Agenda. About ECRIN Overview of ECRIN Ac4vi4es Increasing value

Transcription

1 Agenda About ECRIN Overview of ECRIN Ac4vi4es Increasing value

2 ECRIN Overview A non- profit organisa4on with the legal status of European Research Infrastructure Consor4um (ERIC) Mission: support the conduct of mul4na4onal clinical trials across Europe Coordinated services from prepara9on to implementa9on 9 Member and Observer Countries: Czech Republic, France, Germany, Hungary, Italy, Norway, Portugal, Spain, Switzerland (addi4onal countries about to join) 2

3 History At A Glance 2004: ECRIN created; began 1 st project (EU Framework Program 6, FP6) on strategy development involving six countries 2006: 2 nd project (FP6) on tools development with 12 countries; listed on European Strategy Forum on Research Infrastructures (ESFRI) roadmap 2008: 3 rd project (FP7) with 14 countries to develop ECRIN s business plan and legal status 2012: 4 th project (FP7), ECRIN Integra4ng Ac4vity (ECRIN- IA), with 23 countries to structure na4onal scien4fic partners and build their capacity to manage mul4na4onal trials 2013: Awarded ERIC status 2016: Listed as an ESFRI Landmark on the updated ESFRI Roadmap 3

4 Organisa9on: Distributed Infrastructure EuCos, Core Team, Na4onal Partners European Correspondents (EuCos) Implement work in- country in coordina4on with na4onal partners Core Team Develops ECRIN s strategy, common tools and procedures Supports EuCos Na9onal Partners (networks of clinical trial units, CTUs) Manage trials in- country and provide services to ECRIN Host EuCos 4

5 ECRIN - Organisa9on Na4onal Scien4fic Partners Czech Republic: CZECRIN Czech Clinical Research Infrastructure Network France: F- CRIN French Clinical Research Infrastructure Network Germany: KKSN Netzwerk der Koordinierungszentren für Klinische Studien Hungary: HECRIN Hungarian Clinical Research Infrastructure Network Italy: Is4tuto Superiore di Sanita (ISS), Rome Norway: NorCRIN Norwegian Clinical Research Infrastructure Portugal: PtCRIN Portuguese Clinical Research Infrastructure Network Spain: SCReN Spanish Clinical Research Network Switzerland: Swiss Clinical Trial Organisa4on (SCTO)

6 Addi9onal Partners Collabora4ng Across Borders for Greater Impact Collabora4on with specialised centres and disease- networks in Europe and worldwide Affiliate/interna4onal partners include: Therapeu4c Innova4on Australia Ltd (TIA) Korea Na4onal Enterprise for Clinical Trials (KoNECT) European Vision Ins4tute Clinical Research Network (EVICR.net) (Portugal) Na4onal Center for Advancing Transla4onal Sciences (NCATS) at the Na4onal Ins4tutes of Health (NIH) (USA) Oswaldo Cruz Founda4on (FIOCRUZ) (Brazil) Founda4on for Biomedical Research and Innova4on (FBRI) (Japan) 6

7 Agenda About ECRIN Overview of ECRIN Ac4vi4es Increasing value 7

8 Overview Diverse Ac4vi4es to Facilitate Mul4na4onal Clinical Research Support for mul4na4onal trial prepara4on, protocol review and management Development of tools Quality assurance and data centre cer4fica4on Par4cipa4on in capacity building projects 8

9 Main Ac9vity: Trial Coordinated Support 9

10 Tools to Facilitate Mul9na9onal Trials (1/2) ECRIN Provides Tools to Address Regulatory & Ethical Issues ECRIN Campus for Regulatory & Ethical Requirements Central resource covering 22 European countries and mul4ple study types. Use to: Locate country- specific competent authori4es and ethics commijees campus.ecrin.org Consult summary of requirements in each country Browse related documents 10

11 Tools to Facilitate Mul9na9onal Trials (2/2) ECRIN Provides Tools to Measure Outcome & Assess Risk Medical Device Outcome Measure Database Iden4fies relevant outcomes for specific medical devices. Informa4on on: Product names Risk class Disease Body system Interven4on type, device category Source publica4on Risk- Based Monitoring Toolbox Enables researchers to create appropriate risk- based strategies Choose risk assessment, monitoring adapta4on, or study conduct tools to find related tool names, ins4tu4ons where they are used, links, and feedback 11

12 Agenda About ECRIN Overview of ECRIN Ac4vi4es Increasing value 12

13 How to improve? Ques9ons relevant to clinicians, pa9ents Appropriate design and methods Accessible full publica9on Unbiased and usable report 13

14 ECRIN Scien9fic Board To assess/improve relevance and quality of projects to be supported by a publicly funded infrastructure Aimed at ensuring Transparency: registra4on, publica4on, data sharing, disclosure Real and relevant ques4ons: trial hypotheses Reliable answers: trial methodology ECRIN on board: early methodological support 14

15 Transparency Methodology 15

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17 Quality Assurance & Data Centre Cer9fica9on Promo4ng Quality Inside and Outside the Organisa4on ECRIN has an internal quality management system Promotes quality externally through, for example, the Data Centre Cer4fica4on programme: CTUs in Europe that can provide safe, secure, compliant and efficient management of clinical research data 17

18 Individual pa9ent- level CT data sharing Strong move towards data sharing of IPD from clinical trials Strong impact and benefit expected from secondary analyses of IPD Several policies/recommenda4ons for access to IPD developed and several repositories available for sharing of IPD CORBEL/ECRIN has provided up to date, detailed, broad in scope and applicable recommenda4ons suppor4ng the implementa4on of access to IPD from clinical trial Next steps are pilo4ng the recommenda4ons within ECRIN trials, discussing the recommenda4ons in the interna4onal context and suppor4ng the implementa4on of the recommenda4ons 18

19 Research for innova9ve methods to improve the process of clinical research comprehensively 19

20 Thank you! Any ques4ons?