Calls

Description :

FIGHT KIDS CANCER is thrilled to announce that its next call opening on September 1st, 2023 will be exclusively dedicated to research on paediatric brain tumours.

In order to substantially support this disease area, which is in dire need for new treatments, FIGHT KIDS CANCER decided to give more flexibility to the applying teams by increasing the possible amount available and duration per grant application:

• For clinical trials:
  o    Up to 5 years
  o    Up to 5 million euros
• For translation research projects:
  o    Up to 4 years
  o    Up to 2 million euros

As flexibility is the key motivation for the modification of the grants' duration and amount, the FKC Funders wants to stress the fact that applicants should apply for what they need and not refrain from applying for smaller amounts or shorter projects such as primer/ preliminary studies, projects or programmes grants.

Each project will be evaluated on its merit alone. Shorter, high-risk high gain projects are as welcome as are biology companion projects. Translational projects applying for longer duration or higher amounts will be expected to facilitate collaboration across institutions and borders within Europe to meet the FKC selection criteria.

FIGHT KIDS CANCER aims to catalyse and support pan-European leading-edge research initiatives in paediatric cancer to develop innovative approaches to improve the outcome for all children and adolescents with cancer. This call will cover the following non-exclusive objectives:

• Realise the real impact on young patients,
• Improve survival rates and reduce toxicity to restore young patients to full health after treatment,
• Advance fundamental knowledge of paediatric malignancies,
• Support improved interdisciplinary research, methods and collaborations for tackling the issues of today,
• Strengthen collaboration and the development of scientific capacity across Europe.

FIGHT KIDS CANCER aims towards overcoming the structural lack of research dedicated to paediatric cancers by ensuring a recurring endowment that will be granted to the best European research projects every year. An additional ambition is to foster closer working ties between clinical and laboratory researchers.

How to submit an expression of interest?

We invite you to consult the guidelines of the call here, also available on the submission platform.

The following template is to be used to submit your Expression of Interest.

The deadline to submit your expression of interest to the FKC paediatric brain tumours call is the 17^th of October 2023 at 16:00 CEST.

The submission platform guidelines can be downloaded here

Description :

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to most of the following expected outcomes:

• The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to underpin the development of the diagnostics, and as such can also facilitate the development of effective therapeutics and/or preventive strategies.
• The scientific and clinical communities advance the field through a better understanding of mechanisms underlying brain disorders at the molecular, cellular and systemic level.
• The scientific and clinical community make wide use of newly established and where relevant open access databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR principles, thereby encouraging further use of the data.
• Policymakers, funders, scientific and clinical communities, patient organisations, regulators and other relevant bodies are informed of the research advances made, while health professionals envisage use of the biomarker tests for early detection of the disorder and for guiding patients in the selection of personalised treatments/interventions.
• Patients and caregivers are sufficiently engaged with the research, which also caters for their needs.

Scope:

Treatments for some high-burden brain disorders are potentially on the horizon. Consequently, many patients and citizens will want to know if they are eligible for these treatments. For some disorders, a definitive diagnosis is difficult, expensive and time-consuming. Simple blood or other fluid-derived (e.g. saliva, urine, sweat) tests for markers that may indicate early signs of the disorder, and which can be deployed for widespread clinical use are needed.

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 Diseases. Proposals in the area of mental disorders are encouraged.

Proposals should address all of the following aspects:

• Proposals should aim to validate biomarkers that can reliably confirm early stages of the human brain disorder and guide treatment/ intervention selection.
• Proposals should aim to provide evidence supporting the regulatory acceptance of the biomarkers.
• 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, socio-economic, 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 European^[6] or national level.
• To enable the management of brain disorders, consideration should be made in demonstrating the gained cost efficiency.
• SME participation is encouraged.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

Description :

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• A diverse and comprehensive EU landscape of multi-country adaptive platform trials (i.e. able to study multiple interventions in a disease or condition in a perpetual manner, thus allowing modification to the trial after its initiation without undermining its validity and integrity) that assess vaccines and therapeutics for infectious diseases, and have the capacity to pivot rapidly in the case of epidemic or pandemic health threats.
• Innovative and improved design of clinical studies, suited for pandemic preparedness, is available for the clinical research community, taking into account the high safety standards in the European regulatory environment.
• Trial sites across multiple countries have the capacity to deliver robust clinical evidence in a diverse European population, using harmonised research methods, data collection and analysis.

