Addressing the Complexities of Using in Vitro Diagnostics (IVDs) in Global Clinical Trials

Description: The regulatory landscape for in vitro diagnostic devices (IVDs) has undergone significant transformation, particularly with the implementation of IVDR 2017/746 in the European Union. This regulation imposes stricter requirements on IVDs used in clinical trials, including the need for a clearly defined intended purpose, robust clinical evidence, compliance with the General Safety and Performance Requirements (GSPR) and the need for authorization/notification of certain studies. These changes have presented new challenges for trial sponsors, laboratories, and diagnostic developers working on a global scale.

One of the primary hurdles lies in the disconnect between global regulatory frameworks. In the United States, Laboratory Developed Tests (LDTs) remain a common solution under CAP/CLIA standards, but these often lack the validation and evidence needed to meet the IVDR’s requirements. This creates a particular challenge for global trials, where devices must comply with varying standards, and gaps in validation or documentation can lead to delays and added complexity.

For IVDs used off-label or as LDTs, the lack of rigorous analytical and clinical validation data, coupled with poorly defined intended purposes, highlights the need for a more structured approach to compliance. The IVDR's demands extend beyond CAP/CLIA requirements, emphasizing comprehensive evidence generation, risk management, and alignment with IVDR Annex I.

Furthermore, studies involving central testing laboratories located outside the EU face logistical and regulatory hurdles. Ensuring compliance across jurisdictions while maintaining study timelines and managing costs requires early collaboration between sponsors and testing laboratories to address these challenges proactively.

This presentation will examine the evolving requirements for IVDs in global clinical trials and offer practical solutions to help sponsors navigate these complexities. By exploring real-world examples and providing actionable insights, this session will empower attendees to tackle the challenges of integrating IVDs into clinical trials, ensuring compliance, and driving successful trial outcomes in a rapidly changing regulatory environment.