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.
