Pragmatic clinical trials focus on choosing between care options. Pragmatic trials evaluate effectiveness of interventions in settings that more closely resemble routine, real-world settings, aiming to produce evidence directly applicable to clinical practice.

Proposals should address all the following:

• Conduct randomised or cluster-randomised academic investigator-initiated pragmatic clinical trials that benefit patients with refractory cancers – at any stage of the disease, for any cancer subtype, in any age group or part of society – to deliver effective, affordable and tailored immunotherapeutic interventions for implementation by healthcare systems at the level of local communities, European regions, EU Member States and Associated Countries.
• All data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status or ethnicity. Translational research is limited to supporting biomarker-informed patient stratification and the conduct and analyses of the proposed clinical trial(s).
• The primary and secondary endpoints of the pragmatic clinical trials should target overall survival, patient-reported outcomes and quality of life issues considered important by and for cancer patients and their caregivers/families. Such endpoints should be defined together with patients and their caregivers/families through research that stimulates social innovation and supports end-user engagement using participative research models.
• The chosen treatment 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 EU Member States and Associated Countries. Furthermore, affordability and accessibility should be taken into account.
• Applicants should include an appropriate mix of stakeholders from various disciplines, sectors and regional as well as national health authorities, and provide details of the clinical study(ies) in the dedicated annex using the template provided in the submission system.

The successful proposals are expected to build on resources made available by the Knowledge Centre on Cancer (KCC) to foster EU alignment and coordination.

Successful proposals will be asked to join the ‘Diagnosis and Treatment’ cluster for the EU Cancer Mission and should include a budget for networking, attendance at meetings, and joint activities. The Commission will facilitate coordination of these activities.