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Table 5 Key themes and individual themes relating to the recruitment and set-up phase and the running of the MATE study identified from semi-structured interviews with key members of the study team

From: The MATE trial: a multicentre, mixed-methodology, pilot, randomised controlled trial in neovascular age-related macular degeneration

 

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

  1. PI principal investigator, AMD age-related macular degeneration, GCP good clinical practice, AEs adverse events