Table 1 Influence of main cost drivers on the study budget
From: Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency
| Sections in study budget | Main cost drivers of study budget | ||||
|---|---|---|---|---|---|
| Recruitment period (FPI to LPI) | Study period (FPI to CSR) | No. of patients | No. of study visits | No. of sites | |
| Project design and set-up | ++ | ||||
| Regulatory and ethics review | + | ++ | |||
| Monitoring | + | + | + | + | +++ |
| Quality assurance | |||||
| Trial master file handling & administration | + | + | + | ||
| Safety | + | ||||
| Data management | + | + | |||
| Statistics, report and publication | |||||
| Project management | + | +++ | ++ | ||
| Patient and public involvement | + | ||||
| Intervention (medication/device) handling | + | + | + | + | |
| Site costs | +++ | + | + | ||
| External vendors/contractors/central review | |||||