ECRIN-TWG kick-off meeting Tenerife, October 31, 2006 01/12/2006 - - PowerPoint PPT Presentation

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ECRIN-TWG kick-off meeting Tenerife, October 31, 2006 01/12/2006 - - PowerPoint PPT Presentation

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ECRIN-TWG kick-off meeting Tenerife, October 31, 2006 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 1 Other regions Canada Sweden SweCRIN Denmark Ireland DCRIN EFGCP ICRIN UK UK-CRN EORTC and Germany other EU countries KKS

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01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 1

ECRIN-TWG kick-off meeting Tenerife, October 31, 2006

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01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 2

France CIC & UEC Spain SCReN Sweden SweCRIN Germany KKS Denmark DCRIN Italy IRFMN & CIRM Hungary HECRIN UK UK-CRN Other regions Canada Ireland ICRIN EFGCP EORTC and

  • ther EU countries

Aus, Bel, NL…

National networks of Clinical Research Centres / Clinical Trial Units

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01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 3

ECRIN, an ECRIN, an integrated integrated infrastructure infrastructure for for clinical clinical trials in trials in the the EU EU

  • ECRIN

ECRIN-

  • 1 (2004

1 (2004-

  • 2005) :

2005) : – – Identifying Identifying bottlenecks bottlenecks

  • ECRIN

ECRIN-

  • 2 (2006

2 (2006-

  • 2008) :

2008) : – – Preparing Preparing the the infrastructure infrastructure

  • ECRIN

ECRIN-

  • 3 (2008

3 (2008 -

  • > ) : FP7 ESFRI

> ) : FP7 ESFRI roadmap roadmap – – Preparation Preparation, construction , construction and and operation

  • peration of
  • f the

the infrastructure infrastructure supporting supporting multinational multinational clinical clinical trials in trials in the the EU EU

  • In line

In line with with expectations of FP7 expectations of FP7 ‘ ‘Innovative Innovative Medicines Medicines Initiative Initiative

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ECRIN ECRIN-

  • 1 (2004

1 (2004-

  • 2005) :

2005) : identifying identifying bottlenecks bottlenecks

ECRIN-RKP (FP6-funded):

  • > survey and comparative analysis on

1 - Structures and objectives of centres and networks 2 - Financing, sponsoring 3 - Ethics 4 - Legislation, regulatory affairs, insurance 5 – Adverse event reporting, drug dispensing 6 – Methodology, data management, data monitoring 7 - Quality management, SOPs, audits 8 - Communication, partnerships 9 - Study registers 10 – Education and careers

  • > reports on www.ecrin.org
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ECRIN ECRIN-

  • 2 (2006

2 (2006-

  • 2008) :

2008) : preparing preparing the the infrastructure infrastructure

ECRIN TWG (FP6 ECRIN TWG (FP6-

  • funded)

funded) TRANSNATIONAL WORKING GROUPS : TRANSNATIONAL WORKING GROUPS :

  • > Guidelines

> Guidelines and and procedures procedures 1 1 -

  • ethics

ethics 2 2 -

  • regulation

regulation 3 3 -

  • adverse

adverse event event reporting reporting 4 4 -

  • data management

data management 5 5 -

  • monitoring

monitoring 6 6 -

  • quality

quality assurance assurance –

– SOPs

SOPs 7 7 -

  • education

education

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Network Committee Advisory Board Co-ordination team

  • Ch. Kubiak
  • J. Demotes

European Correspondent National Network European Correspondent National Network European Correspondent National Network European Correspondent National Network MANAGEMENT Ethics-regulation-vigilance Data managt & monitoring Quality assurance Working Parties

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01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 7 ECR I N

Co o r d i n at i o n n at i o n al n e t w o r k Co o r d i n at i o n n at ion al n et w o r k Co o r d i n at i o n n at i o n al n e t w o r k Co o r d i n at i o n n at i o n al n e t w o r k Co o r d i n at i o n n at i o n al n e t w o r k

CR Cent r e CR Cen t r e CR Cent r e CR Cent r e CR Cent r e RC Cent r e R C Cent r e RC Cen t r e RC Cen t r e RC Cent r e RC Ce n t r e RC Cen t r e RC Cent r e RC Cent r e R C Cent r e RC Cent r e RC Cen t r e RC Cent r e RC Cent r e RC Cen t r e CR Cen t r e CR Ce n t r e CR Cent r e CR Ce n t r e CR CR Cent r e

CR = Clin ical Resear ch

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ECRIN Advisory Board ECRIN Advisory Board

  • European stakeholders and regulators

European stakeholders and regulators

  • 1

1 -

  • Representative of the Commission / IMI

Representative of the Commission / IMI

  • 2

2 -

  • Representative of European Medicines Agency (EMEA)

Representative of European Medicines Agency (EMEA)

  • 3

3 – – Representative of the Clinical Trials Facilitation Team Representative of the Clinical Trials Facilitation Team

  • Users and partners

Users and partners

  • I ndustry:

I ndustry:

