论文标题
他们在想什么？在3+3剂量升级设计中，药理学先验隐含
What Were They Thinking? Pharmacologic priors implicit in a choice of 3+3 dose-escalation design
论文作者
论文摘要
如果明确，对临床药理学的正式考虑完全可以为现代肿瘤学剂量调查试验的设计和行为提供信息，那么设计本身就几乎没有证明这一点。然而，在进行试验时，研究人员确认，他们对参与者安全的合理期望 - 预期必须取决于对研究人群中某些药理参数的分配方式的信念。因此，这些信念在试验的假定符合社区安全标准中是隐含的，因此可能在某种程度上与试验设计相反。对于一种流行的剂量降低试验设计形式，我在这里演示了如何做到这一点。
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.
