demotes ecrin antalya november 09 [salt...
TRANSCRIPT
1
20th National Pharmacology Congress of the Turkish Pharmacological Society
Antalya, November 4th 2009
European Clinical ResearchInfrastructures Network
Jacques [email protected]
www.ecrin.org
ECRIN
Pan-European, distributedinfrastructure providingintegrated services to multinational clinical researchin the EU:
- access to patients throughout the EU
- despite the fragmentation of health and legislative systems
- support to investigators and sponsors in multinational studies
European Clinical ResearchInfrastructures Network
2
BMS-ESFRI Roadmap
2006
2008
INFRAFONTIERINSTRUCTELIXIRECRINBBMRIEATRIS
BSL-4BBMRCOpenScreenEuroBioImaging
3
ECRIN, a distributed infrastructure for clinical trials in the EU
• ECRIN-1 (RKP, 2004-2005) : Identifying bottlenecks
• ECRIN-2 (TWG, 2006-2008) :Design of the infrastructure
• ECRIN-3 (PPI, 2008 - 2011) : ESFRI roadmap infrastructuresupporting multinational clinical trials in the EU
NNC
NNC
NNC
NNC
NNC
NNC
NNC
NNC
ECEC
EC
EC
ECEC
EC
EC
Coordination
ECRIN Management Office
GMPCRC
CRC
CRC
DM
CRCCRC = Clinical research centreDM = Data centre EC = European CorrespondentGMP = GMP facility for biotherapy NNC = National Network Coordination
4
Referenzpathologie
Germany
13 „Coordinating Centers“ for Clinical Trials3 associated centres (Regensburg, LMU Munich,Hannover)
Central Office in Cologne
6 sites with an integrated pediatric module(PAED-Net):Freiburg, Heidelberg, Cologne, Leipzig, Mainz, Münster
Permanent cooperation partner:Surgical network (CHIR Net) represented by: Study centre of the German Surgical Societynationwide network
+ Regensburg
+ München
+ Hannover
Bichat
Henri Mondor(94 Créteil)
Pitié-Salpêtrière
Necker Enfants Malades/HEGP
Robert Debré
Saint-Louis
Saint-Antoine
HEGP
Les 15-20
CochinPasteur
IGR/Curie (Villejuif/Paris
)
Saint-Pierre
Ile de la Réunion
CIC-P (25)
CIC-CE (9)
CIC-BT (11)
Lille
Rennes
Nantes Tours
Nancy
Strasbourg
Lyon
MontpellierMarseille
Bordeaux
Toulouse
Grenoble
Rouen
Saint-Etienne
Dijon
Brest
Clermont-Ferrand
Besançon
CIC-TI (8)
Garches
Poitiers
Limoges
Cayenne
Pointe-à-Pitre
Fort-de-France
54 54 ClinicalClinical Investigation Centres Investigation Centres withwith 8 main 8 main specialisationsspecialisations((CardiologyCardiology, , DiabetologyDiabetology, , GastroGastro--hepatologyhepatology, Neurosciences, , Neurosciences, PaediatryPaediatry, , ThrombosisThrombosis, Vaccines, and , Vaccines, and OncohaematologyOncohaematology))
France
5
UK
Management
Legal status
ECRIN Management Office(Coordination and European
Correspondents)
Structure Developmentof services
QA Unit +Working parties
Design & Construction
Pilot Projects
Network Committee
Governance
FinancialPlan
Education
CapacityBuilding
Extension
Communication
Ethics
Regulation
Vigilance
Monitoring
Data centres
GMP Facilities
MinistriesFunding AgenciesNetwork committee
Scientific Board(independent experts and
ECRIN representatives)
StakeholdersRegulatorsUsers/ PartnersScientific agenciesScientific networksPatient’s associations
Project Development
Board
AdvisoryBoard
Joint StrategicBoard
ESFRI-BMS ccordinators
ECRIN-3
6
ECRIN-PPI Work Packages
• WP2: selection of a legal status and of the governance structure • WP3: agreement on a financial plan leading to a long-term sustainability
during the construction step and the operation phase • WP4: survey on needs in terms of GMP facilities for biopharmaceuticals
and biotherapy, and their design • WP5: education programme for multinational clinical studies • WP6: extension to other EU member states • WP7: capacity building to help national networks fulfil the sponsor’s tasks• WP8: update and upgrade of the quality assurance system • WP9: internal and external communication • WP10: accreditation of data centres• WP11: support to pilot projects after evaluation by the scientific board
