Datum objave: 20.07.2018. 18:33

Poziv za dostavljanje aplikacija u okviru programa Horizon 2020 za digitalna mjerenja neurodegenerativnih i imunoloških bolesti

TOPIC : Digital endpoints in neurodegenerative and immune-mediated diseases

Topic identifier:IMI2-2018-15-06

Publication date:18 July 2018

Types of action:IMI2-RIA Research and Innovation action

DeadlineModel: two-stage

Opening date: 18 July 2018

Deadline: 24 October 2018 17:00:00

2nd stage Deadline: 15 May 2019 17:00:00

Time Zone : (Brussels time)

Topic Description

Specific Challenge:

Neurodegenerative movement disorders (NMD) and immune mediated inflammatory diseases (IMID) can cause considerable disability and morbidity in spite of the availability of approved treatments. Recent estimates suggest that neurodegenerative disorders are becoming one of the fastest growing costs for healthcare systems. Movement disorders, in particular Parkinson's disease (PD), affect about 1.2 million European citizens, a number set to double by 2050 While rarer, the burden of Huntington's disease can be up to 5 times higher than that of PD patients.

Digital technology, in particular remote monitoring systems, if properly implemented and validated, could provide a critical help in improving measurements of efficacy by increasing sensitivity and precision, reducing variability, and enhancing their ecological validity making them closer to the actual unmet needs of patients. This project will develop a technology platform to collect and analyse sensor/generated datasets, principally high resolution passively and actively collected digital measurements, i.e. actigraphy, socialisation parameters and momentary self-reported assessments, mainly using (but not limited to) wearables and smartphone sensors and apps.

Scope:

Subtle impairments in accomplishing daily activities are sometimes reported among the first signs of a disorder that will progressively develop towards more severe disabilities for individuals affected with NDD and IMID. Identifying the ADLs that first or more consistently are affected by the disorders and tracing their progression using original digital solution is a key aspect of the present project. In fact, advances in micro-sensors and mobile technologies have the potential to enable seamless, continuous, objective measurements of symptoms and disabilities, providing more precise and higher frequency data collection. The early identification of impairment and the possibility to follow its worsening with precision and reliability are essential tools for assessing the effects of novel treatments that should target the disorder in its early phases. In fact, if the disorders progress beyond a certain point, the disabilities may not be reversible, justifying early interventions.

Expected Impact:

Digital transformation of clinical and real-world measures of ADL / quality of life measures relevant to patients and care-givers will give deeper and more detailed insights into how diseases progress and cause disabilities in patients, which, in turn, will enable development of interventions that better address these clinical deficits and disabilities.

Digital endpoints when combined with patient self-reported outcomes and other traditional clinical measures will provide a more valid and complete assessment of patient and care-giver impact of disease and their treatments.

Digital transformation of clinical and real-world endpoints will enable larger and more inclusive clinical trials and reduce patient burden thus allowing assessment of interventions in more diverse and representative populations.

Use of passive digital technologies will increase the efficiency of clinical trials, enabling faster clinical development and a reduction in the time taken to bring new therapies to patients. These technology enabled endpoints with passive data collection will make larger and longer follow-on studies to assess real world impact of therapies on patients possible, thus enabling more effective value driven health care decision making.

It is expected that, in the long run, this project will enable the development and evaluation of more effective therapies for patients thus improving outcomes for patients and reducing cost for all stakeholders.

Applicants should also demonstrate how they will impact on the competitiveness and industrial leadership of Europe by, for example, engaging suitable SMEs.

Topic conditions and documents

Please read carefully all provisions stated below before the preparation of your application.

The IMI2 JU 15th Call for proposals topics text as well as the Call Conditions are available here.  

The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information : 

1.   Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.

2.   Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.

Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.

3.   Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.

4.   Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.

Signature of grant agreements: maximum 3 months from the date of informing successful applicants.

5.   Proposal templates, evaluation forms and model grant agreements (MGA):

IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):

Proposal templates are available after entering the submission tool

Standard evaluation form

IMI2 Model Grant Agreement

Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !

6.   Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.

Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.

Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement. 

Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.

7. Additional documents:

Summary of the most relevant provisions for participating in IMI2 actions

3rd Amended IMI2 Annual Work Plan 2018

IMI2 Regulators Guidance tool for researchers

IMI JU derogation to H2020 Rules for Participation  

Horizon 2020 Rules for Participation 

Horizon 2020 Regulation of Establishment

Horizon 2020 Specific Programme

https://ec.europa.eu/research/participants/portal/desktop/en/opportunities/h2020/topics/imi2-2018-15-06.html