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PRIME-ROSE – A European precision cancer medicine trial network and implementation initiative funded by the EU Cancer Mission

The European Commission, on 24 April 2023, approved the project Precision Cancer Medicine Repurposing System Using Pragmatic Clinical Trials, PRIME-ROSE. The project will officially start on 1 July 2023 and is funded by the European Commission Horizon Europe Mission on Cancer (grant no. 101104269) with 5.969 mill EUR. PRIME-ROSE will run for five years (2023 – 2028). The consortium consists of altogether 24 partners, including nine beneficiaries and fifteen associated partners. In addition, PRIME-ROSE is part of the Cancer Mission cluster of projects on Diagnosis and Treatment.

The Centre for Innovation in Medicine (INOMED) is an Associated Partner of the Project.

“We have many medicines at our disposal, but unfortunately, we still know too little about the categories of patients who can truly benefit from them. Personalized medicine has the potential to breathe new life into existing drugs that are not being used to their full potential, for the benefit of both patients and healthcare systems. We are honored to be part of the PRIME-ROSE project because it gives us the opportunity to learn from the best about personalized medicine in oncological practice, while at the same time preparing for the implementation of these approaches in the Balkan states to reduce East-West inequalities through innovation.”

Dr. Marius Geantă, President of INOMED

Sustainable and affordable precision cancer medicine across Europe

The PRIME-ROSE vision is access to affordable Precision Cancer Medicine (PCM) that prolongs life at the best quality possible for all cancer patients. PCM is an approach that depends on access to adequate molecular diagnostics and drugs to have an impact and move towards implementation in the national healthcare systems. Today there is inequality in access to PCM between and within EU countries, and while the promise of PCM is clear, implementation remains a challenge. This, in particular, affects cancer patients with the poorest prognosis who have exhausted all lines of standard-of-care treatment, those with tumors carrying rare mutations, and patients with carcinoma of unknown primary.

The PRIME-ROSE project builds on a bottom-up, clinician-initiated family of PCM clinical trials which have been particularly successful in bringing up inclusion rates to offer additional lines of treatment and in providing patient benefit. These trials share the pragmatic clinical trial design of the original Dutch DRUP trial, with broad inclusion criteria and a limited set of endpoints. However, the trials are still anchored into a national context and are funded independently. The result is a distributed DRUP-like clinical trial network that addresses local priorities while collaborating internationally for scale and impact.

Work to be done in PRIME-ROSE moving PCM forward in Europe

The consortium will use these existing adaptive and pragmatic clinical trial platforms to answer key questions regarding clinical effectiveness, provide health-economic evaluations, and contribute to scientific progress across cancers. In particular, the cross-country collaboration provided by PRIME-ROSE will build capacity as well as enable cross-trial data aggregation and analysis, initiate shared cohorts across borders, and provide health-economic evaluations. To ensure successful implementation, the consortium will work together with regulators, policymakers, payers, healthcare providers, and patient advocacy groups to implement evidence-based PCM in routine practice and address inequalities in access.

Altogether, this Europe-wide precision cancer medicine deployment will address key scientific and methodological questions to accelerate broad and equitable access to new and effective cancer treatments. The ongoing effort is already leading to harmonization, standardization, and pragmatic consensus.

Pan-European precision cancer medicine community: PRIME-ROSE project is led by Professor Kjetil Taskén, Head of the Institute for Cancer Research at Oslo University Hospital Comprehensive Cancer Centre in Norway.

PRIME-ROSE Consortium Partners:

  1. Oslo University Hospital, Oslo, Norway
  2. Leiden University Medical Center, Leiden, The Netherlands
  3. Stockholm School of Economics, Stockholm, Sweden
  4. Capital Region, Copenhagen, Denmark
  5. Helsinki University Hospital, Helsinki, Finland
  6. Centre Leon Berard, Lyon, France
  7. IPOPORTO, Porto, Portugal
  8. Region Uppsala, Uppsala, Sweden
  9. The Swedish Institute for Health Economics, Lund, Sweden
  10. Karolinska Institutet, Stockholm, Sweden
  11. Region Skåne, Sweden
  12. Heidelberg University Hospital, Heidelberg, Germany
  13. Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland
  14. University Hospital of Split (KBC Split), Split, Croatia
  15. Tartu University Hospital, Tartu, Estonia
  16. National Institute of Oncology, Budapest, Hungary
  17. Vall D’Hebron Institute of Oncology, Barcelona, Spain
  18. Center for Personalized Cancer Treatment (CPCT, DRUP trial consortium), hosted by Radboud University Medical Center, Nijmegen, The Netherlands
  19. National Cancer Institute, Vilnius, Lithuania
  20. Cancer Research UK, London, UK
  21. University of Manchester, Manchester, UK
  22. Trinity College Dublin, Dublin, Ireland
  23. Masaryk Memorial Cancer Institute (MOU), Brno, Czech Republic
  24. Center for Innovation in Medicine (CIM), Bucharest, Romania
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