Highlights

  • The overwhelming majority of dose-escalation clinical trials use methods that seek a maximum tolerable dose, including rule-based methods like the 3+3, and model-based methods like continual reassessment method (CRM) and escalation with overdose control (EWOC)

  • We see that the phenomena we have described are broadly observed across most disease types

  • The observation remained that dose-limiting toxicity (DLT) curves commonly increased with dose whilst objective response (OR) curves were mostly invariant in dose

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Summary

Methods

We sought to identify a broad sample of manuscripts reporting recent dose-finding clinical trials in oncology. Concerning outcomes, we extracted the dose-levels administered, the number of patients evaluated at each, and the number of DLT and objective response events recorded at each. These outcomes are explained and justified . The relative strength of the Emax model is that it allows the event probability to plateau at a value less than 1 It contains as a special case the scenario reflected by logit models where the event probability tends to 1 as dose is increased. We used both maximum likelihood and Bayesian approaches to fit Emax models. Data processing was aided using tidyverse [148] packages, posterior samples were extracted using tidybayes [149], and plots were produced using ggplot2 [150]

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