1. Rational pharmacotherapy (GGG)
Dr. Harald Moonen
Paul Janssen FutureLab 21 Sept 2017

2. Agenda The Rational Pharmacotherapy program
Rational Pharmacotherapy (GGG)
Agenda
The Rational Pharmacotherapy program
How to submit an application
Timeline

3. Rational pharmacotherapy
Rational Pharmacotherapy (GGG)
Rational pharmacotherapy
Stimulate implementation
Implementation
Appropriate drug and dose prescibed?
Drug appropriately used?
Drug prescribed where needed?
Other indications?
Research
Infrastructure for intervention studies
Patient registries (outcome)
Infrastructure

4. Rational Pharmacotherapy (GGG)
Preconditions
Focus on improving quality of care and health care efficiency
Licensed medicinal products
Lack of commercial stimulus
Concrete results
Stimulating transition of results into daily practice

5. What should the program yield?
Rational Pharmacotherapy (GGG)
What should the program yield?
Improvement of quality of (pharmacotherapeutic) care
Cost savings
Change in daily practice!

6. Goal of the program = goal of the call
Rational Pharmacotherapy (GGG)
Goal of the program = goal of the call
To make the use of available medicines safer, more effective and more efficient
(care concerning) the use of medicines in daily practice is pivotal
 Relevant question/problem from practice

7. Rational Pharmacotherapy (GGG)
Who can apply?
The project leader must be employed by a Dutch organisation.
Commercial parties cannot be the main applicant, but are encouraged to be co-applicant and to co-finance the project.

8. General criteria Quality Relevance Rational Pharmacotherapy (GGG)
Problem definition and objective(s)
Strategy (design / outcome parameters / economic evaluation)
Feasibility of the study (realistic planning / inclusion)
Project group (multidisciplinary / expertise / experience)
Relevance
Added value of the study
Patient participation
Data management
Diversity

9. Program specific relevance criterium
Rational Pharmacotherapy (GGG)
Program specific relevance criterium
Relevance for clinical practice
1. Concrete revenues: what does it yield?
quantify if possible
2. Implementation of the results: should be guaranteed
transition into practice
broad support

10. Examples of concrete revenues
Rational Pharmacotherapy (GGG)
Examples of concrete revenues
Less doctor’s visits due to more effective treatment
Patients can work longer or return to work sooner
Less sick leave from school among young people due to better disease control
Cost savings due to more efficient prescribing of medicines
Less need for homecare due to more effective treatment
Improved quality of care for pregnant women using medicines due to knowledge from the ADE register

11. Transition into practice / broad support
Rational Pharmacotherapy (GGG)
Transition into practice / broad support
involvement of patient and practice in design and execution of project
patient and end user in project team
warrants for transition
route to guidelines, decision making, financing
broad support for use of results
Participation of multiple centers/groups

12. Convince the reviewers!
Rational Pharmacotherapy (GGG)
Convince the reviewers!
Extent of the problem in clinical practice
prevalence/incidence
effect size healthcare profit
budget impact
Feasibility
inclusion (availability of centers and patients)
expertise (incl HTA, patient participation)
preparation of medication (e.g. placebo)

13. Procedure: application submission
Rational Pharmacotherapy (GGG)
Procedure: application submission
Submission of application consists of:
Mandatory fields in Projectnet
Completed application form → upload as pdf attachment in Projectnet
Applications in English via ProjectNet
Detailed budget using the right budget format
Min 5% of budget to be reserved for implementation
Applications must meet ZonMw grant terms & conditions
After online submission: signed declaration of submission approval by main applicant + administrative responsible of your institute

14. Projectnet submission
Rational Pharmacotherapy (GGG)
Projectnet submission
1. Mandatory fields in Projectnet
Areas of interest (please tick 1 box per list) - Population (e.g. elderly, children, population wide etc.) - Setting (e.g. transmural, primary care, mental health care etc.)
Project members (max 10)
Summary (max characters)
will be used to find and approach reviewers
Key words (max 5)
among which the central specialism (e.g. geriatrics, psychiatry, internal medicine, general practicioner etc.)
Budget in detail (in Excel format) also: co-financing + amount + status

15. Projectnet submission
Rational Pharmacotherapy (GGG)
Projectnet submission
2. Application form (download from website)
General conditions
All text boxes need to be filled in (except literature references, this is optional).
No limitation to number of characters and/or words per text box, but total size max 8 pages A4.
It is possible to insert figures/tables into the text boxes.
Lettertype Arial (10 point size).
Basic application details (title page)
Name main applicant + title
Summary (same as in Projectnet)

16. Projectnet submission
Rational Pharmacotherapy (GGG)
Projectnet submission
2. Application form
Research proposal (max 8 A4 pages)
Problem definition and objective(s)
Strategy
Feasibility of the project
Relevance for clinical practice
Concrete revenues
Implementation of the results: feasibility and strategy
Patient participation
Expertise, prior activities, publications and products
Literature references

17. Rational Pharmacotherapy (GGG)
fill in text boxes (max 8 A4)
Convert to pdf (and check!)
upload as attachment in Projectnet

18. Projectnet submission
Rational Pharmacotherapy (GGG)
Projectnet submission
Other mandatory files to upload
Budget form (Excel form) ( see ‘Downloads budget English’)
Nomination letter Paul Janssen FutureLab
Literature review (‘state of the art’ overview on publications and trials)
Estimation of concrete revenues (Excel format)

19. Estimation of concrete revenues
Rational Pharmacotherapy (GGG)
Estimation of concrete revenues

20. Projectnet submission: checklist
Rational Pharmacotherapy (GGG)
Projectnet submission: checklist
Please use these numbers & titles in the file names of the appendices

21. Projectnet submission
Rational Pharmacotherapy (GGG)
Projectnet submission
Read the call text
+ appendices thoroughly !

22. Timeline Rational Pharmacotherapy (GGG) Nomination letter
13 October 2017
Deadline submission Projectnet
1 November 2017, h
Receipt of referee reports
Week 48 (27 Nov - 1 Dec 2017)
Deadline rebuttal
2 weeks after receipt referee reports
Grant decision
January 2018
Ultimate start date of project
July 2018
If granted, additionally you will be asked to submit a datamanagement plan (

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Rational Pharmacotherapy (GGG)
More information:
GGG team:
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