Biomedical subjects

Tatsuru Matsushita

Publications and source records attributed to Tatsuru Matsushita.

2 recordsLinked to original sources

PubMed2003

Stopping clinical trials because of treatment ineffectiveness: a comparison of a futility design with a method of stochastic curtailment.

This paper introduces a simple futility design that allows a comparative clinical trial to be stopped due to lack of effect at any of a series of planned interim analyses. Stopping due to apparent benefit is not permitted. The design is for use when any positive claim should be based on the maximum sample size, for example to allow subgroup analyses or the evaluation of safety or secondary efficacy responses. A final frequentist analysis can be performed that is valid for the type of design employed. Here the design is described and its properties are presented. Its advantages and disadvantages relative to the use of stochastic curtailment are discussed.

Data Interpretation, Statistical↗

PubMed2003

Incorporating data received after a sequential trial has stopped into the final analysis: implementation and comparison of methods.

In a sequential clinical trial, accrual of data on patients often continues after the stopping criterion for the study has been met. This is termed "overrunning." Overrunning occurs mainly when the primary response from each patient is measured after some extended observation period. The objective of this article is to compare two methods of allowing for overrunning. In particular, simulation studies are reported that assess the two procedures in terms of how well they maintain the intended type I error rate. The effect on power resulting from the incorporation of "overrunning data" using the two procedures is evaluated.

Biometry↗