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Introduction to DRIVE - Javier Diez Domingo

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DRIVE Annual Forum
17th -18th September 2018, Rome

Published in: Health & Medicine
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Introduction to DRIVE - Javier Diez Domingo

  1. 1. Acknowledgement DRIVE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777363, This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Introduction to DRIVE Acknowledgement DRIVE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777363, This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Javier Díez-Domingo, MD, PhD, DRIVE coordinator FISABIO-Public Health
  2. 2. Since 2017, the European Medicines Agency requires brand-specific influenza vaccine effectiveness results. EMA encourages industry to liaise with public health authorities who have experience in influenza effectiveness studies and who have implemented a functioning infrastructure to conduct multicentre studies
  3. 3. A sustainable study network for brand-specific influenza vaccine effectiveness studies in the EU A governance model for transparent, scientifically robust public-private partnerships is a public-private partnership launched by the Innovative Medicines Initiative in 2017 to establish:
  4. 4. is a partnership between the European Union and the European pharmaceutical industry to fund health research and innovation.
  5. 5. How to ensure adequate sample size for each brand? Where are the different brands used? How to manage a public-private partnership? Does the involvement of industry create issues of scientific independence? …
  6. 6. Main objectives A sustainable study network for brand-specific influenza vaccine studies in the EU A governance model for transparent, scientifically robust public-private partnerships
  7. 7. • Scientific independence and transparency in influenza vaccine effectiveness (IVE) studies • Timely, type/brand-specific IVE studies for all vaccines and risk groups across Europe • Information to support better influenza control and vaccination approaches • Confidence of European institutions in public-private partnership • Awareness of European citizens in benefit of vaccination Additional objectives
  8. 8. • Scientific independence and transparency in influenza vaccine effectiveness (IVE) studies • Timely, type/brand-specific IVE studies for all vaccines and risk groups across Europe • Information to support better influenza control and vaccination approaches • Confidence of European institutions in public-private partnership • Awareness of European citizens in benefit of vaccination Additional objectives
  9. 9. • Scientific independence and transparency in influenza vaccine effectiveness (IVE) studies • Timely, type/brand-specific IVE studies for all vaccines and risk groups across Europe • Information to support better influenza control and vaccination approaches • Confidence of European institutions in public-private partnership • Awareness of European citizens in benefit of vaccination Additional objectives
  10. 10. • Common understanding & overcoming barriers to collaboration between different stakeholders • Optimized data collection answering the needs of all stakeholders • Assuring the scientific integrity of the studies and transparent reporting of the results. • Robust studies, high methodological quality, regulatory requirements • Exchange and synergy with related initiatives • Novel methods for vaccine effectiveness evaluation • Increased awareness among European citizens of the use and benefits of influenza vaccines DRIVE contributions
  11. 11. DRIVE Forum General Assembly Quality Control & Audit Committee (QCAC) Coordination Team Independent Scientific Committee (ISC) WP7 IVE studies THL ISS Steering Committee (SC) WP5 Communi- cation THL SEQIRUS WP6 Project Management – FISABIO, SP WP4 Analysis & reporting P95 ABBOTT WP3 Study quality ISS SEQIRUS WP2 Study tools FISABIO GSK WP1 Governance model IRD SP WP8 Ethics Requirements– FISABIO, SP
  12. 12. Work Packages WP Title Lead partners WP1 Development of a governance model for joint influenza vaccine effectiveness studies in Europe IRD / SP WP2 Development of study tools FISABIO / GSK WP3 Evaluation of studies’ quality and feasibility ISS / SEQIRUS WP4 Framework for analysis and study reports P95 / ABBOTT WP5 Communication and dissemination of results THL / SEQIRUS WP6 Project management, coordination and sustainability FISABIO / SP WP7 Influenza Vaccine Effectiveness Pilot Studies THL / ISS WP8 Ethics requirements FISABIO
  13. 13. Quality assurance Study support application Ethics requirements Protocols Identification of vaccine brands Report template TOOLS& GUIDELINES FRAMEWORK Systematic review on bias & confounding Governance development Research agenda WP1 WP2 WP3 WP4 WP5 WP7 Alignment with regulators Interpretation of VE results Analytical methods WP8 IVE studies Communications
  14. 14. IVE studies (WP7) only involve non-industry partners Industry partners of DRIVE have no access to IVE study data They may review WP7 scientific deliverables & provide comments All comments provided in writing WP7 Quality Control & Audit Committee (QCAC) Independent Scientific Committee (ISC) WP7 IVE studies THL ISS
  15. 15. Test-negative design studies Cohort studies using databases Conducted independently in participating countries Anonymized / pseudonymized data submitted to DRIVE pooled analysis + Call for tender launched to look for novel and innovative IVE study approaches
  16. 16. Public organizations with established IVE studies Other research organizations Associate partners Research collaborators Annual call for tenders Review by DRIVE SC
  17. 17. IVE studies & sharing data DRIVE annual meetings Scientific discussion, publications Development of innovative methodology Associated Partners and Research Collaborators receive compensation for participation in DRIVE activities
  18. 18. An Independent Scientific Committee oversees the scientific deliverables and the transparency & neutrality of the process Hector Izurieta (FDA) Liz Miller (PHE) Mark Miller (NIH) Marianne van der Sande (RIVM) Stefania Salmaso ISC Quality Control & Audit Committee (QCAC) Independent Scientific Committee (ISC) WP7 IVE studies THL ISS
  19. 19. Final report on governance principles Generic post-authorisation development plan on VE IVE studies Study reports Key deliverables & milestones 2017 2018 2019 2020 2021 2022 Multi-stakeholder research agenda IVE interpretation guidelines Analysis on confounders & bias in IVE studies Electronic Study Support Application Evaluation of fulfilling regulatory requirements IVE study protocols Governance Standard Operating Procedures IMI technical audit Report on IVE knowledge gaps for future R&D
  20. 20. Please follow DRIVE at Twitter: @drive_eu And participate the discussion with the hashtag #DRIVEflu. The pilot year’s results are not finalized and therefore the content of some sessions is not public. The content of these sessions can not be quoted outside this meeting, including social media. This will be indicated at the start of the session. Information for the participants
  21. 21. www.drive-eu.org Acknowledgement DRIVE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777363, This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. info@drive-eu.org @drive_eu

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