Two-stage calls
Call deadline – first stage – October 04, 2016
Call deadline – second stage – April 11, 2017
SC1-PM-02-2017: New concepts in patient stratification
Proposals should deliver novel concepts for disease-mechanism based patient stratification to address the needs for stratified or personalised therapeutic interventions. The proposals should integrate multidimensional and longitudinal data and harness the power of -omics, including pharmacogenomics, systems biomedicine approaches, network analysis and of computational modelling. The new concepts of stratification should be validated in pre-clinical and clinical studies taking into account sex and gender differences. Applicants are encouraged to actively involve patient associations. The proposals should consider regulatory aspects of clinical practice and commercialisation opportunities. Proposals should focus on complex diseases having high prevalence and high economic impact.
SC1-PM-07–2017: Promoting mental health and well-being in the young
Proposals should develop population-oriented primary prevention15 interventions to promote mental well-being of young people and assess them for their effectiveness. The interventions should build on but may go beyond existing state-of-the art knowledge on biological, psychological and social determinants of mental well-being such as societal, cultural, work life, lifestyle, epidemiological, economic and environmental perspectives. The proposals should aim at increasing resilience and mitigating the impact of biological, psychosocial and environmental risk factors. The target group should include young up to 25 years (or a subgroup there of), which is an age limit often used as many severe disorders start in this period.
The research design should be developed by means of a multidisciplinary approach and involve the young themselves and other relevant stakeholders. Innovative approaches in involving the young and gathering their inputs for the design of the intervention should be considered. The interventions should use a holistic approach, taking gender and health inequality aspects into account, in increasing resilience and empowering the young. The interventions to be developed should reflect the diversity of the different countries and regions in Europe and beyond. The research should pay particular attention to ethical issues. The interventions should be assessed for mental well-being outcomes as well as the economic and social benefits and impact on reducing inequalities. These analyses of impact and effectiveness should be presented in quantitative as well as qualitative terms, in a gender disaggregated way where relevant. The results should be disseminated throughout Europe and beyond in order that the evidence generated is fully exploited.
SC1-PM-08–2017: New therapies for rare diseases
Support will be provided to clinical trials on substances where orphan designation has been given by the European Commission, where the proposed clinical trial design takes into account recommendations from protocol assistance given by the European Medicines Agency, and where a clear patient recruitment strategy is presented. Clinical trials may focus on a range of interventions with an orphan designation, from small molecule to gene or cell therapy, may include novel interventions and/or repurposing of existing and known interventions. The intervention must have been granted the EU orphan designation at the latest on the date of the full proposal call closure. A concise feasibility assessment justified by available published and preliminary preclinical or clinical results and supporting data shall also be provided. Appropriate plans to engage with patient organisations, Member States health authorities and considerations of efficacy/potential clinical benefit as well as early indication on health economics should be integrated in the application. In addition to the clinical trial, proposals may also include limited elements of late stage preclinical research and/or experimental evaluation of potential risks which must be complementary/contribute to the clinical trial(s) carried out within the proposal. The centre of gravity must clearly be the clinical trial(s). The participation of SMEs is encouraged.
Selected proposals shall contribute to the objectives of, and follow the guidelines and policies of the International Rare Diseases Research Consortium, IRDiRC (www.irdirc.org).
SC1-PM-10–2017: Comparing the effectiveness of existing healthcare interventions in the adult population
Proposals should compare the use of currently available preventative or therapeutic (pharmacological as well as non-pharmacological) healthcare interventions in adults19. While there is no restriction on the diseases or interventions to be the focus of proposals, preference will be given to proposals focusing on interventions with high public health relevance and socio-economic impact, i.e. interventions addressing conditions that are particularly frequent, may lead to co-morbidities, have a high negative impact on the quality of life of the individual and/or are associated with significant costs or where savings can be achieved. A cost effectiveness analysis must be included. Given the focus on existing interventions, proposals will aim to contribute to improve interventions, take decisions about the discontinuation of interventions that are less effective or less cost-effective than others, and make recommendations on the most effective and cost-effective approaches. A comprehensive array of clinical and safety parameters, as well as health and socio-economic outcomes (e.g. quality of life, patient mortality, morbidity, costs, and performance of the health systems) for chosen populations should be assessed. 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. Randomised controlled trials, pragmatic trials, observational studies, large scale databases and meta-analyses may be considered for this topic. Where relevant the study population should address gender as well as socio-economic differentials in health and/or any other factors that affect health equity.
