Gonzalo Calvo [email protected]/wp-content/uploads/2017/01/01_GCalvo... ·...
Transcript of Gonzalo Calvo [email protected]/wp-content/uploads/2017/01/01_GCalvo... ·...
Gonzalo [email protected]
SCReN
Created by the Instituto de Salud Carlos III (National Institute of Health) thorough a nacional public call
When?: January 2014
What?: Decentralize (Transversal) Network (No legal
personality)
Where?: 11 regions
Who?: 29 Clinical trial units, with 86 professionals(contracted with the funds) & the active collaboration of more than 210 specialists.
SCReN: Decentralized Network Structure
SCReNNOT LEGAL ENTITY
UICEC
UICEC
UICEC UICEC
UICEC UICEC
UICEC UICEC
UICEC 2
UICEC 4
UICEC 5
UICEC 3
UICEC 1
UICEC 6
UICEC 7
UICEC 1
UICEC 2
UICEC 3
UICEC 4
29 UICECPFV
PMBGD
PRM
Executive Committee
Profiles
16
33
46
56 60
1
5 69 8
0
5
9,511,5
10
02 2
46
0
10
20
30
40
50
60
70
Contratación por Programas
PRM
PFV
PGDE
PCyF
Innovation in Investigators Initiated Clinical Trials
ScientificHigh
Quality Ideas
INVESTIGATOR LEADERSHIP
Best PracticesSite
collaboration
Flexible Structure
Risk adaptation
Education
NETWORK Def: An association of individuals having a common interest, formed
to provide mutual assistance, helpful information.
CTUs “more experienced”
CTUs “less experienced”
Sr. PM Jr. PM
SCReN in Numbers
PatientsMore than 7.000
UICECS29Years3
Contracts110
Clinical Trials60
Enrolment sites636
Project Selection Process
Principal Investigator Initial Proposal
CTU: SupportMethodological supportManagement feed back
Budget calculation
Final Proposal Ready for Evaluation
Validation(Programs)
Evaluation1 member executive committee
2 evaluators (CTU proposals)
AcceptanceQuestions & Answers
Decline
Evaluators:
A SCReN decision
Evaluator panel: Representing proposed by every Clinical Trial
Unit
Main Criteria:
• Methodology
• Feasibility
• Collaboration
2 evaluators per project+
member of the executive committee
Evaluation Milestones
2014
2015
2016
60 days
10 days
10 days
4 months
1 month
3 Weeks
Validation Evaluation
Project Incorporation
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12
1514
Studies: Long commitment
ECRIN General Presentation
Supporting Clinical Trials Across Borders
First and last name| Date
About ECRIN
Overview of ECRIN Activities
Role of European Correspondents (EuCos)
Agenda
ECRIN
Overview
A non-profit organisation with the legal status of European Research Infrastructure Consortium (ERIC)
Mission: support the conduct of multinational clinical trials across Europe
Diverse support areas: trial management, preparation, protocol evaluation, quality assurance, etc.
9 Member and Observer Countries: Czech Republic, France, Germany, Hungary, Italy, Norway, Portugal, Spain, Switzerland (additional countries about to join)
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Why ECRIN?
Context
Need for multinational trials
Greater access to patients, medical expertise and appropriate facilities Higher methodological standards Shared costs, tools and procedures Potential for broad implementation of research outcomes Avoidance of duplication of trials
But several obstacles to multinational trials
Infrastructure interoperability, regulation, ethical review, insurance, contracts, management, cost models, funding, languages, etc.
ECRIN as a solution
Provides support to sponsors in investigator-initiated trials A pathway through Europe’s fragmented health and legal systems
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Values and Approach
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We collaborate with diverse partners in Europe and beyond to address the key bottlenecks to multinational clinical trials
We fill a gap in the European clinical research landscape
Through our collaborative approach, we aim to support trials that have the greatest public health impact
We can work across a wide range of clinical trial areas (e.g., medicines, medical devices, nutrition, surgical procedures)
We respect the highest ethical and methodological standards
History At A Glance
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2004: ECRIN created; began 1st project (EU Framework Program 6, FP6) on strategy development involving six countries
2006: 2nd project (FP6) on tools development with 12 countries; listed on European Strategy Forum on Research Infrastructures (ESFRI) roadmap
2008: 3rd project (FP7) with 14 countries to develop ECRIN’s business plan and legal status
2012: 4th project (FP7), ECRIN Integrating Activity (ECRIN-IA), with 23 countries to structure national scientific partners and build their capacity to manage multinational trials
2013: Awarded ERIC status
2016: Listed as an “ESFRI Landmark” on the updated ESFRI Roadmap
EuCos, Core Team, National Partners
Organisation: Distributed Infrastructure
European Correspondents (EuCos)
Implement work in-country in coordination with national partners
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Core Team
Develops ECRIN’s strategy, common tools and procedures
Supports EuCos
National Partners (networks of clinical trial units, CTUs)
Manage trials in-country and provide services to ECRINHost EuCos
National Scientific Partners
Organisation
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: ISS (Istituto Superiore di Sanità) / ItaCRIN
Norway: NorCRIN (Norwegian Clinical Research Infrastructure)
Portugal: PtCRIN (Portuguese Clinical Research Infrastructure Network)
Spain: SCReN (Spanish Clinical Research Network)
Switzerland: SCTO (Swiss Clinical Trial Organisation)
ECRIN Countries
Members, Observers and New Applicants
ECRIN Member Countries
ECRIN Observer Countries
Applicants
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Additional Partners
