Despite stringent European Union (EU) laws governing smaller medical device and pharma companies, the DACH region can be an attractive place to conduct clinical trials, according to industry leaders.
EU regulations for clinical trials vis-à-vis other regulators were at the centre of a panel discussion at the ongoing 7th Annual Outsourcing in Clinical Trials DACH 2024, which is taking place in Zurich, Switzerland, on 29–30 October. The group discussed the advantages and challenges of conducting clinical trials in the DACH region, which covers Germany, Austria, and Switzerland.
Andrea Sauerland, senior vice-president of clinical operations at medtech company Endotronix said that the new medical device regulation (MDR) requirements in Europe are not promoting innovative trial design for medical devices and putting pressure on smaller companies.
The EU introduced its Medical Device Regulation (MDR) in 2017, an update to the 1992 Medical Devices Directive (MDD). MDR is intended to close gaps in the previous regulation to account for technological progress and incidents involving the malfunctioning of medical devices. However, the regulation has received backlash for potentially curbing opportunities for early device development.
“Doing smaller trials like feasibility with new devices is becoming more difficult. It is more attractive for smaller companies to do [feasibility studies] in the US than in Europe, which was different 8-10 years ago,” said Sauerland.
Moreover, the FDA has provisions for acquiring a breakthrough device designation, which can facilitate interactions with the regulators to discuss study designs, said Enrico Perfler, founder of medtech contract research organisation (CRO) 1MED.
Against such a backdrop, Perfler said the DACH region is “very attractive”. Switzerland may have an advantage due to its independent health authority Swissmedic, explained Ina Meyer, study and site operations country manager for Switzerland at Novartis.
Meyer said that the authority can be leveraged to speed up study start-up timelines. “Swissmedic is keen on FDA feedback and the same with the EMA [European Medicines Agency]. As own health authority, and not part of the EU, It’s an advantage to be able to submit at any time.”
Nonetheless, the panel highlighted that recruitment can be a challenge in the DACH region. There has been progress in electronic health records and digitalisation, but there is a need for better patient identification using real-world evidence during the recruitment process, said Meyer.
Sauerland added that successful patient recruitment is also about informed site selection and going beyond academic university hospitals: ”What we saw in the past is in small towns in North-East Germany…had very good recruitment and good compliance sites and patients. This is important for our device; we need compliant patients that use it right.”
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