Flexible, integrated services in the conduct of the study
- Decentralised1 - interaction with ethics committees2 - interaction with competent authorities3 - participant recruitment and investigation4 - drug dispensing5 - circulation and storage of blood and tissue samples6 - study monitoring
- Centralised7 - adverse event reporting8 - data management – data centres9 - GMP manufacturing of biotherapy products
7
Information and consulting duringthe preparation of the study
- Practical information1 - Ethical requirements 2 - Regulatory requirements3 - Insurance4 - Centre selection5 - Cost evaluation6 - Funding opportunities
- Methodology7 - Systematic review, meta-analyses, and trial sequential analyses8 - Methodology, protocol design9 - Biostatistics10 - Data safety and monitoring board
Consulting
8
Support/services
Management
Legal status
ECRIN Management Office(Coordination and European
Correspondents)
Structure Developmentof services
QA Unit +Working parties
Design & Construction
Pilot Projects
Network Committee
Governance
FinancialPlan
Education
CapacityBuilding
Extension
Communication
Ethics
Regulation
Vigilance
Monitoring
Data centres
GMP Facilities
MinistriesFunding AgenciesNetwork committee
Scientific Board(independent experts and
ECRIN representatives)
StakeholdersRegulatorsUsers/ PartnersScientific agenciesScientific networksPatient’s associations
Project Development
Board
AdvisoryBoard
Joint StrategicBoard
ESFRI-BMS ccordinators
ECRIN-3
9
NNC
Legal status : ERICmembers = national ministries
• transnational team involved on a full-time basis in multinational studies (EU coordination, EU correspondent, national hubs)
• national networks, whose activity remains mostly national, with varying status, and who are involved on a part-time basis in multinational activities
NNC
NNCNNC
NNC
NNC
NNCNNC
ECEC
EC
EC
ECEC
EC
ECCoordination
ECRIN Management Office
GMPCRC
CRC
New contacts
SpainSCReN
FranceInserm
GermanyKKS
UKUKCRN
IrelandICRIN
EORTC
ItalyCIRM & IRFMN
SwitzerlandUBern-SCRN
AustriaATCRIN
HungaryHECRIN
SwedenSweCRIN
FinlandFinCRIN
DenmarkDCRIN
Belgium
The Netherlands
Poland
Turkey
Portugal
Luxembourg
Croatia
Regional hubs ?
10
Procedure and criteria for connection of new hubs: WP6
• Connection will be open to a national co-ordination of clinical research infrastructures (clinical research centres / clinical trials units), or to a national co-ordination of clinical research networks, reaching the critical mass and representing the standard in their own country, able to provide support to clinical research projects in any medical field, for any category of clinical research. In addition, they should also receive a support from national ministries or funding agencies for their participation in the FP7 ECRIN-PPI project.
• Pending on these criteria, the network committee will decide on the connection of additional national networks.
• These new networks will also benefit from the capacity buildingprogramme (WP7) both before and after their connection to ECRIN,facilitating the setup of competencies to effectively support investigators and sponsors in multinational studies.
Procedure and criteria for connection of new hubs: WP7
• A capacity building programme will help strengthening the capacity of national co-ordination to perform sponsor’s tasks in EU-wide studies and to make the co-ordination of new national networks able to provide the full range of services proposed to investigators andsponsors.
• capacity to provide services for the conduct of the study : interaction with ethics committees, interaction with regulatory authorities,vigilance, drug dispensing, circulation of blood and tissue samples, study monitoring, data management, patients enrolment and investigation
• capacity to provide consulting, during the preparation of the study
• quality assurance system within the national centres and network reaching the requirements defined in WP8.