  • 4

4 -

  • European Federation of Pharmaceutical Industries and Associatio

European Federation of Pharmaceutical Industries and Associations ns (EFPIA)/IMI (EFPIA)/IMI

  • 5

5 – – EuropaBio EuropaBio (representing the biotechnology SME sector) (representing the biotechnology SME sector)

  • Public sponsors and scientific agencies:

Public sponsors and scientific agencies:

  • 6

6 -

  • European Science Foundation (ESF)

European Science Foundation (ESF)

  • 7

7 -

  • Europe & Developing Countries Clinical Trials Programme (EDCTP)

Europe & Developing Countries Clinical Trials Programme (EDCTP)

  • Scientific associations and networks:

Scientific associations and networks:

  • 8

8 -

  • Paediatrics: representative of the TEDDY Paediatric network of

Paediatrics: representative of the TEDDY Paediatric network of excellence excellence

  • 9

9 -

  • European Organisation for Research and Treatment of Cancer (EOR

European Organisation for Research and Treatment of Cancer (EORTC) TC)

  • Patients

Patients’ ’ associations: associations:

  • 10

10 -

  • European AIDS Treatment Group (EATG)

European AIDS Treatment Group (EATG)

  • 11

11 -

  • European Association for Rare Diseases (EURORDIS)

European Association for Rare Diseases (EURORDIS)

  • Partner in communication:

Partner in communication:

  • 12

12 -

  • Orphanet

Orphanet

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Network Network committee committee

  • Denmark

Denmark : :Ch Ch Gluud Gluud

  • France : G Chêne, J

France : G Chêne, J Demotes Demotes

  • Germany

Germany : : Ch Ch Ohmann Ohmann

  • Hungary

Hungary : C : C Farsang Farsang

  • Ireland : P

Ireland : P Meulien Meulien

  • Italy

Italy : S : S Garattini Garattini, N , N Fabris Fabris

  • Spain

Spain : X Carn : X Carné é

  • Sweden

Sweden : P : P Lafolie Lafolie

  • United

United Kingdom Kingdom : P : P Selby Selby

  • Canada : JP Collet

Canada : JP Collet

  • EFGCP : JP

EFGCP : JP Tassignon Tassignon

  • EORTC ?

EORTC ?

  • Meetings

Meetings and and teleconferences teleconferences

  • Vote (

Vote (including including for extension, budget, for extension, budget, amendments amendments) )

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ECRIN ECRIN-

  • 2 (2006

2 (2006-

  • 2008) :

2008) : 7 7 working working groups groups

1 1 -

  • ethics

ethics 2 2 -

  • regulation

regulation 3 3 -

  • adverse

adverse event event reporting reporting 4 4 -

  • data management

data management 5 5 –

– monitoring

monitoring 6 6 -

  • quality

quality assurance assurance –

– SOPs

SOPs 7 7 –

– education

education

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ECRIN working party members ECRIN working party members

  • Two per country, one responsible for the

Two per country, one responsible for the deliverables, supported by a substitute. The deliverables, supported by a substitute. The European Correspondent participates in every European Correspondent participates in every working party. working party.

  • Additional input for the industry, regulators,

Additional input for the industry, regulators, ethics committees, partner ethics committees, partner organisations

  • rganisations

(EFGCP, EORTC), and from the (EFGCP, EORTC), and from the paediatric paediatric field field

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ECRIN ECRIN-

  • 2 : deliverables

2 : deliverables

Guidelines and procedures for multinational Guidelines and procedures for multinational studies, posted on the studies, posted on the internal internal website, website, and updated. and updated.

  • Clinical studies on medicinal products :

Clinical studies on medicinal products : sept sept 2006 2006 -

  • >

> june june 2007 2007

  • Other clinical research :

Other clinical research : -

  • >

> june june 2008 2008

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ECRIN TWG budget ECRIN TWG budget

700.000 € over 2 years, start date October 1st 2006

  • 80% in december 2006 (45 days after signature of the

contract)

  • 20% 45 days after final scientific and financial report

Follow-up of expenses by the coordination with the support

  • f EU correspondents

One single audit certificate at the end of the project Expenses should fit with the financial plan, however changes are allowed if justified For AC cost models, salaries should correspond to personnel specifically hired for the project.

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ECRIN ECRIN-

  • 3 (2008

3 (2008-

  • ) :

) : Integrated Integrated services to multinational services to multinational studies studies (1) (1)

  • Flexible,

Flexible, integrated integrated services (one services (one-

  • stop shop) in

stop shop) in the the conduct conduct

  • f
  • f the

the study study 1 1 -

  • interaction

interaction with with ethics ethics commitees commitees 2 2 -

  • interaction

interaction with with competent competent authorities authorities, , regulatory regulatory affairs affairs 3 3 -

  • drug

drug dispensing dispensing 4 4 -

  • adverse

adverse event event reporting reporting 5 5 -

  • data management

data management 6 6 -

  • data monitoring

data monitoring 7 7 -

  • management of

management of biological biological samples samples

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ECRIN ECRIN-

  • 3 (2008

3 (2008-

  • ) :

