MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
90 High Holborn
2nd Floor
London
WC1V 6LJ
Email. mrcctu.focus4@ucl.ac.uk
FOCUS4 COMMON TERMINOLOGY
A description of terms used commonly throughout the FOCUS4 Protocol
| TERM | MEANING |
| FOCUS4 | The whole FOCUS4 Trial Programme |
| Master Protocol | The FOCUS4 Master Protocol describes the procedures for patient identification, registration, biomarker testing and initial 16 weeks of standard therapy procedures. It also contains generic information relating to all trials in the FOCUS4 Trial Programme. |
| FOCUS4-A | The name for a specific trial (letter A onwards) |
| Trial Protocol | The protocol for a specific trial (letter A onwards) |
| Molecular cohort | The molecular sub-group determined from the biomarker tests performed on the tumour sample sent off at registration. The current molecular cohort classification is:
|
| Biomarker defined cohort | Same as molecular cohort |
| Stage I, II, III or IV | The interim analysis stages in the MAMS design. |
| Phase 2 or 3 | The phases of the trial: Phase 2 includes stages I and II Phase 3 includes stages III and IV |
| Step 1 or 2 | The patient information and consent steps for registration (Step 1) and randomisation (Step 2) |
| Period | Registration or trial period |
| Level | Refers to the categorisation of participating trial sites into levels 1, 2 or 3. Initial treatment for some molecular cohorts may be limited to higher level sites. |
FOCUS4