Support a pragmatic clinical trial programme by cancer charities

ExpectedOutcome:

An important aim of Missions is bringing together various disciplines, sectors and actors, such as philanthropy. Hundreds of cancer charities and foundations across Europe support patient-centred research, including clinical trials.

Pragmatic clinical trials focus on choosing between care options. Pragmatic trials evaluate effectiveness, the effect of treatment in routine (real-world) clinical practice. Some examples include treatment versus active surveillance in patient management, a combination of treatment interventions, determination of optimal dose and dose schedules, de-escalation of treatment intervention, comparative effectiveness of different treatment interventions.

The successful proposal under this topic should aim to deliver results that are directed and tailored towards and contribute to all of the following expected outcomes:

• Together, a network of registered cancer charities and foundations support multi-centre, transnational pragmatic clinical trials on cancers with a 5-year overall survival less than 50% from time of diagnosis or rare cancers using their own resources.
• Cancer patients and their caregivers have access to more effective and patient-centred, treatment and care solutions.
• Researchers, innovators, and professionals from different disciplines and sectors ensure accessibility and re-usability of relevant trial data, to support the UNCAN.eu^[1] research data platform, which is currently in preparation.
• National healthcare providers, policymakers and authorities in European regions, Member States and Associated Countries have the evidence to implement affordable and accessible treatment and care solutions in their healthcare systems.

Scope:

The EU contribution aims to facilitate the coordination and networking between charities themselves as well as with relevant stakeholders across Member States and Associated Countries. The EU contribution will not co-fund the trials.

Proposals should address all of the following:

• Together, registered cancer charities and foundations across Europe, organise, fund and implement at least two transnational calls for proposals, resulting in grants to academic investigator-led third parties to conduct randomised multi-centre pragmatic clinical trials. The trials should deliver, affordable, accessible and evidence-based treatment or care interventions for implementation by healthcare systems at the level of local communities, European regions, Member States and Associated Countries.
• Organise annual networking activities between charities, the successful academic investigators, citizen representatives and stakeholders across Member States and Associated Countries across Europe;
• With respect to the pragmatic trials.
• The chosen intervention(s) should be adapted to the particular needs of the target population and to the specificities of the provision of care at local, regional, or national level, duly reflecting the diversity across Member States and Associated Countries.
• The chosen intervention(s) should take into account socio-economic and biological stratification. All data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status.
• The successful grants to third parties will address interventions for patients with cancers with a 5-year overall survival of less than 50% from time of diagnosis^[2] or rare cancers^[3], at any stage of the disease, for any cancer subtype, in any age group or part of society.
• Timely contact with regulatory authorities should be foreseen to inform the trial design and feasibility.

This topic requires the effective contribution of SSH disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise in the successful proposal, to produce meaningful and significant effects enhancing the societal impact of the related research activities.

The successful proposal is expected to build on the support of the Knowledge Centre on Cancer (KCC)^[4] to foster EU alignment and coordination.

The Commission will facilitate coordination. Therefore, successful proposals will be asked to join the 'Diagnostics and Treatment' cluster for the Mission on Cancer established in 2022^[5] and should include a budget for networking, attendance at meetings, and potential joint activities without the prerequisite to give details of these at this stage. Examples: organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. The details of joint activities will be defined during the grant agreement preparation phase and during the life of the project.

[1]Under the Mission work programme a Europe-wide research and data platform, UNCAN.eu, will be established, utilising existing, relevant research infrastructures. Once operational, the platform should enable integration of innovative models and technologies with longitudinal patient data, data beyond research, or the health domain, samples and biomarkers for translation to patients.

[2]So called ‘refractory cancers’

[3]Defined as cancers with an incidence of less than 6 per 100,000 persons per year. See: https://www.rarecarenet.eu/rarecarenet/cancerlist.

[4]Hosted by the European Commission's Joint Research Centre (JRC). Especially through the ’European Guidelines and Quality Assurance Schemes for Breast, Colorectal and Cervical Cancer Screening and Diagnosis‘, and the ’European Cancer Information System (ECIS)’ and the ’European Cancer Inequalities Registry (ECIR), see https://knowledge4policy.ec.europa.eu/cancer_en

[5]In order to address the objectives of the Mission on Cancer, participants will collaborate in project clusters to leverage EU-funding, increase networking across sectors and disciplines, and establish a portfolio of Cancer Mission R&I and policy actions.