Sources of Clinical Data
How Do You Obtain Clinical Data?
For any evaluation, data serves as the fuel driving the process. Just like any other, Clinical Evaluations require a big source of clinical data.
Manufacturers often worry about how to obtain clinical data and what will be the source of the data? To answer that, there is more than one way to obtain the clinical data needed for the initial clinical evaluation.
Clinical Data Through Clinical Trials
Clinical data is essentially the safety and performance information generated from using a medical device. Clinical data may be collected through clinical investigations conducted with the respective medical device.
Clinical Data Through Public Sources
The second route involves the collection of relevant scientific literature relating to the
- Design,
- Intended purpose,
- Safety, and
- Performance.
Here the manufacturer can either use the equivalence pathway or collect new clinical data on their device. If the equivalence route is chosen, the data must demonstrate compliance to the relevant regulatory requirements, e.g., the General Safety and Performance Requirements (Annex I) under the EU MDR. In this route, manufacturers will be required to conduct a Post-Market Clinical Follow-up (PMCF) study, which confirms safety and performance following approval when the medical device is placed on the market or put into service. A PMCF study does not always need to be a clinical investigation. Other options exist. PMCF is embedded within the manufacturer's overall Post-Market Surveillance (PMS) plan.
If equivalence is not demonstrated or established, the manufacturer may collect clinical data by performing surveys, clinical investigations, or "big data" from hospital networks or registries if approved in other countries. A risk-based approach should be used to determine which options are best for specific devices considering the quality, quantity, clinical relevance, state of the art, and benefit-to-risk assessments.
Arguably, both routes - clinical investigation and clinical evaluation via literature must be used to prove a medical device's clinical safety and performance before a device may be placed on the market.
The end goal of the clinical evaluation is to assess the clinical data and ensure that the data conforms to national requirements, guidelines, and standards. Once this data has been acquired, the CER can be written, finalized, and signed off. The CER is an ongoing process of becoming compliant and staying up-to-date on products being placed on the market.
It is mandated that the clinical evaluation and all of its documentation be updated continuously when PMS information becomes available, especially if it changes the evaluation's conclusions.
Cut to the chase!
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