Public - Private Partnerships in Europe and ENCePP Initiative

Transcription

1 Public - Private Partnerships in Europe and ENCePP Initiative Henry Fitt Section Head, Co-ordination & Networking, Pharmacovigilance and Risk Management European Medicines Agency 22nd Annual EuroMeeting March 8-10, 2010 Monaco

2 PROTECT Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium PROTECT Web Page (hosted by EMA): Contact: PROTECT Management Support protect_support@emea.europa.eu

3 PROTECT key information is a public-private European collaborative project led by the Agency. The consortium has 17 public (academia/regulators/smes) and 12 private (Pharma) partners. funded by the Innovative Medicines Initiative Joint Undertaking (IMI JU). total funding over 20 million, 50% in-kind contributions from the participating EFPIA companies. will run over 5 years (start date is Sept 2009)

4 PROTECT - Goal The goal of PROTECT is to strengthen the monitoring of benefit-risk of medicines in Europe by developing innovative methods that will enhance the early detection and assessment of adverse drug reactions from different data sources (clinical trials, spontaneous reporting and observational studies). These methods will be tested in real-life situations.

5 Objectives The objectives and deliverables in PROTECT will be addressed using 6 distinct Work Packages (WPs), each developing certain specific scientific components of the overall Project. An additional WP will be responsible for the governance and management of the Project. Work Package Work Package title 1 Project management and administration 2 Framework for pharmacoepidemiological studies 3 Methods for signal detection 4 New tools for data collection from consumers 5 Benefit-risk integration and representation 6 Validation studies involving an Extended Audience 7 Training and communication

6 WP2 Framework for PE studies WPco-L: UU, Pfizer WP3 Methods for signal detection WPco-L: UMC, BSP WP4 New tools for data collection WPco-L: EMEA, HLU WP5 Benefit/risk integration and representation WPco-L: Imperial, ME Project Plan The PROTECT work programme WP7 Training & communication WPco-L: FICF, Novartis Pharma WP6 Validation studies involving an Extended Audience WPco-L: PGRx (LASER), SARD WP1 Project management & administration Coordinator: EMA Deputy Coordinator: GSK

7 WP2: Framework for Pharmacoepidemiological Studies Objective To develop, test and disseminate methodological standards for the design, conduct and analysis of pharmacoepidemiological studies, applicable to different safety issues using different data sources Example Develop study protocols for selected drugs and key AEs associations Provide guidelines on how to identify public health impact of AEs Investigate discrepancies in results between databases and explore differences with other data sources Evaluate identified signals from signal detection strategies applied in WP 3 in electronic health records

8 WP3: Methods for Signal Detection Objective To develop new methods - and assess existing ones - for signal detection from spontaneous reports, electronic health records (EHR) and clinical trials Example Provide advice on good signal detection (SD) practices Develop new methods for SD from spontaneous reports Implement and examine the value of screening methods in EHR Evaluate the performance of disproportionality analysis based on novel grouping tools applied to adverse reactions

9 WP4: New Tools for Data Collection from Consumers Objective To develop (in several EU countries) modern methods of data collection directly from consumers in their natural language, including using webbased screens, text messaging and computerised telephone interviews Example To assess the feasibility, efficiency and usefulness of these tools To pilot approaches between data sources To measure the acceptability of these methods and assess the transferability of data collection methods in different countries and for other conditions

10 WP5: Benefit-Risk Integration & Representation Objective To develop methods for use in benefit-risk assessment including both the underpinning modelling and the presentation of the results, with particular emphasis on graphical methods. Example Identify, characterise and test methods of collating data on benefit and risks from various data sources, strengths of evidence Test and compare modelling approaches that would allow continuous benefit-risk modelling along the lifecycle of the products and support decision making Develop methods of graphical expression of the benefits and risk of the medicinal products for use by different stakeholders

11 Work Packages 6 & 7 WP6 Objective To validate methods developed in WP2 to 5 in various data sources owned or managed by Consortium Partners or members of the Extended Audience WP7 Objective To identify training opportunities and support training programmes in the fields addressed by PROTECT

12 Dissemination of Results The Project will generate reports providing standards and recommendations which will be widely disseminated through: PROTECT web portal It will include a webpage accessible to the general public where relevant deliverables for public use will be posted Publications Most deliverables of the project will be produced in the first instance as reports delivered to the IMI JU and they will also be published and disseminated through the appropriate mediums. ENCePP network The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance is an Agency-led project intended to further strengthen the postauthorisation monitoring of medicinal products in Europe. The results of the PROTECT programme will be made available to all ENCePP members.

