If you’re in the practice of conducting early phase clinical trials, you’ve probably heard that modern trial designs include a number of new methodologies. There’s CRM and BLRM, model-based methods versus rule-based methods, and a number of other developments that might affect your clinical strategy. Each of these methods affects operational, financial and regulatory objectives in unique ways.
As a part of this year’s Joint Statistical Meeting, Cytel statisticians created a primer to go along with a workshop for early phase clinical trial design.
In the primer you will find:
1. An overview of 3+3, CRM, BLRM and mTPI methods
2. A synopsis of basic concepts like Bayesian and frequentist statistics, models and rules, etc.
3. Reflections on regulatory considerations
4. Case studies and topical exercises with Cytel’s high-powered simulations
5. A solution guide for those with access to Cytel's East software