pam kearns: how can i do my clinical trial?
TRANSCRIPT
How can I do my clinical trial?
Focusing on CTIMPs
• Clinical Trial of an Investigational Medicinal Product– a clinical trial that is within the scope of the UK
Medicines for Human Use (Clinical Trials) Regulations 2004.
How do you know if my trial is a CTIMP?
The route to opening a clinical trial
RESEARCH IDEA TRIAL DESIGN
TRIAL DESIGN TRIAL PROTOCOL
TRIAL PROTOCOL FULL REGULATORY APPROVAL
FULL REGULATORY APPROVAL OPEN TRIAL
TOP TIPS• Take advice from experienced trialists
• Statisticians do more than calculate the sample size
• Approach a Clinical Trials Unit at this stage
RESEARCH IDEA TRIAL DESIGN
TRIAL DESIGN TRIAL PROTOCOL
Identify funding streams
Grant Application tips
• A good application cannot be written in a rush
• Costing a clinical trial properly is complicated!
• Need to start process around 6 weeks before submission deadline– Remember PINK form– Need time for Finance to approve
the costings
Decide on Sponsor
Decide on trial management
structure
Calculating the costs of the trial
Costs• Research costs
– Data collection– Analysis– Other activities needed to
answer the question – Staff costs (direct and
indirect)
NHS• Support costs
– Additional patient related costs that would end when the research ended• Patient costs• Extra-inpatient days• Additional nursing costs
– Treatment costs• Patient treatment costs
which would continue after the research project ended
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4125280
TRIAL PROTOCOL FULL REGULATORY APPROVAL
CTA from MHRA
Trial Insurance
Sponsor agreement
Ethics Committee approval
NHS permission
All these steps take time and are best undertaken in collaboration with an experienced trial management team
FULL REGULATORY APPROVAL OPEN TRIAL
Contracts
Site agreements
othersDelegated responsibilities
Pharma contracts
FULL REGULATORY APPROVAL OPEN TRIAL
Contracts
Additional Trial documents
CRFs
Master and Site filesdatabases
Pharmacy manual
FULL REGULATORY APPROVAL OPEN TRIAL
Contracts
Additional Trial documents
Site initiation
Trial Launch meeting
Trial Management from a Chief Investigator’s perspective
• Work closely with the Trial Management Team
• Be responsible for the ongoing safety evaluation of the study
• Provide clinical advice to participating sites when requested
• Clinically assess the seriousness and expectedness of SAEs
• Assist in preparation of document amendments
• Help prepare multiple reports:
– ethics annual progress report, funder’s progress report, Clinical Study Group report, DMC reports, and the final reports to the MHRA and NRES
• Analyse data performed on the study data and to prepare manuscripts for publication.
Useful resources
http://www.ct-toolkit.ac.uk/
http://www.ct-toolkit.ac.uk/
http://www.birmingham.ac.uk/research/activity/mds/centres/bcct/index.aspx