The DRIVE project, funded by the Innovative Medicines Initiative 2, aims to establish a platform for evaluating influenza vaccine effectiveness through a public-private partnership. The document outlines the governance structure, stakeholder engagement, and lessons learned from the project's first year, highlighting the importance of transparency, scientific integrity, and open data access. It also details the roles of various committees in overseeing site selection and data quality while emphasizing collaboration among diverse stakeholders to enhance the platform's impact on public health.

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.
A study platform
to generate brand specific
influenza vaccine effectiveness:
Governance, monitoring and evaluation
Laurence Torcel-Pagnon (Sanofi Pasteur) & Sam Nye (Confederation of Meningitis Organisations)
DRIVE Annual Forum
17th-18th July 2019, Helsinki

2. Our objective: decrypt the study platform governance …
How does it work
as a public-private partnership
What is set up to guarantee
transparency, scientific integrity and robustness
of the real life estimates
?

3. …And provide an interactive presentation
Present the study
platform governance
Discuss the governance
adaptations
Share first year lessons
learnt and testimonies
321

4. Agenda
Study platform
governance
How it works
Monitoring &
evaluation
framework
First year lessons
learnt
Survey results
&
Testimonies
Governance adaptations
Independent Scientific
Committee
&
Quality Control and
Audit Committee
2.45pm
How to increase
the study
platform
Open access
model
4:45pm

5. Participate in the survey and give your opinion!
DRIVE partners
ISC & QCAC members
Link to the SurveyMonkey
questionnaire received by
email
Please answer the questions on
Thursday 18th
DRIVE collaborators (study sites)
& external stakeholders
Connect with your mobile phone to
Klaxoon and get ready to answer the
questions during this presentation

6. 3 step approach
Presentation of study platform governance
On-line survey focusing on DRIVE Collaborators
(study sites) and external stakeholders
Key results sharing & open discussions

7. DRIVE: How does it work?
Video

8. Monitoring & evaluation framework
Governance
evaluation
Legitimacy/
coherence
Participation
/ openness
Transparency
Scientific
integrity / ethics
Accountability
/ responsibility
Efficiency
At the end of each season,
assessment made using:
reporting information,
feedback from partners,
committees‘ members and
sites, external stakeholders

9. 34 respondents out of the 68 participants of the last Annual meeting
13/20 collaborators/external stakeholders – 2/4 ISC – 2/4 QCAC – 17/40 DRIVE partners
40% of the collaborators/external stakeholders and 1 ISC member had questions/concerns
regarding the sites selection process
30% of DRIVE partners and 2 ISC members thought that the review process of the scientific
deliverables did not go well
More detailed information on DRIVE website
(Deliverable 5.5 Report on the collected feedback from Layer 1 Stakeholders)
Sharing first year lessons learnt: key survey results
Season 2017-18

10. Testimonies from public partners and sites
Season 2017-18
THL (Hanna)
ISS/Bambino Hospital (Caterina)
CIRI-IT (Giancarlo)
Medical university of Vienna (Monica)
Interviews conducted by Santu Leppilahti & Riia Järvenpää from THL

12. • Which stakeholder group describes your current organisation?
• In what country is your organisation located?
• How important do you think it is to provide annual brand-specific
influenza vaccine effectiveness estimates in Europe?
Survey – Introduction
DRIVE collaborators & external stakeholders

13. Independent Scientific Committee
Scientific assessment for sites selection
Scientific deliverables review
Quality Control and Audit Committee
First evaluation
The current study platform: what has changed?
Season 2018-19

14. 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.
Independent Scientific
Committee (ISC)
Marianne van der Sande & Liz Miller

15. In the interest of independence, rigour and
transparency of the brand specific IVE results,
the scientific leadership is supported by
an Independent Scientific Committee (ISC)
Evaluate and endorse the scientific
deliverables (protocols, statistical analysis
plan, pooled analysis report)
Provide advice on the study platform
governance and scientific communication
Perform a scientific evaluation of the sites
proposals
ISC role & mission
Season 2018-19
Hector Izurieta
Liz MillerMark Miller
Stefania
Salmaso
Marianne van
der Sande

16. 3->4->5 Second review done by Vaccine manufacturers ; consolidated
written comments submitted to ISC who advises on their integration
1->2->3 First review done by ISC

17. Sites selection in a 2 step approach
• All ISC members score each
proposal
• ISC share combined proposal
scoring and build consensus
for recommendations
Scientific
evaluation and
recommendations
• SC members perform
qualitative assessment for all
sites proposals
• SC meeting to share strategic
assessment and build
consensus for selection and
budget allocation
Strategic selection
and budget
allocation
ISC
SC

18. ISC: Scientific evaluation & recommendation
Topics / criteria
Max. number
of points
Choose one
a) Ability to adhere to DRIVE protocols (conventional study
design: TND, cohort) 15
b) Level of appropriateness for DRIVE (innovative study design)
Ability to capture brand-specific information 10
Estimated sample size (in terms of LCI for convientional designs and ILI for
innovative designs)
10
Scientific reliability of the laboratory testing or ability to send samples for DRIVE
testing
10
Expertise in conducting influenza vaccine effectiveness studies 5
Total 50

