使用 Prolog 实现的肿瘤学剂量递增方案的可执行规范
An Executable Specification of Oncology Dose-Escalation Protocols with Prolog
AI总结：
本文提出了首个以纯Prolog程序实现的3+3肿瘤剂量递增方案可执行规范，通过CLP(Z)约束的预期后悔场景推导操作，为试验前验证和在线决策提供稳健支持。
摘要：
我们以纯 Prolog 程序的形式，提出了早期肿瘤药物开发中常用的 3 + 3 剂量递增方案的第一个可执行规范。在该程序中，方案的命令式操作表现为被声明为 CLP(Z) 约束的、具有临床意义的预期后悔场景的结果。这种“后悔约束”（RC）规范产生了一个稳健的公式，它可用于在将方案纳入试验之前证明其具有临床意义的安全性和活性属性，并在试验进行期间作为在线决策支持系统使用。我们的 RC 规范还能轻松适应对试验入组的某些实用修改，而这些修改会严重制约传统的命令式公式。现代 Prolog 系统的特性使我们能够用一个简短且通用的程序来描述 3 + 3 方案，该程序具有理想的代数属性，因此可以通过多种不同方式被使用、测试和推理。
英文摘要：
We present, as a pure Prolog program, the first executable specification of the 3 + 3 dose-escalation protocol commonly used in early-phase oncology drug development. In this program, the imperative operations of the protocol emerge as consequences of clinically meaningful anticipatory-regret scenarios that are declared as CLP(Z) constraints. This 'regret-constrained' (RC) specification yields a robust formulation which can be used to prove clinically meaningful safety and liveness properties of the protocol before incorporating it into a trial, and then as an on-line decision support system while the trial is underway. Our RC specification also readily accommodates certain pragmatic modifications to trial enrollment which severely strain traditionally imperative formulations. The features of modern Prolog systems let us describe the 3 + 3 protocol with a short and general program that has desirable algebraic properties and can therefore be used, tested and reasoned about in several different ways.
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