#EUCANCERPLAN

Personalised Cancer Medicine for all EU Citizens

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.

PCM4EU

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.

Background

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.

Project Mission

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

Impact & Ambitions

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:

Training Resources

PCM4EU is preparing a series of training sessions, both physical meetings and digital events, courses and podcasts. Furthermore, online tools to guide both patients and physicians on how to access precision cancer medicine will be made available regularly.

Collected posts about PCM4EU