The Finkelstein-Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power

Rong Tang; Wei-Chen Chen; Heng Li; Nelson Lu; Yu Zhao

doi:10.1007/s43441-023-00608-z

The Finkelstein-Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power

Ther Innov Regul Sci. 2024 May;58(3):465-472. doi: 10.1007/s43441-023-00608-z. Epub 2024 Feb 5.

Authors

Rong Tang¹, Wei-Chen Chen², Heng Li², Nelson Lu², Yu Zhao²

Affiliations

¹ Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. rong.tang@fda.hhs.gov.
² Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Abstract

In this note, we express our viewpoint regarding power considerations, via simulation studies, in clinical study design using hierarchical composite endpoint and Finkelstein-Schoenfeld test.

Keywords: Clinical trial; Composite endpoint; Correlation; Finkelstein–Schoenfeld; Study power; Time-to-event.

MeSH terms

Clinical Trials as Topic
Computer Simulation
Endpoint Determination
Humans
Models, Statistical
Research Design*