Scope:

As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Health threats are expected to arise due to among others, climate change, and thus a need for proactive approaches to ensure timely availability of medical countermeasures during disease outbreaks is anticipated. The conduct of perpetual adaptive platform trials, with the in-built agility to pivot when an epidemic strikes, is key to be prepared for infectious disease epidemics or pandemics.

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.

Proposals should develop the wide range of elements needed to sustain multi-country adaptive platform trials, including the trial implementation capacity, laboratory analysis capacity, and a harmonised approach to the collection, storage, sharing and analysis of FAIR data.

Proposals should ensure timely engagement with regulatory authorities and bodies. Proposals should consider the European regulatory environment and take full use of the European capacity to deliver quality trials, including the possibility for registration of new medical products. Proposals should strengthen the leading role of the EU in clinical research preparedness for future epidemics and pandemics.

The proposals should address the following areas:

• 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.

Collaboration and coordination with existing adaptive platform trials in the EU is expected, where relevant, as well as with the coordination mechanisms established under topic HORIZON-HLTH-2023-DISEASE- 3.05 and with the European Medicines Agency (EMA). Collaboration and coordination with other organisations and other regional and global initiatives, such as Global Health EDCTP3 Joint Undertaking, the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), the European Pandemic Preparedness Partnership and the European Health Preparedness and Emergency Response Authority (HERA) should be envisaged. International cooperation is encouraged.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

Description :

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to most of the following expected outcomes:

• Health policymakers are aware of the healthcare interventions (pharmacological, non-pharmacological or technological interventions; including preventive and rehabilitative actions) that are identified as working best for the specific population groups from the point of view of safety, efficacy, patient outcomes, adherence, quality of life, accessibility, and (cost-) effectiveness.
• Health professionals have access to and use the improved clinical guidelines on the optimal treatment of patients and prevention of diseases e.g. through vaccines. Considerations made in the guidelines include the harmonisation and standardisation of care for high burden diseases or conditions throughout Europe, as well as possible individualised needs of patients.
• The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to develop interventions that are sustainable.
• Citizens, patients, prescribers, and payers receive more accurate information on available healthcare interventions via ad hoc communication platforms.
• The scientific and clinical communities make wide use of the newly established open access databases and/or integrate them with existing open access infrastructures for storage and sharing of collected data according to FAIR^[1] principles.

Scope:

Effective, affordable and accessible healthcare for diverse population groups is challenging and complex. For example, specific needs underlie the delivery of effective preventive actions and therapeutic treatments to a rapidly growing elderly population, often presenting comorbidities and associated polypharmacy. The paediatric population, including children born preterm, has also its specific needs in specially adjusted therapeutics and early interventions to address emerging health and developmental problems. Similar to the elderly population, the paediatric population is often excluded from many clinical trials that generate the evidence base for healthcare interventions. Women, including pregnant women, are also often under-represented in clinical studies and access to quality healthcare is frequently inadequate. Other population groups with limited access to quality healthcare and/or under-representation in clinical studies include low-income groups, and refugees. Intersectionality within these groups also needs consideration.

Proposals should address most of the following:

• Compare the use of currently existing (pharmacological, non-pharmacological and technological) healthcare interventions in specific population groups (or selected subgroups). While there is no restriction on diseases or conditions, preference will be given to proposals focusing on interventions with high public health relevance.

• 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. Additionally, proposals should take into account the diversity of health systems in different regions of Europe to allow large-scale uptake.

• 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.

• For the chosen population, assess clinical and safety parameters, as well as health and socio-economic outcomes (e.g. quality of life, patient mortality, (co)morbidity, costs, and performance of the health system). Agreed core outcome sets (COS) should be used as endpoints in conditions where they already exist, in other cases, efforts should be made to agree on such COS. Consider using new instruments and methods for determining the burden of disease and for evaluating the effects of the interventions. Low-cost innovations should also be considered.

• Inclusion of patient organisations and associations of caregivers and other healthcare professionals is recommended.