13 Management structure WP2 WP3 WP4 WP5 WP6 WP7 Consortium Assembly All participants Main Governance Bodies Steering Committee (Deputy) Coord and Alternates WP co-leaders Coordinator & Deputy Coordinator External Advisory Board External independent experts Project Management Support Team WP1 Managing Entity of the IMI JU Funding

14 External Advisory Board Name Affiliation Expertise De Vries Corinne, PhD Department of Pharmacy and Phamacology, Pharmacoepidemiology University of Bath, UK Trevor Gibbs, MD Former Head of Global Pharmacovigilance and Product Safety, GSK, UK Pharmacovigilance Health Outcomes Public Health David Haerry European AIDS Treatment Group (EATG), Brussels, Belgium Public Health Patients preference Vicky Hogan, MSc Associate Director General, Marketed Health Benefit-risk assessment Products Directorate (MHPD), Health Canada, Michael Lewis, MD EPES Epidemiology, Pharmcoepidemiology and Pharmacoepidemiology Systems Research GmbH, Berlin, Germany Allen Mitchell, MD Slone Epidemiology Center, Boston, USA Perinatal epidemiology Marcus Müllner, MD Gerald Dal Pan, M.D., M.H.S. Munir Pirmohamed, MD Samy Suissa, PhD Head of AGES PharmMed (Austrian Medicines and Medical Devices Agency), Austria Director Office of Drug Safety, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA Department of Pharmacology and Therapeutics, University of Liverpool, UK Division of Epidemiology/Biostatistics, McGill University, Montreal, Canada Pharmacoepidemiology Benefit-risk assessment Clinical epidemiology Pharmacovigilance Pharmacovigilance Drug development Public Health & Risk management Pharmacology Pharmacovigilance Biostatistics Pharmacoepidemiology

15 PROTECT Key Participants Public (17) Agency (Co-ordinator) Danish Medicines Agency (DKMA) Spanish Medicines Agency (CEIFE) MHRA WHO-UMC INSERM GPRD IAPO FICF (Barcelona) Mario Negri Institute University of Munich University of Groningen University of Utrecht Imperial College London University of Newcastle PGRx Outcome Europe EFPIA (12) GSK (Deputy Co-ordinator) Sanofi- Aventis Roche Novartis Pfizer Amgen Genzyme Merck Serono Bayer Schering Astra Zeneca Lundbeck NovoNordisk

16 ENCePP European Network of Centres for Pharmacovigilance & Pharmacoepidemiology ENCePP Web Page (hosted by EMEA): Contact: PROTECT Management Support

17 ENCePP (European Network of Centres for PhV & Pharmacoepidemiology) Capacity building Agency-led project to bring together the available expertise and research experience in the fields of PhEpi and PhV scattered across Europe in a Network of Excellence, [research and medical-care centres, healthcare databases, electronic registries and existing networks]. The aim is to further strengthen the post-authorisation monitoring of medicinal products in Europe by facilitating the conduct of high quality, multi-centre, independent post-authorisation studies focusing on safety and benefit:risk.

18 ENCePP-Structure & main bodies WG Research Institutions WG Data Sources & Multisource Studies Steering Group ENCePP Secretariat Governance Inventories ENCePP Research Resources WG Research Standards & Guidance WG Transparency & Independence EU Data Sources EU Research Institutions DB 1, DB 2, DB 3, C 1, C 2, C 3,

19 ENCePP study In principle, all PhEpi / PhV studies whose Lead Investigator belongs to an entity included in the ENCePP Inventory of resources, and that fulfill the CORe requirements

20 CoRe requirements Code of Conduct: Compliance with the rules of the ENCePP Code of Conduct (Checklist & Declaration) Methodological Research Standards (MRS): Application of MRS (Checklist) e-register of Post-Authorisation Studies: Registration in the Register before study start The signed Declaration and Checklists and the study protocol shall be provided to the ENCePP Secretariat before the study commences.

21 Code of Conduct to ensure transparency and promote scientific independence in the conduct of studies. Essentially a charter of rights and obligations covering protocol agreement, data ownership, publication of results, Public consultation protocol, non-encepp studies, role of funder, conflicts of interest

22 Checklist of MRS Purpose is i) to stimulate researchers to consider important epidemiological principles when writing a study protocol, ii) to promote awareness and transparency regarding study methodologies and design 10 Sections 1. Research question 2. Study population 3. Study design 4. Data sources 5. Exposure measurement 6. Endpoint definition and measurement 7. Biases 8. Analysis plan 9. Quality assurance and feasibility 10. Ethical issues

23 Current Status WG ENCePP Research Standards & Guidance WG Transparency & Independence WG ENCePP Research Centres WG Data Sources & Multi-source Studies Minimum set of research standards & MRS Checklist ENCePP Seal Code of Conduct Focus on centres Registry of post-authorisation studies Focus on data sources mid 2010 Inventory of Resources Checklist Q Guidance Q Adoption Q Available for centres, currently being populated

24 Other Initiatives FDA Sentinel Active electronic safety monitoring system, complements existing safety monitoring systems Enable FDA to access existing automated healthcare data by partnering with data holders (e.g. insurance companies with large claims databases, owners of electronic health records, government agencies, others) Data sources maintained by their owners

25 Other Initiatives HC/SC DSEN Drug Safety and Effectiveness Network Enable research - link researchers through virtual network Create a national agenda of research based on priorities identified by decision-makers, Provide funding for research to assess the risks and benefits of drug products that are on the market Has 3 major components Linked centres of excellence Oversight committee Coordinating office Hosted by Canadian Institute of Health Research (CIHR)

26 Merci!!! ENCePP Web Page (hosted by EMEA): Contact: Henry Fitt