11
Structuring clinicalresearch in the EU
• Development of national networks and hubs• Development of multinational disease-oriented networks
– FP7 ENBREC• Funding to clinical research infrastructures (national / EU)• Funding to clinical research projects (national / EU)
• Communication with patients, citizens, stakeholders– International clinical trials’ day
• Pan-EU platform for Education and Training– IMI EMTrain
• Improvement of the legislative framework– ESF/EMRC Forward Looks– ICREL FP7 (Impact on Clinical Research of European Legislation)
Comparison of national requirementsEC CA Sponsor Insurance AER
12
CTs performed before and after the CTD implementation
-2000
0
2000
4000
6000
8000
10000
Medicinalproducts
Medicinaldevices
Surgicalprocedures
Radiotherapy Otherinterventions
Observational
20032007Changes
Workload before and after CTD implementation
0
1
2
3
4
5
6
CTA to CA & EC Coordination andMonitoring
Pharmacovigilance Quality Assurance
FTE
Average/ organisation 2003Average/ organisation 2007Changes
13
Forward Looks ‘Investigator-Driven
Clinical Trials’
European Science FoundationEuropean Medical Research Councils (EMRC)
Recommendations : ranking
26
No. No. Recommendation Rank
21 4.1 Education and Training 124 5.1 Level of Funding 27 2.1 Risk-based approach 322 4.2 Careers 415 3.1 Clinical Trial Authorisations (CTA) Process 56 1.6 Large Scale IDCT 61 1.1 Categories of patient-oriented research 78 2.2 Management by risk-based approach 84 1.4 Commercial versus non-commercial trials 926 5.3 Models of Partnership 1016 3.2 Sponsor 1125 5.2 Prioritisation and mechanism of funding 129 2.3 Ethics Committee 1311 2.5 Insurance Requirements 135 1.5 Paradigm shift by biomedical breakthroughs 1514 2.8 Publication of Clinical Trials Results 1517 3.3 Investigational Medicinal Products (IMP) Requirements 17
18 3.4 Pharmacovigilance Reporting 1820 3.6 Project Management 1813 2.7 Data Storage Capacity 203 1.3 Phase I-II-III-IV categories 212 1.2 Interventional versus observational studies 2219 3.5 Pharmacovigilance Notification 2310 2.4 Adverse Event Reporting 2412 2.6 Intellectual Property Rights (IPR) 2523 4.3 Authorship 26
14
Innovative Medicines Initiative
Discoveryresearch
Preclinicaldevelop.
Translationalmedicine
Clinicaldevelop.
Pharmaco-vigilance
Predictive pharmacology
Predictive toxicology
Efficacy Safety
Identification of biomarkers
Validation of biomarkers
Risk assessmentwith regulatory
authorities
Patient recruitment
Knowledge ManagementEducation & Training
ESFRI Biomedical Research Infrastructures
EATRISTranslational
ELIXIRBioinformatics
INFRAFRONTIER Animal models
ECRINClinical Res.
BBMRIBiobanks
BiomolecularResources
INSTRUCTStructuralBiology
TargetId
TargetVal Hit Lead
LeadOptim Preclin Phase I Phase II
Research Discovery Development
Phase III
biobankingmodel validation
samplesdata
biomarkers
samplesdata
targetsbiomarkers
targets
15
National liaisonsProject Office(MUW and EFPIA)
WP 1: Management
WP 8: Learning and teaching concepts and methodology
WP 6: PhD programmes
WP 5: Master programmes
WP 4: AHEN *
WP 3: Mapping
WP 2: Strategy
WP 7: Continuing Professional Development
WP 9: Information, communication and dissemination
StrategicCoordination Board
Co-ordinators ESFRI-BMSRepresentatives T15-18
4 managing EFPIA membersChairs managing coordination board
Man
agin
gC
oord
inat
ion
Boa
rdW
P le
ader
san
d co
-lead
ers
External Advisory BoardNational ministries,
EU, NIH
Network CommitteePartner Universities
Patients AssociationsEUSJA, EMEA, ICH; Coordinators call 1-13
Teaching Experts
* Accreditation/Harmonisation/ Extension/National Implementation
IMI JU
Topics 15-18STEERING COMMITTEE
2 EFPIA members2 public consortium representatives
1
2
3
4
5
6
7
89
Thank you !