Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Stratified design

• Study inclusion not dependent on biomarker (BM) status Randomisation is stratified by BM status • Measures capacity of the BM to separate patients into those more likely or less likely to respond • Evidence of clinical validity of BM  Evidence of clinical performance of CDx IVD •

The Organisation for Professionals in Regulatory Affairs

19

Targeted (enriched design)

• Study inclusion is dependent on BM status • Need biological plausibility and prior evidence (non-clinical or clinical) that drug response likely to be dependent on BM status • Evidence of drug safety and efficacy in the presence (or absence) of the BM • No evidence of clinical validation of BM  Evidence of clinical performance of CDx IVD

The Organisation for Professionals in Regulatory Affairs

20

10