Phase I and II trials may have different overall goals (i.e., demonstrating safety vs. efficacy), but the two both struggle with a major challenge in oncology study design: finding the right dose. Luckily, decades of data and innovations have given researchers the tools necessary to plan a successful dose-finding trial. Read on for a look at six of the most common dose-finding trial designs in oncology today.
Rules or Models?
When it comes to Phase I dose-finding trial designs, there are two major types that encompass more specific strategies: rule-based designs and model-based designs. Both of these types work from the fundamental assumption of monotonically increasing dose-toxicity and dose-activity relationships. As their name suggests, rule-based designs use dose escalation based on predetermined rules and algorithms. Rule-based designs include traditional 3+3 design, accelerated titration design and rolling six. By contrast, model-based designs incorporate dose escalation that is guided by a mathematical model. Commonly used model-based designs include the continual reassessment method (CRM), modified CRM and the Bayesian logistic regression model.