'Health, demographic change and well-being' – Clinical Studies
Health in H2020 across the Pillars Industrial Technologies Societal Challenges Excellent Science § European Research Council § Leadership in enabling and § Health, demographic change industrial technologies § Fron%er research by the best and wellbeing individual teams § ICT, nanotechnologies, § Food security, sustainable materials, biotechnology, agriculture, marine and manufacturing, space § Future and Emerging mari=me research & the Technologies bioeconomy § Access to risk finance § Collabora%ve research to open § Secure, clean and efficient new fields of innova%on § Leveraging private finance and energy venture capital for research § Smart, green and integrated and innova%on § Marie Skłodowska Curie ac=ons transport § Opportuni%es for training and § Climate ac=on, resource § Innova=on in SMEs career development efficiency and raw materials § Fostering all forms of innova%on in all types of SMEs § Inclusive, innova=ve and § Research infrastructures reflec=ve socie=es (including e-infrastructure) § Ensuring access to world-class § Secure socie=es facili%es European Ins=tute of Innova=on and Technology (EIT) Spreading Excellence and Widening Par=cipa=on Science with and for society Joint Research Center (JRC) 2
STRUCTURE OF THE PROGRAMME: WHERE HEALTH could fit? ERC GROUP of SC1, 2, 3, 7.. INDIVIDUAL Researchers/ RESEARCHER actors doing doing High risk/ fron%er collabora%ve Research mul%disciplinary research INDIVIDUAL ONE or more RESEARCHER SME developing HEALTH MSCA SME Instrument targe%ng dev. of solu%ons close research career and to market training GROUP of GROUP of researchers/actors researchers/actors doing research on doing basic/visionary but feasible research Key enabling NMP-b on technological Technologies FET aspects ICT Materials
Pubblicazione del Work Programme SC1 – 2018-2020 hLp://ec.europa.eu/research/par%cipants/data/ref/h2020/wp/2018-2020/main/h2020- wp1820-health_en.pdf
BHC-01-2019: Understanding causative mechanisms in co- and multi- morbidities (RIA) BHC-02-2019: Systems approaches for the discovery of combinatorial therapies for complex disorders (RIA) BHC-07-2019: Regenerative medicine: from new insights to new applications (RIA) BHC-10-2019: Innovation Procurement: Next generation sequencing (NGS) for routine diagnosis (PCP) BHC-22-2019: Mental health in the workplace (RIA) BHC-25-2019: Demonstration pilots for implementation of personalised medicine in healthcare (Innovation action)
Tempi di pubblicazione, le scadenze, l’uso del single o doppio stage? Ø Previs% bandi SINGLE STAGE e DOPPIO STAGE* Call 2018 2019 2020 Opening Deadline Opening Deadline 6 Feb 2018* 2 Oct 2018* To be 1 Beeer Health and care, 7 Nov 2017 4 SeL 2018* 26 Jul 2018 16 Apr 2019* defined economic growth and sustainable health systems DG RTD 18 Apr 2018 16 Apr 2019 26 Jul 2018 14 Nov 2018 2 Digital transforma=on in Health 7 Nov 2017 24 Apr 2018 16 Oct 2018 24 Apr 2019 and Care DG Connect 3 Trusted digital solu=ons and 7 Nov 2017 24 Apr 2018 26 Jul 2018 14 Nov 2018 Cybersecurity in Health and Care DG Connect
Clinical Studies • Why? What? • Template – Essential information about clinical studies • Do’s and don’ts – key issues for evaluation • Status of recruitment sites • Deliverables 1 0
EU-funded Clinical Studies – Why? • Bringing innovations to patients and markets • Providing evidence to impact clinical practice and improve patient care • Critical mass (e.g. rare diseases, stratified approaches) • Maximise recruitment through EU or international collaboration • Increase robustness of data • Multidisciplinary expertise 1 1
Clinical Studies – What do we fund? Scope, methodology, nature of the intervention, disease and target group Adults Off-patent trials Children Regenerative Repurposing trials Elderly therapies Paediatric trials Gender Rare diseases Drug, surgery, Non- radiotherapy, QoL communicable trials Phase I diseases Medical devices and Phase II Infectious companion Phase III diseases diagnostics trials Observational Quality of life Comparative studies interventions effectiveness trials Palliative care 4
Clinical Studies – What do we fund? > 340,000 patients recruited 165 Projects, 286 CTs , € 1.1 billion Phase I : 16% Phase I/II : 23 % Phase II : 21% Phase II/III : 5 % Phase III : 6 % Phase IV : 1 % Horizon 2020: around 50% of SC1 projects include clinical studies! 1 3
