Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Companion Diagnostics clinical performance studies

CDx CPSs can be pro- or retro-spective, normally conducted at an accredited central laboratory. Prospective studies involve testing clinical samples collected during a clinical trial Retrospective studies involve testing clinical samples collected from patients for research purposes

The route to an approved CDx is a simultaneous one between Pharma sponsor and Diagnostic sponsor

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• The flow of a blinded clinical trial with two treatment arms, where the key processes for which assays might be utilised are highlighted. • The processes in blue are used for medical management decisions of trial subjects. • The processes in pink are likely not to impact the medical management of the trial subjects.

2. What assays used in clinical trials are considered IVDs under the IVDR?

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