BIOS 6318 Clinical Trials and Survival AnalysisSpring 2011Homework 1 Solutions1.The initial dose is 0.1 mg. The subsequent doses are 0.2, 0.3, 0.4, and 0.5 mg. First, treat 3 patients with the new chemotherapy for colon cancer. If none shows unaccepted toxicity, then treat the 3 patients with the next dose level. If unaccepted toxicity is observed in at least 2 patients, then stop the trial. The previous dose is the MTD. If unaccepted toxicity is observed in 1 patient, then add 3 more patients into the trial. If there is no unaccepted toxicity in the additional 3 patients, then increase the dose level. Otherwise, the previous dose is the MTD.The patient’s age should be considered in the Phase I trials. Because 70 years old is too old, it is not recommendable to enroll the patient into the trial. Also, his heart problem medications may interfere with or bias the study results. It is not ethical to allow him to be part of the study and not treat his heart problem while the study is on-going.
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