Multiple Testing Approaches in Device Clinical Trials

• Activity Number: 624 - Trial Design and Analysis Issues in Medical Devices
• Type: Contributed
• Date/Time: Thursday, August 3, 2017 : 8:30 AM to 10:20 AM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Vandana Mukhi* and Heng Li
• Companies: FDA/CDRH and U. S. FDA
• Keywords: Superiority ; Non-inferiority ; Iterative graph ; labeling claim

Abstract

Clinical endpoints are an essential design component of a pivotal clinical investigation. Multiple primary and secondary endpoints are often considered to assess safety and effectiveness of a new device. In the context of multiple endpoints, we will discuss the testing of non-inferiority and superiority hypothesis, study success criteria and multiplicity adjustment approaches.