In Horizon Europe program, Cluster Health, are open four two-stage calls under destination 3 Tackling diseases and reducing disease burden with deadline for the first stage on the 19^th September 2023:

- HORIZON-HLTH-2024-DISEASE-03-08-two-stage: Comparative effectiveness research for healthcare interventions in areas of high public health need.

Scope:

• Compare the use of currently existing (pharmacological, non-pharmacological and technological) healthcare interventions in specific population groups (or selected subgroups).
• Ensure acceptability and sustainability of the healthcare intervention through early involvement of 'end users' (e.g. patients, care providers) in the design of the study (integrating patient valued outcomes) and, where possible, in the research process including implementation.
• Consider involving HTA bodies in order to create synergies and accelerate the practical implementation of the results. Where relevant, existing work of EU-funded projects such as EUnetHTA should be also taken into account.
• Consider issues of particular relevance for the target populations, for example, multimorbidity, complex chronic conditions, polypharmacy, substance misuse, vaccine efficacy, compliance, age, gender specificities and diseases with high societal burden (including but not limited to e.g. musculoskeletal diseases and mental health disorders). Special consideration should be given to fulfilling all ethical requirements.
• Among others. Please consult the call text.

Budget per proposal: between 6 and 7 million euros, expected 6 to 8 projects finance. 

Research and Innovation Actions benefits from a grant that covers 100% of the project costs.

- HORIZON-HLTH-2024-DISEASE-03-11-two-stage: Pandemic preparedness and response: Adaptive platform trials for pandemic preparedness.

This topic aims to provide funding to adaptive clinical platform trials that may be implemented routinely outside of an epidemic or pandemic context, but that are designed to be ready for the timely assessment of novel diagnostics, therapeutics or vaccines in the face of an epidemic or pandemic.

Scope:

• Development of robust clinical evidence that contributes to the knowledge base for the diagnosis, treatment and prevention of infectious diseases. Sex, gender, age, ethnicity and socio-economic factors should be taken into account.
• Known hurdles related to ethical, administrative, regulatory, legal and logistical aspects should be anticipated and addressed to the extent possible, in order to avoid such barriers when the trial needs to pivot in response to an epidemic or pandemic.
• Engagement with clinical researchers and biostatisticians, to increase capacity for the design and implementation of adaptive platform trials across Europe.

Budget per proposal: between 8 and 10 million euros, expected 3 to 4 projects finance. 

Research and Innovation Actions benefits from a grant that covers 100% of the project costs.

- HORIZON-HLTH-2024-DISEASE-03-13-two-stage: Validation of fluid-derived biomarkers for the prediction and prevention of brain disorders.

The brain disorders within the scope of this topic fall under two categories, namely those listed under chapters six and eight of the International Classification of Diseases169. Proposals in the area of mental disorders are encouraged.

Scope:

• Proposals should aim to validate biomarkers that can reliably confirm early stages of the human brain disorder and guide treatment/ intervention selection170 .
• Proposals should aim to provide evidence supporting the regulatory acceptance of the biomarkers171 .
• Exploitation of existing data, biobanks, registries and cohorts is expected, together with the generation of new key data.
• Inclusion of patients or patient organisations in the research is strongly encouraged, as to ensure that their views are considered.
• Sex and gender aspects, age, socioeconomic, lifestyle and behavioural factors should be taken into consideration in the study.
• To enable sharing of samples, quality data and advanced analytical and digital tools, consideration should be made for using infrastructures already developed at the European172 or national level.
• To enable the management of brain disorders, consideration should be made in demonstrating the gained cost efficiency.
• SME participation is encouraged

Budget per proposal: between 6 and 8 million euros, expected 3 to 4 projects finance. 

Research and Innovation Actions benefits from a grant that covers 100% of the project costs.

- HORIZON-HLTH-2024-DISEASE-03-14-two-stage: Tackling high-burden for patients, under-researched medical conditions.

A number of medical conditions fail to be recognised and/or be correctly diagnosed in a significant proportion of patients. As a consequence they are inadequately treated and often can become a chronic and high burden for the patient. These medical conditions may be insufficiently researched even though they manifest with high prevalence . This topic excludes rare diseases.

Scope:

• Proposals should address the gaps in robust, scientific evidence for improved policies and practices to tackle such medical condition(s), and aim at identifying the pathophysiological mechanism(s) (e.g. genetic, cellular and molecular) and potential risk factors (e.g. psychological and environmental) of the medical condition(s) through basic, pre-clinical and/or clinical research.
• Proposals should demonstrate that the medical condition(s) under study is/are insufficiently understood, inaccurately diagnosed or inadequately treated in a significant proportion of patients, and as such represent a high burden for patients and society.
• Sex and gender aspects, age, ethnicity, socio-economic, lifestyle and behavioural factors should be taken into consideration. In addition, the emotional and societal long-term effects of these chronic disorders for the affected individuals should be addressed.
• Where applicable, the development of biomarkers and other technologies for diagnosis, monitoring in patients, and stratification of patient groups should be considered.
• Among others. Please consult the Call text.

Budget per proposal: between 6 and 7 million euros, expected 3 to 5 projects finance. 

Research and Innovation Actions benefits from a grant that covers 100% of the project costs.

Three legal entities established in 3 EU Member States or countries associated to Horizon Europe. 

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