The Cancer Drug Development Forum (CDDF) held a live webinar on “Critical Impacts of the In Vitro Diagnostic Regulation (IVDR) Implementation on Patient Access to Clinical Trials“ on Thursday 07 September 2023. In this webinar, Audrey Wolf (EFPIA) presented the EFPIA’s survey results on the topic and current status followed by a Q&A session moderated by Ruth Plummer and Jaap Verweij (CDDF, NL). Here are the key takeaways from the webinar:
- A major challenge within Europe for clinical trial set up is that the PSA (Performance Study Application, to authorise the use of an IVD in a clinical trial) and the CTA (Clinical Trial Application , to authorise the launch of a clinical trial) are running in parallel with a lack of coordination causing very significant delays following the implementation of the in vitro diagnostics Regulation (IVDR).
- EFPIA survey of its members indicated that this lack of coordination, in addition to structural issues, are causing estimated delays of clinical trials launches of 6 to 12 months, making the EU less competitive for trial placement compared to rest of the world and reducing access to novel agents for our patients
- These challenges have been recognised at a European Commission and regulatory body level and a number of solutions are currently being evaluated.
- A step forward is the recent launch of the COMBINE project by the Commission to analyse and address these issues caused by the interface between the 3 legislations – IVDR/MDR/CTR, with the support of relevant multistakeholders from European and National levels.
To view the key takeaway video, click HERE
To read the presentation slides from speakers, click HERE