) : Integrated Integrated services to multinational services to multinational studies studies (2) (2)

  • Information

Information and and consulting consulting during during the the preparation preparation of

  • f the

the study study 1 1 -

  • Methodology, protocol review and adaptation of study

Methodology, protocol review and adaptation of study protocol to protocol to transnational transnational constraints constraints 2 2 -

  • Ethical review

Ethical review 3 3 -

  • Meta

Meta-

  • analysis

analysis 4 4 -

  • Centre selection, stimulation of patients

Centre selection, stimulation of patients’

’ enrolment

enrolment 5 5 -

  • Cost evaluation

Cost evaluation 6 6 -

  • Funding opportunities

Funding opportunities 7 7 -

  • Biostatistics

Biostatistics 8 8 -

  • Data safety and monitoring committees

Data safety and monitoring committees 9 9 -

  • Insurance

Insurance

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ECRIN ECRIN-

  • 3

3 and and FP7 ESFRI FP7 ESFRI roadmap roadmap

Design Design studies studies 70M 70M€ € ESFRI (500M ESFRI (500M€ €), ), 35 35 projects projects, 6 in , 6 in BMS, BMS, ECRIN ECRIN Preparation Preparation and and construction / construction / upgrade (30% ) upgrade (30% ) Later Later ??? ???

Networking Networking activities activities, , joint joint research research projects projects, , access access activities activities

6 in 6 in biomedical biomedical science (BMS) science (BMS)

health health priority priority-

  • IMI

IMI

Access (60% ) Access (60% ) to to existing existing infrastructures infrastructures Open call Open call Targeted Targeted call call

FP7 infrastructures FP7 infrastructures 1.850M 1.850M€ €

1 – preparation (ESFRI) : EU 2 – construction (GMP facilities, datacentres) EU+member states 2bis – access to research projects : EU open call ?

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ECRIN: ECRIN: preparation preparation step step, 3 , 3-

  • 4

4 years years

  • Building /

Building / strengthening strengthening institutional institutional sponsor sponsor capacity capacity and and the the coordination of national networks in EU countries coordination of national networks in EU countries

  • Extension to

Extension to other

  • ther national (or

national (or EU EU-

  • wide

wide) infrastructures ) infrastructures networks networks

  • Design of

Design of datacenters datacenters, , and and prototypes prototypes

  • Design of,

Design of, and and connection connection with with GMP GMP facilities facilities ( (with with EATRIS) EATRIS)

  • Education, training,

Education, training, mobility mobility

  • Communication : International

Communication : International Clinical Clinical Trials Trials day day (May 20th) (May 20th)

  • Legal

Legal status status, , contracts contracts with with sponsors sponsors

  • Website

Website

  • Cost

Cost of

  • f access

access ( (industry industry, SME, , SME, academia academia) ), , financial financial rules rules, ,

  • sustainability

sustainability, business plan , business plan

  • Support to pilot

Support to pilot projects projects

  • Support to

Support to the the connection connection of

  • f disease

disease-

  • oriented
  • riented networks

networks across across the the borders borders

  • FP7

FP7 Innovative Innovative Medicines Medicines Initiative Initiative

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Communication Communication with with patients patients and and citizens citizens (FP7 SSA ?) (FP7 SSA ?)

  • ‘

‘International International Clinical Clinical Trials Trials Day Day’ ’ on May 20

  • n May 20
  • Discussion forums on

Discussion forums on evidence evidence-

  • based

based medicine medicine with with

– – Patients Patients – – Investigators Investigators – – Sponsors Sponsors – – Ethics Ethics Committees Committees – – Competent Competent Authorities Authorities

  • How to

How to foster foster

– – Active participation of patients Active participation of patients and and education education – – Protection of participants Protection of participants and and safety safety of

  • f treatments

treatments – – Quality Quality of data,

  • f data, transparency

transparency and and unbiased unbiased report report

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Bottlenecks Bottlenecks identified identified in in the the Innovative Innovative Medicines Medicines Initiative Initiative (IMI) (IMI) Strategic Research Agenda Strategic Research Agenda

Discovery research Preclinical develop. Translational medicine Clinical develop. Pharmaco- vigilance Predictive pharmacology Predictive toxicology

Efficacy Safety

Identification

  • f biomarkers

Validation of biomarkers Risk assessment with regulatory authorities Patient recruitment

Knowledge Management Education & Training

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Infrastructures for preclinical R&D: toxicology models and databases, biopharmaceutical manufacturing facilities

Research networks Investigators networks Patients’ registries

Infrastructures for multinational clinical research : clinical research centres, cohorts, biobanks, databanks, imaging Infrastructures for drug discovery: high throughput ‘omic’ facilities, in silico and animal models

cancer brain diabetes inflammation infection EU-wide infrastructures networks Clinical (ECRIN) Preclinical Drug discovery EU-wide disease-oriented networks

FP7 FP7 Innovative Innovative Medicines Medicines Initiative : Initiative : Europe Europe-

  • wide

wide infrastructures infrastructures and and disease disease-

  • oriented
  • riented networks

networks