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Similar to Pam Kearns: How can I do my Clinical Trial?
Pam Kearns: How can I do my Clinical Trial?
- 1. How can Ido 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: clinicaltrial algorithm Http://www.mhra.gov.uk
- 4. The route toopening 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 TOPTIPS • 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 ontrial 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 costsof 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 Sponsoragreement 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
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- 10. FULL REGULATORY APPROVAL OPEN TRIAL Contracts AdditionalTrial documents Pharmacy manual databases CRFs Master and Site files
- 11. FULL REGULATORY APPROVAL OPEN TRIAL Contracts AdditionalTrial documents Trial Launch meeting Site initiation
- 12. Trial Management froma 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.
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