One-stage calls
Call deadline – January 31, 2017
SC1-PM-15-2017: Personalised coaching for well-being and care of people as they age
Proposals should develop a proof of concept of radically new solutions for a personalised "virtual coach", building upon intelligent ICT environments, access to relevant physiological and behavioural data, new forms of accessible interaction based on tangible user interaction concepts, open platforms and emotional computing. Usability and ease of user interaction should be essential design elements of the "coach".
The "coach" should provide personalised advice, guidance and follow-up for key age related issues in daily life which impact the person's ability to remain active and independent, for example diet, physical activity, risk avoidance, preventive measures, lifestyle and activity management, leisure, social participation and overall wellness. The goal should be to preserve physical, cognitive, mental and social well-being for as long as possible and to facilitate interaction with carers (where relevant).
Solutions should build on and apply multi-disciplinary research and include intelligent algorithms beyond state-of-the-art capable of reasoning, autonomous learning and adaptation to personal needs, emotional and behavioural patterns, conditions and preferences as well as the users' living environment and their social connections. Solutions should be integrated seamlessly in existing every-day activities and provide desired information in fast and efficient manner. Attention theft by ICT (consuming too much of the user's time) should be avoided.
Call deadline – March 14, 2017
SC1-PM-16–2017: In-silico trials for developing and assessing biomedical products
Proposals will develop innovative in-silico trials for designing, developing and assessing drugs, radiation and other biomedical and bioactive products. They will build on comprehensive biological and biomedical knowledge management and advanced modelling paradigms in order to be able to simulate the individual human physiology and physiopathology at the biological levels relevant for the biomedical product under study (at the cell level, tissue level or organism level) and the interaction with the product, thus taking into account the variability among individuals (for example, molecular pathways, cellular microenvironments, microbiota, genetics, gender characteristics, behaviours, comorbidities, development, diet). Virtual populations of individual patients will be built for simple or composite diseases, for example, from the patient-specific models by variations of different parameters and will allow simulating the action of the products and predicting the treatments outcomes in order to develop a personalised medicine approach. The proposed in-silico trials will be the result of a multidisciplinary effort (e.g. within the fields of computational modelling, systems biology, tissue mechanics, biology, pharmaceutics, medicine) and will also explore and inform of the reasons of fails and suggest improvements. To help establishing such computer simulated trials, measures for validation (human trials, animal studies, validation in cell cultures) of the in-silico models shall also be included in the proposed projects. The benefit for human health, environment and animal welfare should be analysed and quantified. Contact with regulators and consideration of the regulatory framework issues are highly recommended.
SC1-PM-17–2017: Personalised computer models and in-silico systems for well-being
Proposals should aim at the development of new integrative dynamic computer-models and simulation systems of acceptable validity, with the potential to being reused, build on open service platforms and with application in well-being, health and disease. The projects have to support computer modelling and simulations able to aggregate various information sets e.g. molecular, biochemical, medical imaging, social, lifestyle, economic, occupational, microbiome, environmental, developmental, psychological, gender etc. into robust predictors for resilience in coping with and overcoming challenges and stresses and for recovery after challenges and illness. They will process and apply individual/patient-specific information in a multi-scale approach required for integrating information at a certain biological level within a wider context (at least one biological level from molecule to entire body). Proposals will focus on multi-disciplinary research in medicine, SSH and ICT and should take advantage when relevant of existing large databases in clinical medicine, biomedical or occupational research, environmental sciences, Social Sciences and Humanities (SSH), so enabling and facilitating the accumulation and relinking of complex and heterogeneous data collections. The models integrated in these multi-scale and multi-disciplinary approaches will have their predictive capability validated by state-of-the-art clinical and/or laboratorial studies and/or against large health registries. Whenever relevant, proposals will integrate data collected over time in order to inform on individual trajectories with periods of well-being and periods of illness and on the heterogeneity of resilience and recovery that can be different during the individual lifetime.
