Module 14 2022

21/03/2022

Controls & Randomization

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

15

Use and selection of controls

• The group in a study that does not receive the intervention and is used as a benchmark to measure the results of the group that does. • QUIZ QUESTION: In which cases is a control group necessary? • Where endpoints can be measured objectively, e.g. from radiological examination • Where the endpoints are subjective, e.g. improvement in pain • If comparison with an alternative/no intervention is intended • If safety and/or performance of the device is evaluated through the comparison of differences between treated patients and control group

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

16

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