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Affiliate/international partners include: Therapeutic Innovation Australia Ltd (TIA)
Korea National Enterprise for Clinical Trials (KoNECT)
European Vision Institute Clinical Research Network
(EVICR.net) (Portugal)
National Center for Advancing Translational Sciences
(NCATS) at the National Institutes of Health (NIH) (USA)
Oswaldo Cruz Foundation (FIOCRUZ) (Brazil)
Foundation for Biomedical Research and Innovation
(FBRI) (Japan)
Collaborating Across Borders for Greater Impact
Collaboration with specialised centres and disease-networks in Europe and worldwide
About ECRIN
Overview of ECRIN Activities
Role of European Correspondents (EuCos)
Agenda
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Overview
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Support for multinational trial preparation, protocol review and management
Development of tools
Quality assurance and data centre certification
Participation in capacity building projects
Diverse Activities to Facilitate Multinational Clinical Research
Coordinated Support from Preparation to Implementation
Main Activity: Trial Support
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ECRIN Campus for Regulatory & Ethical Requirements Central resource covering 22
European countries and multiple study types. Use to:
Locate country-specific competent authorities and ethics committees
Consult summary of requirements in each country
Browse related documents
Tools to Facilitate Multinational Trials (1/2)
ECRIN Provides Tools to Address Regulatory & Ethical Issues
campus.ecrin.org
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Medical Device Outcome Measure Database Identifies relevant outcomes
for specific medical devices. Information on: Product names
Risk class
Disease
Body system
Intervention type, device category
Source publication
Tools to Facilitate Multinational Trials (2/2)
ECRIN Provides Tools to Measure Outcome & Assess Risk
Risk-Based Monitoring Toolbox Enables researchers to
create appropriate risk-based strategies Choose risk assessment,
monitoring adaptation, or study conduct tools to find related tool names, institutions where they are used, links, and feedback
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Quality Assurance & Data Centre Certification
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ECRIN has an internal quality management system
Promotes quality externally through, for example, the Data Centre Certification programme:
Identifies non-commercial CTUs in Europe that can provide safe, secure, compliant and efficient management of clinical research data
CTUs are tested for compliance with ECRIN data standards through on-site audits by an independent Certification Board
Promoting Quality Inside and Outside the Organisation
Capacity Building Projects
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ECRIN participates in capacity building projects to enhance multinational clinical research
Diverse in scope and stakeholders (Europe/international)
Current projects aim, for example, to establish shared services in biomedical areas, further develop infrastructure, and foster international cooperation in non-commercial trials
Outcomes benefit ECRIN-supported trials
Laying the Foundation for Improved Multinational Clinical Research
About ECRIN
Overview of ECRIN Activities
Role of European Correspondents (EuCos)
Agenda
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A Closer Look at the EuCos: Overview of Role
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Act as the link between the Core Team, other EuCos, national scientific partners, and trial stakeholders
Manage the ECRIN trial portfolio in-country, providing support during trial preparation, validation and/or implementation
Act as “Coordinating EuCo” (typically when trial sponsor is in their country) or “Participating EuCo” in multinational trials
Support During Preparation
Role in Managing the Trial Portfolio (1/3)
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Support investigators to prepare applications for
multinational funding: logistical and operational
components
Provide guidance on the services required for a trial,
and logistical and operational aspects: regulatory and
ethical issues, insurance, contracting, trial
monitoring, costs
Support During Validation
Role in Managing the Trial Portfolio (2/3)
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Provide assistance on applications for ECRIN scientific
and methodological evaluations
Coordinate logistical assessments:
Assess the availability/feasibility of services
Identify CTUs
Lead cost calculation for defined services
Support During Implementation
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Organise communication between the sponsor, ECRIN and CTUs
Coordinate the implementation and follow-up of services:
Manage contractual aspects (between sponsor, ECRIN Core Team, CTUs)
Coordinate the initiation of services by CTUs and follow up on service provision (according to trial tasks, timelines and procedures)
Provide assistance if issues arise between the sponsor and CTUs
If requested, provide operational trial management
Role in Managing the Trial Portfolio (3/3)
ECRIN experience in trial support
Since 2009
As of 2017, 40 European-funded trials
In 2016, 11 new trials funded
6 clinical trials (out of 16)
1 clinical trial
4 clinical trials
H2020 EXPERIENCE IN SPAIN
COORDINADOS
-LIVERHOPE
-ORTHOUNION
-HIVACAR
PARTICIPANTES-RESPINE (FR)-PROOF (DE)
Challenges
• Business Continuity . . .
• Project Funds Managment. . .
• UICECs selection
• Low enrolment rates . . .
• Lack of “Legal entity”. . .
• Salaries
Gracias