Photo by Kristian Brock on Unsplash
Do we expect the incidence of dose-limiting toxicity to increase as dose increases in dose-escalation clinical trials? Categorically, yes.
Do we expect efficacy to be greater at higher doses? Implicitly yes - it is a reqirement of MTD-seeking methods like 3+3 and CRM.
But how well are each of these assumptions borne out by the data in real clinical trials? These questions motivated us to collect dose-level outcomes from recent dose-escalation clinical trials in cancer.
The dataset is introduced in this post. Analyses of the data will be conducted in future posts.
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Kristian Brock
Statistical Consultant
I am a clinical trial methodology statistician that likes to use Bayesian statistics.