#MISSIONCANCER #HORIZONEUPRIME-ROSE - Combining Expertise Across Borders to Promote Precision Cancer Medicine in Europe
PRIME-ROSE (Precision Cancer Medicine Repurposing System Using Pragmatic Clinical Trials) is a Horizon Europe Mission on Cancer project with 24 partners from altogether 18 European countries. Moreover, PRIME-ROSE is part of the Cancer Mission cluster of projects on Diagnosis and Treatment.
PRIME-ROSE
We are very excited to be an active part of PRIME-ROSE and thus contributing to steps towards the vision to secure access to affordable Precision Cancer Medicine that prolongs life at the best quality possible for all cancer patients.
A European precision cancer medicine trial network and implementation initiative funded by the EU Cancer Mission. 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.
Background
PRIME-ROSE (Precision Cancer Medicine Repurposing System Using Pragmatic Clinical Trials) is funded by the EU Cancer Mission and will run over five years (2023 – 2028). The consortium consists of altogether 24 partners.
Millions of people in the EU are affected by cancer, and cancer is one of the leading causes of death and morbidity in Europe. PRIME-ROSE shares the ambition of the EU Cancer Mission to save and improve 3 million lives by 2030, and fully endorses the need for sustainable and affordable access to new and innovative drugs for cancer patients in Europe.
Precision cancer medicine is an approach that depends on access to adequate molecular diagnostics and drugs to have impact and move towards implementation in the national healthcare systems.
Today there is inequality in access to precision cancer medicine (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, rare tumors, those with tumours carrying rare mutations and patients with carcinoma of unknown primary.
PRIME-ROSE objectives:
Increase access to optimised and affordable treatment interventions that prolong life and increase cancer patient’s quality of life
Generate clinical evidence and evaluate effectiveness in PCM-relevant and synthetically randomised evidence-based treatment interventions that improve outcomes in real life for routine cancer care
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
Project Mission
The PRIME-ROSE vision is access to affordable precision cancer medicine that prolongs life at the best quality possible for all cancer patients.
The PRIME-ROSE consortium composition reflects the unique approach taken by the community that has assembled around the shared interest of providing cancer patients who have exhausted other treatment options with access to precision medicine diagnostics and treatments.
PRIME-ROSE builds on a bottom-up, clinician-initiated family of precision cancer medicine 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. PRIME-ROSE is building on and collaborating closely with the related EU project PCM4EU.
PRIME-ROSE is treatment-oriented whereas PCM4EU focuses on deployment of novel PCM diagnostic tools. Altogether, this EU-wide precision cancer medicine deployment will address key scientific and methodological questions, leading to accelerated and improved access to new and effective cancer treatments. The ongoing effort is already leading to harmonization, standardization and pragmatic consensus.
PRIME-ROSE will:
Enable cross-border data sharing
Build synthetic randomised trials
Design and conduct pragmatic clinical trials
Provide the necessary data for implementation
Involve patients in a consistent and meaningful manner
Focus on multi-stakeholder collaboration
Share knowledge and provide education and training
Work package 6- Social Innovation for Access to PCM is lead by our college Bettina Ryll:
Precision cancer medicine represents a paradigm shift for the healthcare sector, and implementation requires contributions and consideration from several fields of expertise, including health economics, efficacy analyses, and organizational sciences as well as from legal experts on EU and national legislation. The current consortium builds and cross-links existing national networks for the implementation of precision medicine.
PRIME-ROSE and the closely related project PCM4EU (Personalised Cancer Medicine for all EU Citizens) cross-link PCM initiatives of a growing number of countries, allowing for complex multi-stakeholder interactions and cross- disciplinary work reaching beyond the classical medical setting. The access to necessary competence at national and international levels and established trusted relationships helps to pragmatically address and overcome potential hurdles. Project partners with complementary expertise, notably on the implementation process, on communication and on broad stakeholder engagement, will ensure that the project realises its desired social impact.
This work package will underpin the work of the DRUP community with the necessary foundation based on theories of system change in complex systems and innovation in healthcare, ensure synergies with other cancer-related initiatives and identify critical success factors for implementation. PRIME-ROSE aims to strengthen interactions especially with three stakeholder communities: regulatory authorities, the cancer patient community and payers.
WP6 will interact directly with WP3 (expansion cohorts) and WP4 (early access & drug repurposing) to give input on patient-relevant endpoints in this specific clinical setting. Collaboration with the European Medicines Agency (EMA) and the cancer patient advocacy community on patient utilities of trial outcomes will further provide a better understanding of how certain outcomes impact patients. This ensures that long-term, clinical trials capture outcomes that not only prolong but also truly improve the lives of patients.
The project will build on already existing patient involvement to ensure patients are consistently and meaningfully involved and contribute to the development of novel pragmatic and personalised outcome-based risk sharing agreements. Furthermore, the patient involvement will help reduce inequality in cancer by enabling access to treatment options for all patients in Europe. Read more >>>
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