1. How can I do my clinical trial?

2. 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?

3. Useful guide: clinical trial algorithm
Http://www.mhra.gov.uk

4. 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

5. RESEARCH IDEA
TRIAL DESIGN
TOP TIPS
• Take advice from experienced trialists
• Statisticians do more than calculate the
sample size
• Approach a Clinical Trials Unit at this stage

6. TRIAL DESIGN
Decide on trial
management
structure
Decide on Sponsor
Identify funding
streams
TRIAL PROTOCOL
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

7. 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/PublicationsPolicyA
ndGuidance/DH_4125280

8. FULL REGULATORY
APPROVAL
TRIAL PROTOCOL
Sponsor agreement
All these steps take
time and are best
undertaken in
collaboration with an
experienced trial
management team
Trial Insurance
CTA from MHRA
Ethics Committee
approval
NHS permission

9. FULL REGULATORY
APPROVAL
OPEN TRIAL
Contracts
Pharma
contracts
Delegated
responsibilities
Site
agreements
others

10. FULL REGULATORY
APPROVAL
OPEN TRIAL
Contracts
Additional Trial
documents
Pharmacy
manual
databases
CRFs
Master and
Site files

11. FULL REGULATORY
APPROVAL
OPEN TRIAL
Contracts
Additional Trial
documents
Trial Launch meeting
Site initiation

12. 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.

13. Useful resources

14. http://www.ct-toolkit.ac.uk/

15. http://www.ct-toolkit.ac.uk/

16. http://www.birmingham.ac.uk/research/activity/mds/centres/bcct/index.aspx