MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
90 High Holborn
The MRC, as trial Sponsor, has overall responsibility for site and investigator selection. FOCUS4 includes the use of novel therapies (either single agent or combinations of agents) in a widely dispersed collaborative group of sites. For each novel therapy arm, in collaboration with the company providing the novel agent(s), a safety assessment has been performed and will be updated when required.
The FOCUS4 Trial Management Group (TMG) has identified three categories of sites (Levels 1, 2 and 3) and each FOCUS4 Trial protocol will state the activities for each individual trial which may be undertaken at the different levels. Sites participating in the trial are required to complete a Site Evaluation form which is assessed by the FOCUS4 Site Evaluation Committee. Those invited to participate in the trial will be allocated into one of the following three levels:
All level 1 sites will be able to participate in patient registration; recruitment and administration of treatment for the FOCUS4-N trial; referral of patients to level 2 and 3 sites for randomisation to the other FOCUS4 trials; and follow-up for novel agents where sufficient preliminary data are available to confirm safety on a per patient basis.
A full list of eligibility criteria are provided here: Level 1 site eligibility critieria.
In addition to performing the level 1 site activities for its its own local population, these sites will also have additional responsibilities.
A full list of eligibility criteria are provided here: Level 2 site eligibility critieria.
These include ECMCs or those with equivalent experimental treatment experience. They will be able to perform all the responsibilities of the Level 1 and 2 sites as above. In addition, in collaboration with the early phase trials unit in the site, they will initiate and administer the high risk novel therapies deemed by safety review to require experimental treatment site support.
A full list of eligibility criteria are provided here: Level 3 site eligibility critieria.