SC1-PM-19–2017: PPI for uptake of standards for the exchange of digitalised healthcare records
Proposals should address as primary aim public procurement of innovative solutions (PPI) to facilitate the deployment of an eHealth infrastructure taking into consideration the European eHealth Interoperability Framework and EU guidelines adopted by the eHealth Network. The PPI(s), and any accompanying innovation activities in particular by participating procurers themselves to facilitate the uptake of newly developed solutions, should focus on clear target outcomes such as allowing the sharing of health information, the use of semantically interoperable Electronic Health Records (EHRs) for safety alerts, decision support, care pathways or care coordination. The scope of the PPI(s) is to specify, purchase and deploy innovative ICT based solutions which can deliver sustainable, new or improved healthcare services across organisational boundaries while implementing eHealth interoperability standards and/or specifications (e.g. EN13606, HL7, Continua Alliance, IHE...).
Call deadline – April 11, 2017
SC1-PM-03–2017: Diagnostic characterisation of rare diseases
The aim of this research should be to apply genomics and/or other –omics and/or other high-throughput approaches for the molecular characterisation of rare diseases in view of developing molecular diagnoses for a large number of undiagnosed rare diseases. Undiagnosed rare diseases may range from a group of unnamed disorders with common characteristics to a phenotypically well described disease or group of diseases with an unknown molecular basis. Genetic variability due to geographical distribution and/or different ethnicity should be taken into account as well as genotype-phenotype correlation whenever applicable. In addition, age, sex and gender aspects should be included where appropriate. This large-scale proposal should promote common standards and terminologies for rare disease classification and support appropriate bioinformatics tools and incentives to facilitate data sharing. Existing resources should be used for depositing data generated by this proposal. Molecular and/or functional characterisation may be part of the proposal to confirm diagnosis. The proposal should enable and foster scientific exchange between stakeholders from countries and regions with different practices and strategies of rare disease diagnostics.
The selected proposal shall contribute to the objectives of, and follow the guidelines and policies of the International Rare Diseases Research Consortium IRDiRC (www.irdirc.org).
SC1-PM-20-2017: Development of new methods and measures for improved economic evaluation and efficiency measures in the health sector
SC1-HCO-03–2017: Implementing the Strategic Research Agenda on Personalised Medicine
Proposals should pool the necessary financial resources from the participating national (or regional) research programmes with a view to implementing a joint call for proposals resulting in grants to third parties with co-funding in this area.
This call should aim at implementing a key area of the PerMed Strategic Research Agenda and be complementary with other funding programmes and activities at European and international level. Proposers are encouraged to include other joint activities including additional joint calls without EU co-funding. This work should be informed by the output of the coordination and support action envisaged in topic SC1-HCO-05-2016 - Coordinating personalised medicine research, without duplicating any of its work.
The proposed ERA-NET should demonstrate the expected impact on national and transnational programmes as well as the leverage effect on European research and competitiveness, and should plan the development of key indicators for supporting this. Participation of international partners is highly encouraged.
SC1-HCO-07–2017: Global Alliance for Chronic Diseases (GACD)
SC1-HCO-08–2017: Actions to bridge the divide in European health research and innovation
Any type of activities that can help less performing countries and regions to build capacities and exploit opportunities to eventually increase their participation in EU funded collaborative projects can be supported. Beneficiaries of the activities should be low performing Member States/regions that have identified health R&I as a priority in their Research and Innovation Strategies for Smart Specialisation (RIS3). Applicants shall seek synergies with European Structural and Investment Funds, the operational programmes and support from managing authorities.
The proposals will propose concrete measures for tackling structural barriers to health research and innovation, including those related to capacity, skills, policy, regulatory environment, and economic and socio-cultural factors including gender equality issues and gender dimension in research content.
