Module 14 2022

21/03/2022

Clinical Investigation Report

• All patients and devices that enter the clinical investigation should be accounted for in the clinical investigation final report • Exclusion from analysis, missing data & lost to follow-ups • Tables, Figures & Listings for primary and secondary variables and of key prognostic and demographic variables. • Post-Hoc analyses (to address new questions emerging from pre- defined analysis) • Statistical judgement for analysis, interpretation and presentation of results • Investigation statistician should be a member of study report team

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

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Medical Device Clinical Investigation challenges

• Medical Device studies face unique challenges compared to their pharmaceutical counterparts: • Inability to blind patient and/or practitioner • Absence of comparators and placebos except for “sham” • “Learning curve” effect for practitioners using new devices • Operator variability • Device trial design and selection of endpoints (often complex and/or subjective) • Malfunctions of device mechanisms

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

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