EFPIA：2024年评估欧洲的临床试验生态系统最终报告（英文版）

There has been a decline in the clinical trial starts for oncology, neurology, rare disease, immunisation and paediatric trial s. • Some reports suggest the In-vitro Diagnostic Regulation (IVDR), which introduced more stringent requirements for the designation of Notified Bodies and affected device risk classifications, pose operational challenges for multi-region trials in oncology (and other trials highly dependent on in-vitro testing). The implications of this regulation on clinical trial act