Category: Blog
Designing a Collection of Trials
Kert Viele @KertViele Introduction We conduct clinical trials to find effective treatments. Much...
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Hypothesis testing, clinically important effects, and do we pay too much for clinical trial insurance?
@KertViele Highly powered clinical trials are expensive. The sample sizes involved are a sum of...
Read MoreImproving Program Results Through Better Phase 1 and 2 Trials
Kert Viele (With thanks to Jeff Wetherington, Helen Zhou, Anna McGlothlin, and Liz Krachey) You are starting a development program. While currently unknown to you, your novel therapy is effective, at least at the right dose. In...
Read MoreWhen should you borrow historical data (or real-world evidence)?
Kert Viele and Christina Saunders @KertViele My colleague Scott Berry recently presented a webinar on historical borrowing. Webinar #5: Historical Borrowing in Clinical Trials This blog post doesn’t require you to have seen it,...
Read MoreHow to get control? Concurrent vs Contemporary vs Historical vs Synthetic controls
Real world evidence is everywhere these days, bolstered primarily by the FDA motivated discussion of including real world evidence as a supplement or complete replacement of control arms in clinical trials (e.g. synthetic...
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