Abstract
Early phase trials provide crucial information about new medicines that allow them to be taken forward into larger confirmatory studies. Paediatric early phase studies are becoming more common, particularly in...
Highlights
Phase trials provide crucial information about new medicines that allow them to be taken forward into larger confirmatory studies
We review one of the most commonly used model- based designs, the continual reassessment method
One key question is: ‘What level of toxicity is acceptable based on the expected benefits of treatment?’ The maximum tolerated dose (MTD) is defined as the dose expected to cause a degree of medically undesirable dose- limiting toxicity (DLT) in an acceptable specified proportion of participants
Summary
Phase trials provide crucial information about new medicines that allow them to be taken forward into larger confirmatory studies. Early phase dose-escalation trials use rule-b ased designs such as the 3+3 to guide dose decisions. A trial is considered to have a rule-b ased design if predefined rules are used to guide decisions to escalate, continue or de-e scalate based on the observed toxicities at the current dose.
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