Module 18 2021

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2/9/2021

2.Data evaluation: weighting • The relative contribution of each study should be weighted, taking into account: • Type of study: design & rigour • Completeness of information • Statistical validity • Risk of bias or misinterpretation of results by the authors • Relevance of: - study population

Appendix A6 of MedDev 2.7/1 rev 4 provides further information regarding studies that lack scientific validity for demonstration of clinical safety or performance.

- Intervention / device - outcome measures • Compliance with GCP / EN ISO 14155

3 – Analysis of data

• Meta-analysis: is it acceptable to combine results? • Questions to consider: • Were the populations of the different studies similar? • Were the same devices evaluated by the individual studies? • Was the treatment delivered in the same way, over the same period of time? • Were the study designs similar? • Were the same outcomes being evaluated, and were they reported in the same way? • Were the results of all included studies clearly explained? • Were the results of the different studies similar? If not, were reasons for variations explored?

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