Deadline: 7-Sep-22
The European Commission (EC) is offering grants for Pragmatic Clinical Trials to Optimise Treatments for Patients with Refractory Cancers.
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, combination of treatment interventions, determination of optimal dose and dose schedule, de-escalation of treatment intervention, comparative effectiveness of different treatment interventions.
Details
Proposals should address all of the following:
- Design and conduct randomised or cluster-randomised academic investigator-initiated pragmatic clinical trials to deliver effective and evidence-based treatment interventions for implementation by healthcare systems at the level of local communities, EU Regions, Member States and Associated Countries, taking into account socio-economic and biological stratification, such as biology of the disease, gender, cancer stage, and age.
- 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 Member States and Associated Countries. Furthermore, affordability and accessibility should be taken into account.
- The successful proposals will address treatment interventions for patients with refractory cancers (cancers with a 5-year overall survival of less than 50% from time of diagnosis) at any stage of the disease, for any cancer subtype, in any age group or part of society.
- The successful proposals should clearly justify and describe the evidence supporting the chosen treatment intervention.
- The primary and secondary endpoints of the pragmatic clinical trial should target overall survival, patient-preferred clinical benefit, patient-reported outcomes and quality of life issues considered important by and for cancer patients and their caregivers. Such endpoints should be defined together with patients and their caregivers through research models that use open knowledge, (social) innovation systems and support end-user engagement (e.g. living labs).
- Implementers of pragmatic clinical trials and trial results should include physicians, academia, patients and their caregivers, patient representatives, payers, charities and foundations, research organisations, civil society, regional and national research and innovation organisations, and health authorities.
- Successful pragmatic clinical trials, including their analyses, should be completed within 5 years after the start of the project. Translational research is not within the scope of this topic.
- In all instances, sex- and gender-related issues must be taken into account. All data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status.
Funding Information
The check will normally be done for the coordinator if the requested grant amount is equal to or greater than EUR 500 000, except for:
- public bodies (entities established as a public body under national law, including local, regional or national authorities) or international organisations; and
- cases where the individual requested grant amount is not more than EUR 60 000 (lowvalue grant).
Expected Outcomes
Proposals under this topic should aim for delivering results that direct, tailor towards and contribute to all of the following expected outcomes:
- Cancer patients and their caregivers will have access to optimised and affordable treatment interventions that increase their quality of life, across EU regions, Member States and Associated Countries;
- Healthcare professionals and academia will generate clinical evidence, by evaluating effectiveness in randomised or cluster-randomised academic investigator-initiated pragmatic clinical trials, how to best perform and deploy evidence-based treatment interventions that improve outcomes in real life for routine healthcare, including quality of life, for cancer patients who often present with co-morbidities;
- National healthcare providers, policymakers and authorities in EU Regions, Member States and Associated Countries will have the evidence to implement optimised and affordable treatments in their healthcare systems, including in everyday medical practice.
Eligibility Criteria
To be eligible for funding, applicants must be established in one of the eligible countries, i.e.:
- the Member States of the European Union, including their outermost regions;
- the Overseas Countries and Territories (OCTs) linked to the Member States;
- eligible non-EU countries:
- countries associated to Horizon Europe
- low- and middle-income countries.
For more information, visit European Commission.
For more information, visit https://bit.ly/3LLqrnP