Impact of the InVitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024

In Vitro Diagnostic (IVD) tests are critical to clinical trial operations, serving to help select patients in clinical trials, provide accurate efficacy results, monitor patient response, and more. In May of 2022, the In Vitro Diagnostics Regulation (IVDR) in the European Union and the European Economic Area (EU/EEA) went into effect, seeking to ensure higher patient safety for medical devices, requiring device manufacturers to conduct more stringent safety and performance studies for said devices.

As a result, current and pending drug clinical trials utilizing IVD tests now must also adhere to the IVDR. Compliance among clinical drug trials with the IVDR means IVDs used in clinical trials providing a diagnostic test result that will influence patient medical management must go through a Performance Study, which requires submission of a Performance Study Application (PSA). However, this process is currently complex and uncoordinated, resulting in delays in clinical trials and patients waiting longer to participate in clinical trials, or even not participating at all. 

This landmark report includes 90 biopharmaceutical participants from the United States and Europe and explores the impact of these delays on clinical trial CRO partnerships, with detailed findings on potential strategies and/or shifts to be implemented by biopharmaceutical companies to mitigate the current and expected delays caused by the IVDR. 

In the report, the analysts provide commentary and interpretation of the data, which reflects more than 30 years of experience consulting to many of the leading global biopharmaceutical companies, clinical development CROs and CRO industry analysts. The report looks at the preferences among biopharmaceutical respondents for CRO partnerships and clinical trial site locations and how might these preferences change for clinical trials ongoing in the EU/EEA that are/will be impacted by the IVDR.