From idea to publication : critical points

1. 1
Academic clinical trials
From idea to publication

2. 2
The Objectives
• Health improvement
• Scientific knowledge
• Academic Education
• Mastery
• Fertilisation
• Public

3. 3
Summary
Protocol development
Safety and Quality of data
SMI April 2013
Governing the logistics
Chronology of the steps and critical points

4. Protocol development
4

5. 5
Protocol development
1. The hypothesis
2. Drafting of the project
3. Application
Feasibility

6. 6
Protocol development – The project
• Definition of the objective(s)
• Key indicators
• Biological markers
• Inclusion / exclusion criteria: Bias / Power
• Epidemiologic model: Statistician / Literature / Simulation
• Under ethical norms

7. 7
Protocol development – The drafting
• First drafts: submit to peers / statisticians
• Follow-up: retaining patients / bottle necks
• Final draft
• Case report form (CRF)
• Informed patient consent

8. 8
Protocol development – The application
Regulatory applications
• Procedures based on : internal / European /national
regulations
• Competent authorities
• Ethics committee
• Insurance
• Agreements
• Application of the publication to clinicaltrial.gov

9. 9
Protocol development

10. Quality of data
10

11. 11
Quality of data
1. Process
2. Data collection & analysis
3. Quality Control & Quality Assurance
4. Publication

12. Questionnaire
Sampling
Medical examination
Treatment unit
Results
Exams
Reports
Medical supervision
Put files in order
He does Encoding
Transcription
In the CRF
Monitoring
He prepares
Next appointment
Interview
Care unit
Medico-technic
the next appointments
Follow up
Pharmacy
Give his Consent
Phase 1 Unit
Laboratory
Biobank
Other treatment
Screening
Datacollection&analysis
QualitycontrolandQualityAssurance

13. 13
Quality of data– Process
• Simulation: critical points and corrective actions
• Checklist (IT)
• Chronogram: steps of the project management

14. 14
Quality of data– DBC / DAC / DSMB
• CRF / Indicators
• Database: Encoding / Real time / Queries
• AE / Safety / DSMB
• Descriptive stat
• Biostatistics
• Regulatory: Amendment / Reports
• Closing / Archives

15. 15
Quality of data– Supervision
• Medical
• Managerial
• Monitoring
• Audit
• DSMB

16. 16
Quality of data– Publication
• Mentoring / Reviewers
• Publication policy
• Notoriety
• Valorisation

18. Organising the logistics
18
15

19. 19
Governing the logistics – Value chain
Design
Who
What
When
Operations
How
Steps
SOP
Results
Publication
Abstract
Oral presentation
Poster
Support: Management, Finance, Com, Equipment

20. 20
Governing the logistics
1. Value Chain
2. Management
3. Finance
4. Communication
5. Equipment

21. 21
Governing the logistics – Management
Several targets
Professional: Ethics / Careers
Skills: Scientist, Physician and..
Human Management
Quality spirit: Rigour / Example / Culture
Continuity: Quantity / Competitive
Network: Small / Economies of scale
Evaluations: Tips / Lessons / Good SOPs / Continuum

22. 22
Governing the logistics– Finance
• Structural and conjectural resources
• Pharmaceutical Industry: Supporter / Provider
• Records: Margins
• Accounting support: Invoices / Descriptive stat / Conventions
• Networking and mobility

23. 23
Governing the logistics– Communication
Meetings, mails, staffs, news letters will allow to
• Federation
• Contacts: Network / Partners / GP / Internal & External
• Regular brainstorming
• Evaluations of SOP and corrective actions
IT

24. 24
Governing the logistics – Equipment
Medical and non medical equipment
• Material purchases: Best product / Good value
• Maintenance: Depreciation / Insurance / Calibration
• Workspace: Access / Cleaning / Security
• Centralisation: Economies of scale
• IT: Check lists / SOP / Integrated DB / Export / Archives
• Bio bank

25. Critical points
25

26. 26
Critical points
1. Innovative process
2. Good questions
.

27. 27
Critical points– Innovative process
Idea -> strategy -> action
Actors: Identifying / Assessing / Launching / Convincing /
Focus on opportunities / Pro active / Cope with the risks
Leader: look for consensus, not groupthink / welcome new
ideas, new behaviours / stretch & no stress / indicators only
for motivation
CEO: Facilitate / Approved / Fertilization

28. 28
Critical points– Role of CEO
Idea -> strategy -> action
Strategy: Mining or Hunting / Push or Pull
Atmosphere: combine discipline and efficiency / reactivity and
agility / Values / Autonomy
Structure: big gives more legitimacy / research capacity / but
difficulties to change

29. 29
Critical points– Integration
Open innovation: Collaboration, Clusters, Alumni, Professional
associations
Academic freedom: what to share and with whom, negotiate
ex ante and share ex post / intellectual property rights
Networking and mobility: notoriety attracts partners
Have something to be courted

30. 30
Critical points
1. Innovative process
2. Good questions
23

31. 31
Critical points– Improvement
What are the steps which deserve special attention ?
Which fertilizer would be useful ?
Judge each organization separately
UP TO YOU

32. 32
Critical points– Intervention
Reading GRID of the steps potentially critical points
Review all stages, actors, goals
• Stakeholders identify critical points
• Head of unit define the main objective
• Options to reach the objective
• How to put the options in action
Support should be provided

33. 33
Critical points– The good questions
Strengths Weakness To do
Health improvement: New findings / New treatments
Professional: Skills / Notoriety
Financial: Marginal / Indirect
Academic Education: Mentoring / Teaching
Training: Long term process to the master work
Fertilisation: nourishing the ground of research
Professional: Deontology / Ethic / Carrier / Achievement
Quality: Rigour / SOP
Quantity: Recruitment & retention / Data entry / Timetable
Atmospheres: HR / Skills / Training / Motivation / Self accomplishment / Membership
Continuity: Sustainability of the organisation / Strengths
What do I need to improve ?
Difficulties: under control / need to reach objectives

34. 34
Critical points– Results
• Partnership: Time / Analysis / Focus on goals / Trusted
• Helicopter view: Important things / Save time
• Reframing: Change for more useful behaviours
• Making the best decision: Strengths / Weaknesses
• Resources inventory: New
• Innovation mind
Take a break questioning him or herself, and be versatile

35. 35
From idea to publication
Conclusion
Researcher
Physician
Scientist
Manager