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Novel molecularly targeted agents (MTAs) have emerged as valuable alternatives or complements to traditional cytotoxic agents in the treatment of cancer. Clinicians are combining cytotoxic agents with MTAs in a single trial to achieve treatment synergism and better outcomes for patients. An important feature of such combinational trials is that, unlike the efficacy of the cytotoxic agent, that of...
The marker‐stratified design (MSD) is an important design to assess treatment and marker effects in personalized medicine. The MSD stratifies patients into marker positive and marker negative subgroups on the basis of their biomarker profiles and then randomizes them to the standard treatment or a new treatment within each subgroup. The performance of the MSD can be seriously undermined when the biomarker...
A traditional assumption in the design of chemotherapy phase I–II trial designs is that dose increases lead to both more toxicity as well as more efficacy. This assumption of monotonic rates of toxicity and efficacy has come into question as potential cancer treatments are less likely to be chemotherapy and are instead biologic agents. These biologic agents tend to have mechanisms of action that act...
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