• Clinical trials, including pragmatic clinical trials, observational studies, use of existing health data in different study designs, creation of large-scale databases and performing meta-analyses may be considered for this topic. Use of existing data should always be considered to add value, increase quality and increase implementation speed of the study. Regarding databases, sustainability after the proposed action's end also needs to be considered.

• The proposed research needs to take into account sex and gender aspects.

The Commission will ensure an overall coordination mechanism between the projects funded under this topic to catalyse the exchange of knowledge, as well as the development and adoption of best practices. Proposals are expected to budget for the attendance to regular meetings. Projects resulting from this call will be invited to share and discuss their case studies amongst themselves and with relevant stakeholders at the EU level, and necessary resources should be allocated to this task.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

Description :

IHI call 5 is a single-stage call with topics on the 3Rs, theranostics, stroke management and synthetic data.

Topics

• Topic 1: Accelerating the implementation of New Approach Methodologies and other innovative non-animal approaches for the development, testing and production of health technologies
• Topic 2: Development and proof of principle of new clinical applications of theranostics solutions
• Topic 3: Improved prediction, detection, and treatment approaches for comprehensive stroke management
• Topic 4: Maximising the potential of synthetic data generation in healthcare applications

For full details of the topics, including the budget breakdown, click on the links above (which take you directly to the relevant page of the Funding and Tenders Portal) or read the call text.

Indicative budget

• The maximum financial contribution from IHI JU for these topics is: EUR 115 million
• Industry / contributing partner contributions: Applicant consortia should ensure that out of the total project budget, at least 45 % needs to be covered by contributions provided by project participants

How to apply

All documents relating to the call can be found via the Funding and Tenders Portal and the IHI call documents page. We advise you to read these documents, in particularly the guide for applicants, carefully.

Proposals must be submitted via the electronic submission system of the Funding and Tenders Portal. To start submitting your proposal, simply click on the relevant topic above - this will take you directly to that topic's page on the portal. Once there, scroll down and click on 'Start submission'.

To submit a proposal via the electronic submission system, you will need to have an EU Login account and ensure that your organisation is registered as a beneficiary.

Description :

IHI call 4 is a two-stage call with topics on the 3Rs, patient-centric blood sample collection, clinical trials, and the environmental impacts of healthcare.

Topics

• Topic 1: Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical safety assessment
• Topic 2: Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare
• Topic 3: Inclusive clinical studies for equitable access to clinical research in Europe
• Topic 4: Establishing novel approaches to improve clinical trials for rare and ultra-rare diseases
• Topic 5: Safe & sustainable by design (SSbD) packaging and single use device solutions for healthcare products
• Topic 6: Sustainable circular development and manufacturing of healthcare products and their quantitative environmental impact assessment

For full details of the topics, including the budget breakdown, click on the links above (which take you directly to the relevant page of the Funding and Tenders Portal) or read the call text.

Indicative budget

• The maximum financial contribution from IHI JU for these topics is: EUR 83 350 000 million
• Industry / contributing partner contributions: EUR 85 076 000 million

How to apply

All documents relating to the call can be found via the Funding and Tenders Portal and the IHI call documents page. We advise you to read these documents, in particularly the guide for applicants, carefully.

Proposals must be submitted via the electronic submission system of the Funding and Tenders Portal. To start submitting your proposal, simply click on the relevant topic above - this will take you directly to that topic's page on the portal. Once there, scroll down and click on 'Start submission'.

To submit a proposal via the electronic submission system, you will need to have an EU Login account and ensure that your organisation is registered as a beneficiary.

Description :

Five European anti-cancer charities (Fundación científica Asociación Española Contra el Cáncer (Spain); The Anticancer Fund (Belgium); Fondation ARC (France); Kom op tegen Kanker (Belgium); Dutch Cancer Society (The Netherlands)) are joining forces to stimulate international research on rare cancer drug development. The focus of this joint international call, the ATTRACT-Call, is on late phase (2/3) clinical trials on rare cancer drugs. Improving treatment for rare cancers as well as bringing drug development to the next developmental stage are two of the current target goals.

All information regarding the ATTRACT-call, including background, scope, application requirements, preferences and recommendations, review procedure, timelines, funding conditions and estimated budgets can be found in the Guidelines for Applicants (available on KWF website)