysis, which is Bayesian. Decisions are made based on the predictive probability of success in the registration analysis.
— A seamless II-III trial with dose finding in the first stage and with a composite endpoint and a nonparametric registration analysis. Again, decisions within the trial are made based on the predictive probability of success in the confirmatory analysis.
The fact that I've mentioning these designs in no way implies any endorsement by regulators!
Along with designing innovative clinical trials, I have an interest in automatic rating college football teams, and in fact I've created a system that is based on a statistical model for the entire history of the scores of games (not just the final score). Since the season has started, I will be updating the ratings weekly and announcing the new ratings here on this blog and posting them on the Berry Consultants website. More to come soon!
Thanks for listening- Todd