how to organize a clinical theranostics trial? · clinical trial . set -up phase sponsor : x...
TRANSCRIPT
How to organize a
Clinical Theranostics Trial?
International Course on
THERANOSTICS AND MOLECULAR RADIOTHERAPY
Julie Gaye IJB-CTSU
October 4, 2017
Set-up phase
Sponsor: Hospital Pharmaceutical company Biotech company National agency Academic institution
Conduct phase Closure phase
Last Patient OutEnd of study
Competent Authorities and/or Ethics
Committees approvalFirst Patient In
Research proposal
Results publication
SPONSOR
Patients inclusion and management
Participating sites: Hospitals
HOSPITAL
Interventional
Retrospective
IMP
Prospective
Interventional
IMP/Device
IMP/Device
Observational
Retrospective
Clinical trial
Set-up phase
Sponsor: Hospital Pharmaceutical company Biotech company National agency Academic institution
Conduct phase Closure phase
Last Patient OutEnd of study
Competent Authorities and/or Ethics
Committees approvalFirst Patient In
Research proposal
Results publication
SPONSOR
Patients inclusion and management
Participating sites: Hospitals
HOSPITAL
Protocol Synopsis
Protocol Synopsis
Sites selection
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?
...
Protocol Synopsis
Sites selection
Imaging
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
Protocol Synopsis
Sites selection
Imaging
IMP supply chain
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
…
Protocol
Budget
Synopsis
Sites selection
Imaging
IMP supply chain
Budget • Fix costs = Management Costs (sponsor level)
• Variable costs = per patient costs (site level)
…
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 €0 €0 €0 €0 €0 €0 €0 €0 €0
Tracer Injection €0 €0 €0 €0 €0
Pregnancy test (serum) €0 €0
€0 €0 €0 €0 €0 €0 €0 €0
one day
clinic
one day
clinic
one day
clinic
one day
clinic
one day
clinic
one day
clinic
one day
clinic
one day
clinic
Radio-pharmacist fees €0 €0 €0 €0 €0 €0 €0 €0
FDG PET/CT
€0 €0 €0 €0 €0 €0 €0 €0 €0 0 €
SCREENING
Drug infusion
CT Scan SOC
€0
€0
€0
€0
€0
Cycle XASSESSMENT
STUDY TREATMENT
EOSCycle 1
Protocol
Budget
Synopsis
D
R
A
F
T
ICF
Sites selection
Imaging
IMP supply chain
Protocol
CRF
Budget
Synopsis
Database
D
R
A
F
T
ICF
Sites selection
Imaging
IMP supply chain
Protocol
CRF
Submission EC&CA
Budget
Sites contracts
Synopsis
Database
D
R
A
F
T
Sites Initiation Visits
ICF
Sites selection
Imaging
IMP supply chain
Set-up phase
Sponsor: Hospital Pharmaceutical company Biotech company National agency Academic institution
Conduct phase Closure phase
Last Patient OutEnd of study
Competent Authorities and/or Ethics
Committees approvalFirst Patient In
Research proposal
Results publication
SPONSOR
Patients inclusion and management
Participating sites: Hospitals
HOSPITAL
Medical & Safety review
Data management
Patients accrual
Imaging quality
Monitoring
Set-up phase
Sponsor: Hospital Pharmaceutical company Biotech company National agency Academic institution
Conduct phase Closure phase
Last Patient OutEnd of study
Competent Authorities and/or Ethics
Committees approvalFirst Patient In
Research proposal
Results publication
SPONSOR
Patients inclusion and management
Participating sites: Hospitals
HOSPITAL
Data cleaning
End of Study declaration
Publications
L
P
O
Analysis
Main objectives • Provide services and advice to the researchers • Manage clinical trials from A to Z
Take home message
“Together, we are stronger”