19. SC strategic selection and budget allocation
Topics / criteria References
ISC scientific
evaluation and
recommendation
Refer to ISC evaluation
Ability to fill gaps
and relevance for
pooled analysis in
DRIVE
Gaps table per vaccine
type/brand by age
(children, adult, elderly)
and setting (hospital,
GP)
New partner
PHI, organisation or
country
Cost-effectiveness
/ co-funding /
sustainability
Benchmark analysis + %
of co funding
Children
(0-17)
Adults
(18-64)
Elderly
(65+)
Special
population
Primary
care
Hospital
Mixed
Brands
available
(if known)
Nb of ILI/SARI & LCI

20. 1 February
15 April
13 May
31 May
20 June
26 June
15 sites proposals
ISC scoring ranges from 9 to 46 pts/50
Selection of 9 sites proposals
2 new sites and 1 new country
Allocation of 919 500 € for 16 700 expected LCI
Sites selection: how did it work?
Season 2019-20
Call for tender published on
DRIVE website
Deadline for sites applications
ISC scientific evaluation
SC strategic pre-selection
Deadlines for sites’ answers
SC final decision presented
to ISC on July 10

21. • Do you think the role of the ISC is appropriate?
• Do the members of the ISC provide diverse enough representation to provide
valuable input to the platform?
• Members of the ISC are reimbursed for travel but not paid for their time. Do you
think this is appropriate and sustainable to ensure the future of the platform?
• Do you think the process for site selection is appropriate?
• Is the process for reviewing scientific deliverables appropriate?
Survey questions – ISC

22. • Do you think the process for site selection is appropriate?
Baseline (season 17-18): 40% of the non DRIVE partners had questions/concerns
regarding the sites selection process
Survey results - ISC

23. 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.
Quality Control and Audit
Committee
Ann-Marie Kirby

24. To ensure strong high data quality
standards in line with industry
regulatory requirements, a Quality
Control and Audit Committee was set up
Evaluate the quality of the study
conduct, data reporting and the pooled
analysis
Deliver quality assessment report with
recommendations (appendix of the
annual report submitted to EMA)
QCAC role & mission
Season 2018-19
Ann-Marie Kirby
Sophie Gilles
Claire Pope

25. • Step 1 – Quality of Study Conduct
• 10/12 sites responded to questionnaire
• Scores are indicative of the Quality
Management System at the sites
• No critical concerns
• Some improvement recommendations
will be made
• Step 2 – Evaluation of P95 processes
• The documents provided to QCAC by P95 were
in compliance with principles for Data
Management and reporting as described in
Guidelines for GPP (2016)
• No major concerns regarding the content of the
Data Quality Reports
• 82% records accepted for the analysis
First year evaluation
Summary
QCAC stopped after Step 2 evaluation  Step 3 will be evaluated next year

26. • Do you think the role of the Quality control and Audit Committee is
appropriate?
• Do the members of the QCAC provide diverse enough representation to
provide valuable input to the platform?
• Members of the QCAC are reimbursed for travel but not paid for their time. Do
you think this is appropriate and sustainable to ensure the future of the
platform?
• How useful are the outputs from the QCAC’s first year evaluation?
Survey questions – QCAC

27. • Do you think the role of the Quality control and Audit Committee is appropriate?
Baseline (season 17-18):40% of the collaborators/external stakeholders had
questions/concerns regarding the role of the QCAC
• How useful are the outputs from the QCAC’s first year evaluation?
No baseline
Survey results - QCAC

28. DRIVE: An influenza season
Video

29. • Is a public-private partnership necessary to build this kind of study platform?
• How can we establish more trust around Public-Private collaborations?
• Is the overall explanation you have so far received on the study platform
governance clear for you?
• How appropriate is this study governance to provide robust and trusted scientific
results?
• How appropriate is the list of stakeholders to answer the objectives of the study
platform in DRIVE?
Survey questions – study platform

30. • How appropriate is this study governance to provide robust and trusted scientific
results?
Baseline (season 17-18):40% of the collaborators/external stakeholders had
questions/concerns regarding the study governance
Survey results – study platform

31. 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.
Open data model
Kaatje Bollaerts

32. • DRIVE study platform is established to do pooled analysis of IVE studies
conducted by independent operating sites
• Robust brand IVE requires huge sample size which could not be reached only
through public call with 1 million € budget per season
Open access strategy: the WHY
Need to use secondary data through an open data portal to leverage data sharing
of public or EU funded projects for the benefit of public health

