Other Talks in the Series: Adaptive Clinical Trial Design

Other Talks in the Series: The Risk of Bias in Randomized Clinical Trials

The Continual Reassessment Method (CRM) was published in 1990. It is the most frequently used model-based design in oncology. The assignment of doses is very similar to the up-and-down designs, in the sense that we can escalate, deescalate or repeat the dose for the next cohort of patients. Patients can be assigned one at a time or in groups. We need to specify the total sample size. It's usually 18-24, if we have maybe four dose levels or five. The dose assignment for the next cohort or the next patient is determined based on a parsimonious model. It is also referred to as the working model. In the initial escalation, sometimes this working model tells us to assign high doses right away. However, because of ethical constraints, we do not skip doses in the initial escalation. Escalation starts at the lowest dose level and then it goes to dose level 2, 3, and 4, etc...