The desire for RWD/RWE by global regulators to demonstrate medical device safety and efficacy is growing. We exist in an era of unprecedented technological capabilities for data linking, tokenization to protect privacy, and big data analytics. However, many challenges remain with the use of these data for medicines and device evaluation. Data quality, common data models, alignment on statistical methodologies, data linkage technology, data access and privacy, stakeholder agreements for data sharing, patient input and consent, and ethical concerns persist. Regulators must collaborate such that industry can leverage these capabilities in a least burdensome way and ensure RWE is used to effectively and efficiently get innovative medicines and technologies to patients around the world.
Read MoreRequirements for clinical evidence of medical device safety and performance are increasing globally. Not only in Europe, but in Australia and the United States. For devices that have already been on the market in the United States, you may have an option you hadn’t thought of: a retrospective observational research study. This option is particularly useful for implants, but can be used for any medical device used by or prescribed by a clinician in the United States. Simply put, you can tap into existing medical records to gather sufficient clinical evidence of the safety and efficacy of your device. You just have to make sure you do it the right way.
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