OneArmPhaseTwoStudy: An R Package for Planning, Conducting, and Analysing Single-Arm Phase II Studies

OneArmPhaseTwoStudy: An R Package for Planning, Conducting, and Analysing Single-Arm Phase II Studies

Blog Article

In clinical phase II studies, the efficacy of a promising therapy is tested in patients for the first time.Based on the results, it is decided whether the development programme should be stopped or whether the benefit-risk profile is promising enough to justify the initiation of large phase III studies.In oncology, phase II trials are commonly conducted as single-arm trials with planned interim analyses to allow for an early stopping for futility.The Fresh Fruit specification of an adequate study design that guarantees control of the type I and II error rates is a key task in the planning stage of such a trial.

A variety of statistical methods exists which can be used to optimise the planning and analysis of such studies.However, there are currently neither commercial nor non-commercial software tools available that support the practical application of these methods comprehensively.The R package OneArmPhaseTwoStudy was implemented to fill this gap.The package allows determining an adequate study design for the particular situation at hand as METHYL B-12 well as monitoring the progress of the study and evaluating the results with valid and efficient analyses methods.

This article describes the features of the R package and its application.