高次元治療併用への部分順序継続的再評価方法の適用
Weishi Chen1, Li Liu2, Nolan A Wages2
1MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.
Abstract:
Recent years have seen increasing popularities in therapies that combines several drugs and/or schedules, which imposes great difficulties on the design of appropriate Phase I clinical trials. The Partial Ordering Continual Reassessment Method (POCRM), among others, is a popular design that can be easily adapted to those complex settings. However, the design is introduced and evaluated in the setting of the combination of two drugs, and the combination of more than two drugs has rarely been investigated. In particular, the specification of toxicity orderings has always been an essential part of the POCRM, which becomes more difficult in high-dimensional settings due to the combinatorially increasing nature of the number of possible orderings of combination/schedules. This article proposes a systematic approach to specify orderings based on asymptotic properties in the setting of the combination of more than two drugs. Large simulation studies show that this novel ordering specification method leads to better design performance both asymptotically and with finite sample sizes.
関連する概念動画
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Dosage Regimens: Partial Pharmacokinetic Parameters
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Dosage Regimen Designs: Nomograms and Tabulations
Strategies for Assessing and Addressing Confounding
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
Crossover Experiments
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.


