The approval of the European Union's In Vitro Diagnostics Medical Devices Regulation, or IVDR, back in 2022 was an important step in the framework of advancing research in Europe and warmly welcomed by ESMO and the oncology community. The IVDR aimed to improve patient safety, provide a more transparent framework for in-vitro diagnostics, and facilitate the delivery of innovative cancer treatments.
However, its implementation has introduced complexities that hinder clinical trial development.
- The IVDR sets stricter requirements for the diagnostic tests used in clinical trials
These tests are essential for determining patient eligibility, monitoring treatment response, and assessing safety and efficacy outcomes across the EU’s 27 Member States.
Such requirements include the authorisation of a performance study application prior to enrolling patients if a new diagnostic is being developed to identify patients for a clinical study of a novel cancer medicine; the authorisation of a clinical trial application for the medicinal product study and ethics committee approval.
- The IVDR requires a coordinated assessment of the performance study protocol
Sponsors have to submit the protocol into the European database on medical devices (EUDAMED), with a single Member State, then coordinating feedback for European clinical trials, reviewing, and approving progression of the performance study.
Unfortunately, as neither the coordinated process, infrastructure, nor the necessary guidance are available to enable this streamlined option, the study sponsors must independently apply to every Member State involved in the clinical trial.
- In some cases, and for the same clinical trial, Member States and Ethics Committees require sponsors to provide different kinds of information.
Some Member States have divergent assessment of the information provided by the sponsor or different timing requirements for application submission, or unclear processes about where and how to submit a performance study application.
All of this, and much more, is leading to massively increased costs and bureaucracy that are particularly prohibitive for academic institutions and smaller companies.
Hundreds of trials are being delayed in Europe due to these unintended consequences which combine to pose an existential threat to Europe’s role as a leader in global oncological research.
ESMO is advocating for these challenges to be tackled urgently, in a collaborative effort with patient representatives, policy makers, research institutes and industry -- amongst others, in order to secure Europe’s role in the vanguard of oncological research and facilitate the delivery of innovative treatments to the millions of patients with cancer.
In order to develop the necessary solutions, both mandatory and voluntary, and with hundreds of MEPs about to begin a new term in the European Parliament, we are looking for experiences from the laboratory about how the IVDR is affecting your research.
We would be pleased to receive your feedback which we can use to have a stronger voice in advocating for a better future of cancer research and for the benefit of our patients.
Please share your observations by emailing to publicpolicy@esmo.org