We aim to motivate wider use of model-based designs for dose finding, such as the continualreassessment method (CRM).
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These include continualreassessment of pain and risk, treatment agreements, compliance monitoring, urine drug screening, documentation, compliance with the law, and patient education.
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A continualreassessment approach with a straightforward dose selection criterion using the accumulated data from all patients treated to that point is employed.
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Dose escalation was based on the modified continualreassessment method (MCRM), with one patient treated at each minimally toxic dose level.
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The continualreassessment method is a recommended dose escalation design for including patients in phase I clinical trials designed to estimate the maximum tolerated dose.
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Part 1 uses a restricted 1-stage Bayesian continualreassessment method based on a target dose-limiting toxicity probability of 35%.
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Methods: An adaptive, two-stage continualreassessment trial was designed to evaluate the safety of regadenoson (A 2A R agonist) in the setting of lung transplantation.
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Model-based approaches proposed to identify the MTD (including the ContinualReassessment Method or CRM) suppose a simple model for the dose-toxicity relation.