Clinical studies – applicability/ definition • A ‘clinical study ’ … any clinical research involving a substantial amount of work related to the observation of, data collection from, or diagnostic or therapeutic intervention on multiple or individual patients or study subjects. It includes but is not limited to clinical studies and clinical trials in the sense of the EU Clinical Trials Directive (2001/20/EC) and the Regulation (EU 536/2014). • Broad, inclusive definition! 1 4
Participant portal – one–stop shop •Call topics •NCPs •Expert registration •Documents •Project officers' list for questions •FAQs •Rules for participation •Upload project reports http://ec.europa.eu/research/participants/portal
Template PURPOSE Essential information about clinical studies 1 │ APPLICABILITY • providing structured information to experts for evaluation • giving applicants the chance to provide detailed information about clinical studies without page limitations • providing necessary information to request 'unit costs' • mandatory for certain single-stage and second-stage topics (listed in the template itself), if a clinical study is included But: no eligibility criterion, no disadvantage when information • provided in other part of proposal Rather: more and more appreciated (applicants, evaluators) as • an opportunity for structured information Available under 'call documents' (http://ec.europa.eu/research/participants/data/ref/h2020/other/legal/templ/h2020_tmpl-clinical- studies_2018-2020_en.pdf) and in submission system 1 6
Template SCOPE Essential information about clinical studies │ • Ethical considerations have to be addressed in the respective separate section • Risks and contingency plans have to be addressed in the respective section of the proposal (part B.3.2 and table 3.2.a) … If contingency plans are not outlined in the proposal (and the grant agreement), your grant agreement might be terminated and/or the EU contribution significantly reduced if a study cannot proceed as planned. "Extensions of project duration can generally not be granted in H2020. Significantly delayed key study milestones (e.g. 'first patient/first visit') might lead to the termination of the grant agreement." 1 7
Template UPDATES Essential information about clinical studies │ 1.2.2 Primary and secondary endpoint(s) Includes now: Explain how patient priorities/preferences have been or will be taken into account in the proposed study (e.g in relation to selection of design, endpoints, study populations etc.). • This is not a request to provide letters of support. • Patient priorities/preferences should be taken into account appropriately during and for the project planning and design of the clinical studies. • A short but comprehensive summary of the strategy/approach should be included in this sub-section. 9
Template UPDATES Essential information about clinical studies │ 3. Regulatory status and activities 1. Regulatory / ethics status Request for specification included: if the clinical study falls under Regulation EU No 536/2014 (Clinical Trials Regulation), Regulation EU No 2017/745 (Medical Devices) or Regulation EU No 2017/746 (In-Vitro Diagnostics). 2. Scientific advice / protocol assistance New sub-section, request for concise, but comprehensive information about the planned activities 3. Qualification advice New sub-section, request for concise, but comprehensive information about the planned activities 10 • Relevant e.g. for biomarker research
Do’s and don’ts – key issues for evaluation • The recruitment planning has to be sufficiently detailed and realistic! • Contingency measures have to be appropriate (ensuring that delays can be compensated) and realistic! • If FIM / FIH (First in HuMan) application is intended in a clinical study, the descriptions of the ' FIM / FIH package ' (safety pharmacology / toxicology) has to be exhaustive, allowing experts to evaluate the risk of the project to (not) achieve the required ethics and regulatory approvals. • If study medication is required sufficient information has to be provided allowing to evaluate if the planning is realistic. 1 1
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