The Statistical Issues and Challenges for Follow-On Companion Diagnostic Devices

• Activity Number: 406
• Type: Topic Contributed
• Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Meijuan Li*
• Companies: FDA
• Keywords: Follow -on companion diagnostic ; theraupeutic efficacy ; external comparison study ; clinical validation

Abstract

A follow-on companion diagnostic device is defined as having the same therapeutic indication as a FDA-approved companion diagnostic device (denoted as the comparator). Ideally, to support follow-on device's therapeutic indication, therapeutic efficacy should be assessed directly using representative patients from the targeted population of the follow-on device. However, such a requirement may be difficult or impractical to accomplish. For example, the manufacturer of a follow-on companion diagnostic device may not have a therapeutic partner to conduct a new clinical trial, or they may be lack of the patient samples from the original clinical trial where the comparator and therapeutic product were evaluated. As such, an external comparison study is often conducted to assess the concordance between the comparator and the follow-on device. Difficulty and challenges rises on how to extrapolate the agreements from an external comparison study to therapeutic efficacy particularly when no patient level data of the original clinical trial is accessible. In this talk, we will discuss the challenges and issues for the clinical validation of follow-on devices.