Pragmatic clinical trials to optimise immunotherapeutic interventions for patients with refractory cancers

Expected Outcome: Proposals under this topic should aim to deliver results that are directed and tailored towards and contribute to all of the following expected outcomes: Patients with refractory cancers and their caregivers/families will have access to optimised, tailored and affordable immunotherapeutic interventions that increase their quality of life, across European regions, EU Member States and Associated Countries; Healthcare professionals and academia will have access to clinical evidence, on effectiveness of immunotherapeutic interventions, to deploy evidence-based treatment interventions with improved patient selection that improve outcomes in real life, i.e. in routine healthcare, for patients with refractory cancers who often present with co-morbidities; National healthcare providers, policymakers and authorities in European regions, EU Member States and Associated Countries will have the evidence to implement and reimburse optimised and affordable immunotherapeutic interventions in their healthcare systems, including in everyday medical practice. Scope: While cancer research and innovation have generated novel treatment options, patients with refractory cancers across Europe need access to more effective, affordable and tailored cancer immunotherapeutic interventions which keep up with increasing demands in a complex and fragmented oncology healthcare landscape with spiralling healthcare costs. 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 [1] . Proposals should address all the following: Conduct randomised or cluster-randomised academic investigator-initiated [2] 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, pati…