How to organize a Clinical Theranostics Trial?

Transcription

1 How to organize a Clinical Theranostics Trial? International Course on THERANOSTICS AND MOLECULAR RADIOTHERAPY Julie Gaye IJB-CTSU October 4, 2017

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4 Research proposal Competent Authorities and/or Ethics Committees approval First Patient In Last Patient Out End of study Results publication Sponsor: Hospital Pharmaceutical company Biotech company National agency Academic institution Set-up phase Conduct phase Closure phase SPONSOR Participating sites: Hospitals Patients inclusion and management HOSPITAL

5 IMP Interventional Retrospective

6 Prospective Interventional Observational Clinical trial IMP/Device IMP/Device Retrospective

7 Research proposal Competent Authorities and/or Ethics Committees approval First Patient In Last Patient Out End of study Results publication Sponsor: Hospital Pharmaceutical company Biotech company National agency Academic institution Set-up phase Conduct phase Closure phase SPONSOR Participating sites: Hospitals Patients inclusion and management HOSPITAL

8 Synopsis Protocol

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10 Synopsis Protocol Sites selection

11 Feasibility questionnaire / Survey Realistical number of potential patients? Participation in any competing trials? Facilities? Research physician/nurses? Imaging Brand/model PET/CT? Brand/model dose calibrator? Routine QC procedure? EARL accreditation? Radiopharmaceutical product(s) Onsite production? GMP certification? Commercial supplier?...

12 Synopsis Protocol Sites selection Imaging

13 Standard Procedures Imaging Manual - SPIM Equipment QC Accreditation/Phatom program Data acquisition method Reconstruction Patients management (injection, positioning) Dosimetry method Data transfert Images QC STANDARDISATION and HARMONIZATION Imaging CoreLab

14 Synopsis Protocol Sites selection Imaging IMP supply chain

15 IMP supply chain Central production (e.g. commercial supplier) Manufacturer GMP compliance Shipments to the sites Local production (e.g. on site) Description of the manufacturing process QC and Validation Pre-clinical data Labelling Investigational Medical Product Dossier IMPD

16 Synopsis Protocol Sites selection Imaging IMP supply chain Budget

17 Budget Fix costs = Management Costs (sponsor level) Variable costs = per patient costs (site level) ASSESSMENT SCREENING Cycle 1 STUDY TREATMENT Cycle X EOS C 1D 1 C 1D 8 C 1D 15 C 1D 21 C XD 1 C XD 8 C XD 15 C XD 21 Study coordination Tracer Injection Pregnancy test (serum) Drug infusion one day one day one day one day one day one day one day one day clinic clinic clinic clinic clinic clinic clinic clinic Radio-pharmacist fees CT Scan FDG PET/CT SOC

18 Synopsis Protocol D R A F T ICF Sites selection Imaging IMP supply chain Budget

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20 Synopsis Protocol D R A F T ICF CRF Database Sites selection Imaging IMP supply chain Budget

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22 Synopsis Protocol D R A F T ICF Submission EC&CA CRF Database Sites selection Sites contracts Sites Initiation Visits Imaging IMP supply chain Budget

23 Research proposal Competent Authorities and/or Ethics Committees approval First Patient In Last Patient Out End of study Results publication Sponsor: Hospital Pharmaceutical company Biotech company National agency Academic institution Set-up phase Conduct phase Closure phase SPONSOR Participating sites: Hospitals Patients inclusion and management HOSPITAL

24 Patients accrual Data management Medical & Safety review Imaging quality Monitoring

25 Research proposal Competent Authorities and/or Ethics Committees approval First Patient In Last Patient Out End of study Results publication Sponsor: Hospital Pharmaceutical company Biotech company National agency Academic institution Set-up phase Conduct phase Closure phase SPONSOR Participating sites: Hospitals Patients inclusion and management HOSPITAL

26 L P O Data cleaning End of Study declaration Analysis Publications

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28 Main objectives Provide services and advice to the researchers Manage clinical trials from A to Z

29 Take home message Together, we are stronger

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