Multinational Clinical Trials in EU How NCAs can improve the system? Dr C. Bélorgey, Head of Clinical Trials Department Afssaps Chair of CTFG

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1 Multinational Clinical Trials in EU How NCAs can improve the system? Dr C. Bélorgey, Head of Clinical Trials Department Afssaps Chair of CTFG Bonn 30 April 2010

2 European CTs bodies (Competent Authorities) 1 European commission/ Ad Hoc CTs Experts working group CTD guidances 2 Databases (EMEA) Heads of Medicines Agencies/Clinical trials facilitation group (CTFG) Harmonisation Process and decision NCA NCA NCA NCA NCA CT Authorisations, CT safety, inspections and control NCA NCA

3 Harmonisation of CTs in EU : a step by step program 2 The European directive on CTs ( )

4 The clinical trials directive 3 Interventional clinical trials Medicinal products A common legal framework in 27 Member States Improved standards of subjects protection Better Quality : -clinical trials (GCP) -investigational MP (GMP) Procedures (CTA, ECs), time lines, documents (IMPD..) Exchange of information beetween Member States (2 data bases) Eudract EV-CTM

5 4 CTs in EU to CTs each year in EU 75% are in only one MS 25 % in more than one MS 10 % in more than 3 MS

6 Procedure for starting a clinical trial in EU 5 In each MS concerned Ethics committee Single positive opinion Sponsor 1. EudraCT Nb 2. CTA dossier Start of CT National Competent Authority Authorisation

7 Procedure for the conduct of the CT 6 In each MS concerned Eudravigilance S P O N S O R Substantial amendments SUSARs New events likely to Impact/security Annual safety report Authorisation Favorable opinion expedited Time-scales Time-scales National Competent Authority Ethics committee Suspension, Prohibition, modification of the CT : competent authority End of trial, results Time-scales EudraCT

8 Harmonisation in EU : a step by step program 7 The European directive on CTs ( ) The European Commission workshop on CTs (oct. 2007)

9 Results from 3 October 2007 European Commission workshop: Difficulty areas for MNCTs (NCAs) 8 Multinational CTAs Persistent non harmonisation as to : Requirements on CTA dossier, definitions, safety reporting, IMP/NIMP concept National assessments of CTAs Transparency A risk-based approach A basis for multiple sponsorship

10 Harmonisation in EU : a step by step program 9 The European directive on CTs ( ) The European Commission workshop on CTs (oct. 2007) The Road map initiative ( ) Impact analysis of CTD by the Commission, public consultation, road map (2010) Revision of EU legislation in 2011? Meanwhile, voluntary NCAs cooperation: the CTFG mandate and activities

11 The Clinical Trials Facilitation Group (CTFG) 10 Operational group Established by Heads of Medicines Agencies (HMA) Since 2004 Representation - 27 National Competent Authorities (NCAs), European Commission, European Medicines Agency - Chaired by France, co chaired by Germany - Meets 5 to 6 times per year + teleconferences Terms of Reference - Improve interactions between the NCAs, more coordination - Promote harmonisation of decisions on CTs, avoid divergent decisions - Get a common interpretation of regulatory aspects

12 11 CTFG progresses and actions New mandate Jan Within the current legal framework : - Coordonate or share scientific assessment of multinational CTs - Harmonise processes and practices - Develop data sharing and information systems - Communicate - with the aim to set up best practices between MS - and to propose changes or clarification of the guidelines.

13 CTA Assessment: What is required to NCAs by sponsors? Need to improve harmonisation of the administrative process Avoid : National CTA requirements National divergent decisions National approaches to SA Bureaucratic burden 2. Need to facilitate the administrative process Same CTA dossier A single repository An electronic submission Application in English 3. Need to improve the scientific review outcomes Better definition of the objectives of the review process A coordinated scientific decision on the same CT

14 13 Difficulties for NCAs - Different roles of NCAs and Ethics committees in each MS - Different scopes of assessment - Different experiences on scientific CTA assessment

15 14 Coordination of MN CTs scientific assessment by NCAs Build common assessment criteria and same approach Same objectives of the review process: subjects safety, IMP quality and safety, best time-frames 2008 A forum for scientific discussion CTA assessors networks Regular scientific exchanges Scientific meetings dedicated to specific technical issues (Q,NC,C) Data sharing : EU databases CTFG mail box Vitero system 2009 A standardised procedure for coordination of CTA assessment The voluntary harmonisation procedure (VHP) A simple administrative process Same application dossier, single repository, electronic submission, English mandatory

16 Improvement of exchange of information by NCAs through the EU databases 15 EUROPEAN DATABASES AVAILABLE TO NCAs, EUROPEAN COMMISSION AND EMEA EudraCT Functionalities European database of CTs Electronic handling, EudraCT number Content : - CTA application form - EC opinion+nca decision - End of CT, withdrawal - Inspections. - Electronic alerts :CTA refusals, withdrawals, GNA -Assessment reports sharing - Other functionalities - The European Public CTs registry project (2010) Eudravigilance CT module European database on Susars ; Electronic submission. Links/IMP coding Functionalities Safety analysis and reports

17 CTFG action plan Expand the VHP Input in new guidances Hope this will help sponsors. Thank you!