When designing a clinical trial, there is usually some uncertainty about the variability of the primary outcome variable. This may lead to an unnecessarily high or inadequately low sample size. The internal pilot study approach uses data from patients recruited up to an interim stage to re-estimate
Sample Size Recalculation in Internal Pilot Study Designs: A Review
✍ Scribed by Tim Friede; Meinhard Kieser
- Publisher
- John Wiley and Sons
- Year
- 2006
- Tongue
- English
- Weight
- 180 KB
- Volume
- 48
- Category
- Article
- ISSN
- 0323-3847
No coin nor oath required. For personal study only.
✦ Synopsis
Abstract
The adequacy of sample size is important to clinical trials. In the planning phase of a trial, however, the investigators are often quite uncertain about the sizes of parameters which are needed for sample size calculations. A solution to this problem is mid‐course recalculation of the sample size during the ongoing trial. In internal pilot study designs, nuisance parameters are estimated on the basis of interim data and the sample size is adjusted accordingly. This review attempts to give an overview on the available methods. It is written not only for biometricians who are already familar with the the topic and wish to update their knowledge but also for users new to the subject. (© 2006 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)
📜 SIMILAR VOLUMES
The recent paper by Sandvik et al. proposes a method for determining the size of internal pilot studies in the case of two groups and continuous outcome variables. Their method could be slightly improved by taking into consideration follow-up time and accrual rate. The basic idea of their method is