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Nowadays, more and more clinical trials choose combinational agents as the intervention to achieve better therapeutic responses. However, dose-finding for combinational agents is much more complicated than single agent as the full order of combination dose toxicity is unknown. Therefore, regular phase I designs are not able to identify the maximum tolerated dose (MTD) of combinational agents. Motivated by such needs, plenty of novel phase I clinical trial designs for combinational agents were proposed. With so many available designs, research that compare their performances, explore parameters impacts, and provide recommendations is very limited. Therefore, we conducted a simulation study to evaluate multiple phase I designs that proposed to identify single MTD for combinational agents under various scenarios. We also explored influences of different design parameters. In the end, we summarized the pros and cons of each design, and provided a general guideline in design selection.
Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical and efficient. These benefits are achieved while preserving the integrity and validity of the trial, th
Observational studies are valuable for estimating the effects of various medical interventions, but are notoriously difficult to evaluate because the methods used in observational studies require many untestable assumptions. This lack of verifiabilit
Some years ago, Snapinn and Jiang[1] considered the interpretation and pitfalls of absolute versus relative treatment effect measures in analyses of time-to-event outcomes. Through specific examples and analytical considerations based solely on the e
In early clinical test evaluations the potential benefits of the introduction of a new technology into the healthcare system are assessed in the challenging situation of limited available empirical data. The aim of these evaluations is to provide add
Interval designs are a class of phase I trial designs for which the decision of dose assignment is determined by comparing the observed toxicity rate at the current dose with a prespecified (toxicity tolerance) interval. If the observed toxicity rate