Clinical Trials in the DACH Region: Challenges and Opportunities in the Digital Age

The feasibility of clinical trials in the DACH region and worldwide was the focus of the Outsourcing in Clinical Trials (OCT) DACH 2024 conference, where concrete challenges in light of tightened EU regulations, increasing focus on digitalization and AI, as well as complex ethical issues were discussed. In Zurich, over the course of two days, pharmaceutical companies, biotech firms, contract research organizations, and other key players came together with the goal of debating the latest developments in technology, regulatory frameworks, and ethical standards in Germany, Switzerland, Austria, and worldwide. A central topic on the agenda was the EU regulations for clinical trials. Andrea Sauerland from Endatronix expressed concerns that the European Medical Device Regulation (MDR) could inhibit innovation, particularly for smaller companies. In contrast, according to Ina Meyer from Novartis, Switzerland, with its independent authority Swissmedic, might offer some advantages. The focus was also on the collaboration between sponsors, CROs, and clinical sites to overcome challenges like patient recruitment. The use of real-world data for better patient identification is crucial, Meyer noted. Global insights emphasized the importance of inclusivity and diversity in clinical trials. Vasee Moorthy from the WHO presented new guidelines aimed at reducing "research waste" and promoting more equitable research. The use of AI in drug development and research was portrayed as a transformative trend. Beyza Karakoy from GlobalData urged the industry to decisively embrace AI. However, ethical and regulatory challenges, particularly regarding data protection and patient safety, remain.