Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Bridging

• The CDx IVD final version for conformity assessment may differ from the clinical trial prototype CDx • Analytical and clinical performance evidence pertains to final CDx (although can refer to prototype CDx for scientific validity) • If data from clinical drug trials is to be extrapolated for purposes of performance evaluation - need bridging data for final CDx vs prototype CDx • Ideally use clinical trial baseline samples for bridging study • For targeted design, also need samples from subjects excluded from trial on BM status alone (i.e. need BM+ and BM- samples) • Need a pre-specified plan to handle missing data and address potential bias • Consider measurement trueness and uncertainty when designing bridging studies

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Some more considerations for drug and device developers

• Cut-off (if applicable) should be defined prior to clinical performance study/pivotal drug trial. If not optimal: • Risk to study patients • May be unable to demonstrate positive benefit-risk of drug • Central or local testing? • Implications of pre-screening • Retain clinical trial baseline samples (BM+ and BM-) for future bridging • Existing CE mark may not preclude IVDR requirements – new population, sample or drug

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