| Main themes | Sub-themes |
---|---|---|
Recruitment and set-up phase | Recruitment processes | Recruitment target |
Recruitment strategy | ||
Ease of recruitment | ||
Recruitment period | ||
Protocol-related factors | • Eligibility criteria | |
• Standard NHS treatment and licensed treatment | ||
• Protocol breach | ||
• Randomisation and processes around randomisation | ||
• Patient perspective on randomisation | ||
Human factors | • Investigator bias | |
• Communication between sites and sponsor | ||
• Dedicated members of research teams recruiting patients | ||
Challenges | • Delays | |
• Limited resources | ||
• Site withdrawals | ||
• Patient withdrawals | ||
• Competing for PIs time | ||
• Building teams | ||
Running the MATE study | Variation | • Individual site setup and local NHS AMD treatment service delivery pattern |
• Variation in practice at sites in comparison with MATE study and between sites | ||
• Support to teams and level of engagement with sponsor | ||
• Documentation — GCP validity and recording of AEs | ||
• Individual site research experience and level of research activity | ||
• Challenges due to variation — protocol deviation and capacity | ||
Challenges | • Staff turnover — both PI and nursing | |
• Protocol-related deviations and data quality | ||
• Limited resources — staff and finances | ||
• Clinical trial planning — continuity of care |