What Were They Thinking? Pharmacologic priors implicit in a choice of 3+3 dose-escalation design

David C. Norris

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arXiv · 2012.05301

What Were They Thinking? Pharmacologic priors implicit in a choice of 3+3 dose-escalation design

David C. Norris

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Abstract

If explicit, formal consideration of clinical pharmacology at all informs the design and conduct of modern oncology dose-finding trials, the designs themselves hardly attest to this. Yet in conducting a trial, investigators affirm that they hold reasonable expectations of participant safety - expectations that necessarily depend on beliefs about how certain pharmacologic parameters are distributed in the study population. Thus, these beliefs are implicit in a trial's presumed conformance to a community standard of safety, and may therefore to some extent be reverse-engineered from trial designs. For one popular form of dose-escalation trial design, I demonstrate here how this may be done.

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David C. Norris. 2020-12-09. What Were They Thinking? Pharmacologic priors implicit in a choice of 3+3 dose-escalation design. https://arxiv.org/abs/2012.05301

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