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 at 5 PM (CEST) / 11 AM (EDT).
The in vitro diagnostic Regulation (IVDR) came into effect in May 2022 and aims to ensure patients’ safety, provide a more transparent framework for IVDs and deliver access to innovative medical technologies. However, the implementation of the regulation has been challenged by a lack of infrastructure, guidance and coordination, triggering a series of unintended and critical consequences for patients.
Following an EFPIA internal survey, the data show that more than 100 clinical trials are currently being delayed in Europe because of the IVDR, with an expected 238 to 420 trials to be delayed over the next 3 years. These delays mean that more than 40,000 patients in Europe are expected to have delayed access to clinical trials over the next 3 years, and around half of them being cancer patients.
EFPIA is working on complementary policy recommendations that would alleviate some of the barriers created by the implementation of the IVDR and discussing them with policy makers to improve access for European patients to those innovative clinical trials.
Agenda: (CEST time zone)
17:00 – 17:05 Introduction – Jaap Verweij (CDDF, NL)
17:05 – 17:25 Presentation – Audrey Wolf
17:25 – 18:00 Discussion – moderated by Jaap Verweij and Ruth Plummer