Introduction

ERA PerMed fosters research and innovation activities that build close linkages between clinical research, computer science/medical informatics and research on ethical, legal and social aspects (ELSA) in the field of Personalized Medicine. This implies a wide range of multidisciplinary activities brought together by different stakeholders from academia, clinical/public health research and private partners such as small and medium-sized enterprises (SMEs), policy makers, regulatory/health technology assessment (HTA) agencies and patients/patient organisations.

The overarching goal is to improve disease prevention and disease management, based on broader and more efficiently characterised and defined patient stratification, diagnostics and tailored treatment/prevention protocols for both patients and individuals at risk of disease.

Call Objectives:  

The overall objectives of the call are to:

- Support translational and transnational research projects in the field of PM;

- Encourage and enable interdisciplinary collaborations towards the implementation of PM, combining clinical research with bio-informatics components and research on relevant ethical, legal and social aspects. Additionally, pre-clinical and health economic research can be included if the added value is outlined;

- Encourage collaboration between academia (research teams from universities, higher education institutions, public research institutions, research centres), clinical/public health research (research teams from hospital/ public health, healthcare settings and other healthcare organisations), private partners e.g. SMEs (small and medium-sized enterprises) as well as policy makers, regulatory/HTA agencies and patient representative organisations.

Call Options:

The JTC2021 is constructed around the following three research areas in order to ensure the

development of specific PM approaches, taking into account the major aspects for their

successful implementation in the health systems:

(1) "Translating Basic to Clinical Research

and Beyond",

(2) "Data and Information and Communication Technology (ICT)" and

(3)"Research towards Responsible Implementation in Healthcare":

Each proposal MUST address the modules 1B "Clinical Research", 2 "Towards Application in Healthcare" and 3B "Ethical, Legal and Social Aspects". Inclusion of modules 1A "Pre-clinical Research" and 3A "Health Economic Research" is optional. Their added value to the proposal and the mandatory modules has to be clearly described.

Small-scale exploratory clinical studies are within the scope of the call. ERA PerMed can support exploratory clinical studies, including those with a smaller number of patients/volunteers that aim to demonstrate the feasibility of early diagnosis and/or stratification of patients for existing drugs, for example. Exploratory clinical studies submitted to this call should be designed to allow further scalability, although their escalation is not part of this joint call. Proposals must adhere to the requested budget and time frame of the planned studies. Studies should be finalised within the 3-year funding period of the call. ERA PerMed will only fund those parts of the proposed study that address the aims of the call.

ERA PerMed supports exploratory clinical studies that assess the viability of a future study (e.g. clinical trial):

• Pilot studies in which the future definitive study, or parts of it, including the randomisation or non-randomisation of participants, is conducted on a smaller scale (piloted) to assess its feasibility. Pilot studies should resemble the main (future) study in the relevant respects, including the assessment of the primary outcome.
• Feasibility studies that are not pilot studies, such as those in which the investigators attempt to answer a question about whether some element of the future intervention is deemed feasible. In contrast to pilot studies, in this kind of study, no part of the future study is being conducted on a smaller scale. Feasibility studies that are not pilot studies serve to estimate important parameters that are needed to design the main study.

Duration: Maximum 36 months

Budget: Eligible costs and funding provisions may vary according to the respective funding organisation's regulations. Applicants must refer and adhere to their own specific national regulations and scientific remits as detailed in the National Announcements.

Eligibilty

Only transnational projects will be funded.

• Each consortium submitting a proposal must involve at least three partners eligible for funding from three different countries whose funders participate in the call (see list above).
• At least two partners out of the minimum three eligible project partners of the consortium must be from two different EU Member States or Associated Countries.
• The project coordinator must be eligible to be funded by his/her regional/national participating funding organisation.
• The maximum number of partners per project at the pre-proposal stage is six. At the full-proposal stage, the consortium may be expanded to up to seven partners in total only by inclusion of a partner from an underrepresented country.
• Within one consortium, no more than two partners from the same country participating in the call will be accepted, including those partners with their own funding.
• Partners not eligible for funding by one of the organisations participating in this JTC (e.g. from non-funding countries or not fundable according to the regional/national regulations of the participating funding organisations) may participate in projects.

Joint research proposals may be submitted by applicants belonging to the following categories:

A. Academia (research teams working in universities, other higher education institutions) or research institutes;

B. Clinical/public health sector (research teams working in hospitals/public health and/or other healthcare settings and health organisations). Participation of clinicians (e.g. medical doctors, nurses) in the research teams is encouraged;

C. (Industry) Private partners, e.g. SME15 (small and medium-sized enterprises).

Consortia submitting applications to this call are strongly encouraged to include partners from different categories (A, B and C) in line with the crosscutting/multidisciplinary nature of the call, where the aim is to include partners at different levels in the value chain.

Participating Countries: Austria; Belgium; Brazil; Chile; Denmark; Egypt; Estonia; Finland; France; Germany; Hungary; Israel; Italy; Latvia; Luxemburg; Norway; Norway; Panama; Poland; Romania; Spain; Sweden; Turkey.

There is a two-stage submission process. Applicants are strongly advised to contact their national representative as soon as possible in order to confirm their eligibility with their respective funding organisations.

Pre-proposals must be submitted using the electronic proposal submission link.

- Deadline for pre-proposals: 4/03/2021

- Deadline for full proposals: 17/06/2021 (only for pre proposals invited to second stage).

In case of interest, please contact lnorton(ELIMINAR)@fsjd.org