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Optimal planning of adaptive two-stage designs.

Published version
Peer-reviewed

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Type

Article

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Abstract

Adaptive designs are playing an increasingly important role in the planning of clinical trials. While there exists various research on the optimal determination of a two-stage design, non-optimal versions still are frequently applied in clinical research. In this article, we strive to motivate the application of optimal adaptive designs and give guidance on how to determine them. It is demonstrated that optimizing a trial design with respect to particular objective criteria can have a substantial benefit over the application of conventional adaptive sample size recalculation rules. Furthermore, we show that in many practical situations, optimal group-sequential designs show an almost negligible performance loss compared to optimal adaptive designs. Finally, we illustrate how optimal designs can be tailored to specific operational requirements by customizing the underlying optimization problem.

Description

Funder: RUPRECHT KARLS UNIVERSITAET HEIDELBERG ‐ Projekt DEAL

Keywords

adaptive design, clinical trial, optimal design, sample size calculation, Research Design, Sample Size

Journal Title

Stat Med

Conference Name

Journal ISSN

0277-6715
1097-0258

Volume Title

40

Publisher

Wiley
Sponsorship
Deutsche Forschungsgemeinschaft (KI 708/4‐1, RA 2347/4‐1)