MetaMedical™ Solutions Inc

More guidance needed to use RWE to support device approvals in EU

There is little to no guidance by the European Medicines Agency (EMA) regarding the advanced use of RWE such as external controls and virtual trials, said Dr Andreas Beust, CEO of German contract research organisation (CRO) GCP-Service International.

The use of RWE to inform medical device approval was discussed at the Outsourcing in Clinical Trials: Medical Devices Europe 2024 conference in Munich, Germany, on 30-31 January. More than 90 devices which included RWE as part of their regulatory submissions have been approved by the US Food and Drug Administration (FDA), said Aude Yulzari, clinical affairs manager at German MedTech Precisis.

Yulzari added that the use of RWE is most evident in rare disease indications, with some devices being approved by the FDA based on RWE without the need to conduct a pivotal trial. The only guidance the EMA has regarding the use of RWE is the 2021 vision statement on the use of real-world evidence in EU medicines regulation, said Beust.

In 2017, the FDA granted de novo approval to Vapotherm’s Precision Flow high-velocity nasal insufflation device. According to the agency, device approval was based on RWE from a paediatric population which was supplemented by the data from a prospective randomised trial performed for the adult population.

In addition to the adult trial, the sponsor utilised published literature studies for the neonate population, including a retrospective cohort study of pulmonary outcome data extracted from medical records in the Vermont Oxford Network database.

Beust noted that the use of RWE is limited by the lack of availability of homogenous and structured data as some of the information may be incomplete or missing. He also cautioned that the use of RWE can also lead to the introduction of various biases such as information bias, recall bias and detection bias.

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In addition, Beust highlighted that you can emulate the data and evidence quality of a randomised control trial (RCT) by using RWE if you establish a rigorous process to address the limitations of RWE. A 2020 RCT emulation study found that RWE can emulate an RCT where active comparators were used.

“Although we are not yet at the stage where RWE alone can support regulatory approval, it can be used to support and build up the clinical evidence for the device,” said Beust.

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