Funded by the European Union
Combining expertise across borders to promote Precision Cancer Medicine in Europe. The PCM4EU is a project under Europe’s Beating Cancer Plan by EU4Health, with partners from 15 countries across Europe.
Personalised Cancer Medicine for Europe, PCM4EU, is a project under the Europe’s Beating Cancer Plan by EU4Health. PCM4EU is about facilitating implementation of molecular cancer diagnostics for precision oncology, and the consortium consists of partners from altogether 15 countries across Europe.
Millions of people in the EU are negatively affected by cancer, and cancer is one of the leading causes of death and morbidity in Europe. Personalised Cancer Medicine (PCM) is an emerging approach where patients are given more precise and targeted diagnostics and treatment. However, the approach depends on access to adequate molecular diagnostics and drugs to have impact and move towards implementation. Today there is still inequality in access to PCM between and within EU countries, and while the promise of PCM is clear, implementation remains a challenge.
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The PCM4EU project is set up to facilitate the use of precision cancer medicine diagnostics and pragmatic trials across Europe, and it builds on the family of DRUP-like clinical trials. The consortium aims at using already existing entities as well as use proven successes of best practices to widen the access to molecular diagnostics and precision cancer medicine within regions and countries in the EU.
In the European Union, healthcare systems fall under national responsibility and differ greatly in structure, financing and capacity. At the same time, European countries are predominantly small, thus, limiting the evidence that can be generated nationally in a reasonable period of time. The family of DRUP-like clinical trials addresses this challenge. As a bottom–up, clinician-initiated network, DRUP-like clinical trials (DLCTs) share the pragmatic core clinical trial design of the original DRUP trial, with broad inclusion criteria and a limited set of endpoints. However, the trials are still anchored into national context and financed independently. The result is a distributed DRUP-like clinical trial network that addresses local priorities while collaborating internationally for scale and impact.
PCM4EU will:
Evaluate current standards and provide best practice guidelines
Provide recommendations on state-of the-art genomic diagnostics, implementation and interpretation
Build shared cross-DLCT capacity in molecular diagnostics
Facilitate mechanisms for interpretation of molecular and clinical data through harmonization and collaboration, thereby anticipating the benefits of the upcoming European Health Data Space
Facilitate cross-border access to genomic testing and precision cancer medicine
Facilitate implementation of results into the healthcare system in a cost-effective manner
Provide education for all stakeholders, including physicians, pathologists, patients and decision makers
Personalised Medicine offers the promise of improved patient outcomes while minimising undesired effects and costs. This is achieved by optimisation at the level of the individual rather than the group. Although conceptually intuitive, personalised medicine constitutes a paradigm shift in medicine and the traditional approach of evidence-generation in large, product-centred randomised clinical trials in molecularly uncharacterised patient populations. This not only presents a significant challenge for our current system of evidence generation for clinical, regulatory and health-economic evaluations but also requires novel concepts and capabilities, as well as an unprecedented degree of collaboration.
PCM4EU and the DRUP-like clinical trial community challenges the traditional approach of evidence-generation by introducing a critical step of stratification into molecularly defined cohorts with systematic evidence-generation and a pre-planned transition into national healthcare coverage via an outcome-based risk sharing agreement. Through a successful implementation of PCM4EU and connected initiatives, we envision broad European impact in short, medium and long term:
Oncologists will be able to offer personalized treatment options to cancer patients with no alternatives, with immediate potential benefit to European Citizens.
PCM4EU provides oncologists not only with additional options for a patient population with high unmet needs (and with that member states with services for their citizens), but also access to a European-wide multi-stakeholder network of PCM expertise that will be reinforced by the training opportunities within PCM4EU.
Furthermore, PCM4EU provides test cases for interaction in general, but also the establishment of risk-sharing agreements involving academia as well as national Health Technology Assessment bodies and payers.
The European oncological community will:
Be increasingly competitive in the PCM space thanks to increased connections, shared knowledge and established collaborative partnerships
Drive the nation-wide adaptation of molecular diagnostics for the benefit of patients
Health Technology Assessment bodies and payers will gain exposure and experience to the shifting landscape towards algorithm-based medicine and develop novel methodology for the evaluation of PCM approaches.
In addition, the harmonisation of standards, recommendations and guidelines will greatly facilitate European collaboration in the field of precision medicine. Effective networks and expertise in PCM implementation in a stakeholder system as diverse as the European will ensure that Europe’s upcoming Partnership for Personalised Medicine rapidly results in benefit for patients and societies.
Europe accounts for less than 10% of the world population, but stands for close to a quarter of all cancer cases and a fifth of cancer deaths (Globocan 2020).
By creating networks, structures and expertise, PCM4EU will contribute to enable the critical first step towards a Europe-wide approach that uses precision cancer medicine to optimise outcomes in a sustainable way for societies.
The ultimate goal is for Europe introduce a new deal that will ensure equal access to innovation and effective therapies for all European citizens.
