Academic clinical trials

365 views

Published on

From idea to publication : critical points

Published in: Health & Medicine, Business
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
365
On SlideShare
0
From Embeds
0
Number of Embeds
9
Actions
Shares
0
Downloads
0
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Academic clinical trials

  1. 1. 1Academic clinical trialsFrom idea to publication
  2. 2. 2The Objectives• Health improvement• Scientific knowledge• Academic Education• Mastery• Fertilisation• Public
  3. 3. 3SummaryProtocol developmentSafety and Quality of dataSMI April 2013Governing the logisticsChronology of the steps and critical points
  4. 4. Protocol development4
  5. 5. 5Protocol development1. The hypothesis2. Drafting of the project3. ApplicationFeasibility
  6. 6. 6Protocol 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. 7Protocol 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. 8Protocol development – The applicationRegulatory applications• Procedures based on : internal / European /nationalregulations• Competent authorities• Ethics committee• Insurance• Agreements• Application of the publication to clinicaltrial.gov
  9. 9. 9Protocol development
  10. 10. Quality of data10
  11. 11. 11Quality of data1. Process2. Data collection & analysis3. Quality Control & Quality Assurance4. Publication
  12. 12. QuestionnaireSamplingMedical examinationTreatment unitResultsExamsReportsMedical supervisionPut files in orderHe does EncodingTranscriptionIn the CRFMonitoringHe preparesNext appointmentInterviewCare unitMedico-technicthe next appointmentsFollow upPharmacyGive his ConsentPhase 1 UnitLaboratoryBiobankOther treatmentScreeningDatacollection&analysisQualitycontrolandQualityAssurance
  13. 13. 13Quality of data– Process• Simulation: critical points and corrective actions• Checklist (IT)• Chronogram: steps of the project management
  14. 14. 14Quality 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. 15Quality of data– Supervision• Medical• Managerial• Monitoring• Audit• DSMB
  16. 16. 16Quality of data– Publication• Mentoring / Reviewers• Publication policy• Notoriety• Valorisation
  17. 17. Organising the logistics1815
  18. 18. 19Governing the logistics – Value chainDesignWhoWhatWhenOperationsHowStepsSOPResultsPublicationAbstractOral presentationPosterSupport: Management, Finance, Com, Equipment
  19. 19. 20Governing the logistics1. Value Chain2. Management3. Finance4. Communication5. Equipment
  20. 20. 21Governing the logistics – ManagementSeveral targetsProfessional: Ethics / CareersSkills: Scientist, Physician and..Human ManagementQuality spirit: Rigour / Example / CultureContinuity: Quantity / CompetitiveNetwork: Small / Economies of scaleEvaluations: Tips / Lessons / Good SOPs / Continuum
  21. 21. 22Governing the logistics– Finance• Structural and conjectural resources• Pharmaceutical Industry: Supporter / Provider• Records: Margins• Accounting support: Invoices / Descriptive stat / Conventions• Networking and mobility
  22. 22. 23Governing the logistics– CommunicationMeetings, mails, staffs, news letters will allow to• Federation• Contacts: Network / Partners / GP / Internal & External• Regular brainstorming• Evaluations of SOP and corrective actionsIT
  23. 23. 24Governing the logistics – EquipmentMedical 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
  24. 24. Critical points25
  25. 25. 26Critical points1. Innovative process2. Good questions.
  26. 26. 27Critical points– Innovative processIdea -> strategy -> actionActors: Identifying / Assessing / Launching / Convincing /Focus on opportunities / Pro active / Cope with the risksLeader: look for consensus, not groupthink / welcome newideas, new behaviours / stretch & no stress / indicators onlyfor motivationCEO: Facilitate / Approved / Fertilization
  27. 27. 28Critical points– Role of CEOIdea -> strategy -> actionStrategy: Mining or Hunting / Push or PullAtmosphere: combine discipline and efficiency / reactivity andagility / Values / AutonomyStructure: big gives more legitimacy / research capacity / butdifficulties to change
  28. 28. 29Critical points– IntegrationOpen innovation: Collaboration, Clusters, Alumni, ProfessionalassociationsAcademic freedom: what to share and with whom, negotiateex ante and share ex post / intellectual property rightsNetworking and mobility: notoriety attracts partnersHave something to be courted
  29. 29. 30Critical points1. Innovative process2. Good questions23
  30. 30. 31Critical points– ImprovementWhat are the steps which deserve special attention ?Which fertilizer would be useful ?Judge each organization separatelyUP TO YOU
  31. 31. 32Critical points– InterventionReading GRID of the steps potentially critical pointsReview 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 actionSupport should be provided
  32. 32. 33Critical points– The good questionsStrengths Weakness To doHealth improvement: New findings / New treatmentsProfessional: Skills / NotorietyFinancial: Marginal / IndirectAcademic Education: Mentoring / TeachingTraining: Long term process to the master workFertilisation: nourishing the ground of researchProfessional: Deontology / Ethic / Carrier / AchievementQuality: Rigour / SOPQuantity: Recruitment & retention / Data entry / TimetableAtmospheres: HR / Skills / Training / Motivation / Self accomplishment / MembershipContinuity: Sustainability of the organisation / StrengthsWhat do I need to improve ?Difficulties: under control / need to reach objectives
  33. 33. 34Critical 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 mindTake a break questioning him or herself, and be versatile
  34. 34. 35From idea to publicationConclusionResearcherPhysicianScientistManager

×