33. Sharing IVE estimates Sharing aggregated data
Open access strategy: the HOW
Core data sharing model: 3 possibilities
Sharing patient-level data
Easy (put excel file
on the website
Limited flexibility
(sub-analysis?)
No privacy
protection issues
No surprises
(control over
calculation IVE
estimates)
More flexibility
(different strata
possible depending on
the research question)
Maybe surprises
(Want to know who
will use your data and
why? Protocol
required? Protocol
approval committee?
Disclaimer?)
No privacy protection
issues
(when cell counts large
enough)
More complicated to
technically implement
depending on the
level of user control
that is required
(However, the DRIVE
study platform is
designed to make this
possible)
Maximum flexibility
(Statistician can
optimally check and
understand data)
Privacy protection
must be guaranteed
(Conduct privacy
impact assessment,
implement disclosure
control strategies)
Maybe surprises
(Want to know who
will use your data and
why? Protocol
required? Protocol
approval committee?
Disclaimer? )
Most complicated as it
might additionally
require disclosure
control
+ - + - + -

34. • It is what the DRIVE consortium and data partners want (no technical constraints – the
DRIVE study platform is ready for it!)
• We might even have different data access for different organisations (e.g. more
granular data for organisations contributing data – ‘quid quo pro’ data sharing)
• Not intending to say that DRIVE should not try to agree on a most suitable data sharing
model
• Define a minimal core data model needed to allow brand specific IVE meta-analysis and
feasibility of data sharing with study sites in DRIVE (charter)
• Set up a pilot open data sharing platform that provides DRIVE 2018-19 season
summary data
• Pending questions: Hosting of the platform – timelines for sharing?
Pick-and-Mix
Open access strategy: the WHO & WHEN
Next steps

35. • Does your organisation have the capacity to share data or carry out influenza
vaccine effectiveness studies?
• Are you or your organisation interested in joining DRIVE? Please note that
answering yes or maybe does not oblige you to join.
• What do you see as potential benefits of joining DRIVE?
• What do you see as the potential drawbacks of joining DRIVE?
• Does the new proposal for open data make you more likely to participate in
DRIVE than before this was an option? What are the potential barriers to open
data strategy?
• Is information about governance on the DRIVE website clear enough?
Survey questions – open data model

36. • Are you or your organisation interested in joining DRIVE?
Baseline (season 17-18): 70% collaborators/external stakeholders responded
possibly & yes
• Does the new proposal for open data make you more likely to participate in
DRIVE than before this was an option? What are the potential barriers to open
data strategy?
No baseline
Survey results – open data model

37. What’s next?
• Completion of the survey by DRIVE partners and ISC QCAC members
during Annual meeting (email with SurveyMonkey link)
• Analysis of the results and discussions on governance adaptations
when relevant with SC/ISC/QCAC
• Reporting to IMI and sharing on DRIVE website
Thank for your active participation!

38. 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.
Welcome as public
partner WP1 lead
Odile Launay
Christine Pereira
Alexandre Descamps

39. 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.
Coffee break

40. 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.
Backup

41. DRIVE collaborators (study sites) and external stakeholders (24)
ECDC Pasi Penttinen
Health Protection Surveillance Centre (HPSC) Jolita Mereckiene
NIJZ, NATIONAL INSTITUTE OF PUBLIC HEALTH Mateja Lamovšek
ARISTOTLE UNIVERSITY OF THESSALONIKI Georgia Gioula
Paul-Ehrlich-Institut Isabelle Bekeredjian-Ding
The National Institute of Public Health Alena Fialová
Helsinki University Hospital
Raija Auvinen
Ulrike Baum
Laboratoire National de Santé Joël Mossong
Bambino Gesù Childrens' hospital
Elisabetta Pandolfi
Sara Ciampini
CIRI-IT
Donatella Panatto
Stefano Mosca
Federico Grammatico
Vall d'Hebron University Hospital José Ángel Rodrigo Pendás
Cittadinanzattiva-Active Citizenship Network Mariano Votta
Hospital Universitario La Paz Alejandro Martín Quirós
Medical University of Vienna Katrin Wiedeschitz
ASL Roma 1, Lazio Regional Health Service Ursula Kirchmayer
European Medicines Agency Manuela Mura
IMI2 JU Tek-Ang LIM
INSERM
Odile Launay
Christine Pereira
Alexandre Descamps

42. Timing
LP 1’ LP 1’
LP 1’ LP 2’
LP 2’ LP 1’
LP 3’
interviewees10’
LP1 8’
LP 2’
LP 2’
SN 2’
LP 2’
MvdS 1’ MvdS 2’
MvdS 2’ MvdS 2’
14h45
15h00
15h24

43. Timing
LP 2’ LM 2’
LM 5’ LM 10’
AMK 1’
ANK 1’ ANK 5’
ANK 10’ SN 3’
SN 5’ SN 10’
KB 1’
KB 2’ KB 2’
SN 5’ SN 8’
LP 1’ LP 1’
15h50
16h07
16h25
16h45

44. https://klaxoon.com/fr/

45. DRIVE collaborators (study sites)
&
external stakeholders