WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire...
Transcript of WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire...
![Page 1: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/1.jpg)
WORKING GROUP 3&5:
PUBLIC-PRIVATE PARTNERSHIP
Susan Tansey / Pirkko Lepola
Chair / Co-Chair WG 3&5
07June2018 Enpr-EMA Annual WS / WG3+5 1
![Page 2: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/2.jpg)
Enpr-EMA WG 3&5
Role:
• Facilitate communication between industry and
networks
• Gather examples of good practice from Networks
and industry working with Enpr-EMA networks
• Develop proposals to disseminate examples of good
practice to Enpr-EMA networks and industry
07June2018 Enpr-EMA Annual WS / WG3+5 2
![Page 3: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/3.jpg)
Enpr-EMA WG 3&5
07June2018 Enpr-EMA Annual WS / WG3+5
WG 3&5 Steering Committtee members:
Martine Dehlinger-Kremer
Susan Tansey ( Acting Chair)
Pirkko Lepola (Co-Chair)
Jenny Preston
Colin Hayward
Mark Sorrentino
Heidrun Hildebrand
Andrea Wassmuth
(Mark Turner)
Other members WG 3&5:
Pamela Dicks
Stefanie Breitenstein
Cristina Serén Trasorras
3
![Page 4: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/4.jpg)
Task 1.;
Network & Industry survey; 12/2013 - 02/2014
Deliverable 1: Publication: ‘Pharmaceutical Industry and
Pediatric Clinical Trials networks in Europe- how do they
communicate?’ , Applied Clinical Trials, Jan 08 2016.
Pirkko Lepola, Susan Tansey, Pamela Dicks, Jennifer Preston, Martine
Dehlinger-Kremer
Task 2.;
Network consultation recommendation; 12/2015 -> 04/2017
Deliverable 2: Consultation recommendation document +
diagram to be placed on Enpr-EMA website for the sponsors and
CROs;
• Distributed for consultations; 06/2016 – 08/2016
• Final draft 04/2017; version 10 -> FINAL AT THIS POINT
.
Enpr-EMA WG 3&5
07June2018 Enpr-EMA Annual WS / WG3+5 4
![Page 5: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/5.jpg)
Background for Task 2
■ Knowledge from the Task 1 – the Industry perspective & expectations to the networks (more detailed services)
■ Need to have more detailed search engine for Enpr-EMA – to add more detailed network service information in addition to the existing membership criteria in the Enpr-EMA database of member networks
■ Currently, the list of services (Network ConsultationRecommendation, v. 10.0) and the Enpr-EMA Database of member networks are not connected
■ The list of services (Network Consultation Recommendation, v. 10.0) has not yet been published on Enpr-EMA website
07June2018 Enpr-EMA Annual WS / WG3+5 5
![Page 6: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/6.jpg)
Version 10.0
07June2018 Enpr-EMA Annual WS / WG3+5 6
NOT YET PUBLISHED ON Enpr-EMA WEBSITE
![Page 7: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/7.jpg)
Version 10.0
07June2018 Enpr-EMA Annual WS / WG3+5 7
![Page 8: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/8.jpg)
07June2018 Enpr-EMA Annual WS / WG3+5
Enpr-EMA WG 3&5
8
![Page 9: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/9.jpg)
Version 10.0 – Consultation diagram
16/05/2017 Enpr-EMA Annual WS / WG3+5 9
![Page 10: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/10.jpg)
Enpr-EMA WG 3&5
Task 3.; – original plan (2017):
■ Pilot period - test phase - for using these Enpr-EMA
consultation services FOR FREE
Selection of interested networks (e.g. 5-6) ->
SURVEY
Selection of interested companies for pilot phase (e.g. 5-6)
■ Max. 1-2 cases / company to be served
■ After pilot phase; survey to these companies; evaluation and
analysis of these services – did they bring any value?-> PoC
■ Publication of the survey results; collected experience
■ Decision of the continuation; with OR without the fees
07June2018 Enpr-EMA Annual WS / WG3+5 10
![Page 11: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/11.jpg)
Enpr-EMA WG 3&5
Selection of interested networks (e.g. 5-6) ?
Questionnaire prepared and sent out to Enpr-EMA Category 1
(N=21) networks 3rd April 2018
Responses requested by 4th May 2018
Extended deadline to 14th May 2018
7 responses (N=8–1 excluded) received and could be
analysed
Resulted ----> very low number of responses
Invitation letter to industry prepared (ready to use – if it will
be used…)
07June2018 Enpr-EMA Annual WS / WG3+5 11
similar activities was known to be planned by C4C EU-project –
details were not known by the beginning of the year 2018!
![Page 12: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/12.jpg)
07June2018 Enpr-EMA Annual WS / WG3+5 12
All Survey Categories were
derived from the following
existing data elements:a) Network consultation
recommendation (2015-2017) –
Task 2.
b) Expertise required by the
Industry; Publication (2013-
2014) – Task 1.
a) 4 categories:
1. Scoping – 22 elements
2. Doability – 9 elements
3. Feasibility – 13 elements
4. Reporting – 3 elements
b) 4 categories:
1. Scientific Advice,
Communication, Training
and Recourses,
2. Legal / Administrative Advice
3. Feasibility Assessment
4. Patient Involvement;
- Total - 29 elements
3 Questions
![Page 13: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/13.jpg)
Analysis & Results of the network Questionnaire responses
07June2018 Enpr-EMA Annual WS / WG3+5 13
![Page 14: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/14.jpg)
07June2018 Enpr-EMA Annual WS / WG3+5 14
N=7
![Page 15: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/15.jpg)
07June2018 Enpr-EMA Annual WS / WG3+5 15
![Page 16: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/16.jpg)
07June2018 Enpr-EMA Annual WS / WG3+5 16
![Page 17: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/17.jpg)
Results - Conclusion
07June2018 Enpr-EMA Annual WS / WG3+5 17
1,4
0,22
0,15
0
1,01
1
0,5
0,5
0 0,2 0,4 0,6 0,8 1 1,2 1,4 1,6
1. CONSULTATION: SCOPING
2. CONSULTATION: DOABILITY
3. CONSULTATION: FEASIBILITY
4. CONSULTATION: REPORTING & SAFETY FOLLOW-UP
SCIENTIFIC ADVICE, COMMUNICATION, TRAINING AND
RECOURSES
FEASIBILITY ASSESSMENT (LOCAL / NATIONAL)
PATIENT INVOLVEMENT / INVESTIGATORS
INVOLVEMENT
LEGAL ADVICE / ADMINISTRATION & MANAGEMENT
Result of 8 main categories of services without
service fee – sum average of averages
![Page 18: WORKING GROUP 3&5: PUBLIC-PRIVATE PARTNERSHIP · Task 3.; –original plan ... Questionnaire prepared and sent out to Enpr-EMA Category 1 (N=21) networks 3rd April 2018 Responses](https://reader036.fdocuments.in/reader036/viewer/2022070917/5fb7c1cd14e738420c7d8252/html5/thumbnails/18.jpg)
Continuation ?
■ Result does not encourage to organize pilot period –test phase
for networks for free (too few networks operate for free)
■ Use of the data (low reliability) need to be dicussed with all
stakeholders – usable?
■ Use of the consultation recommendation? – not yet connected
to Enpr-EMA networks – needs to be discussed
■ Further actions under decision of Enpr-EMA
07June2018 Enpr-EMA Annual WS / WG3+5 18