Clinical trial budgeting approaches in Switzerland—a meta-research study

Table 2 Costs items pre-specified in budget planning tools

	Swiss Budget tools								International Budget Tool
Tools	CTU1	CTU2	CTU3	CTU4	CTU5	CTU6	CTU7	SNSF	Belgian KCE tool [9, 10]
Infrastructure and material	Yes	Yes	Yes	No	Yes	No	Yes	Yes	Yes
Laboratory and Diagnostics
Analysis	Yes	Yes	Yes	No	Yes	No	Yes	Yes	Yes
Shipment/sample transport	Yes	Yes	Yes	No	Yes	No	Yes	No	Yes
Sample storage	Yes	Yes	No	No	Yes	No	Yes	Yes	Yes
Imaging	Yes	Yes	Yes	No	Yes	No	No	Yes	Yes
Intervention
Intervention cost	Yes	No	Yes	No	No	No	No	Yes	Yes
Control/placebo cost	Yes	No	Yes	No	No	No	No	Yes	Yes
IMPs/medical devices storage	Yes	No	Yes	No	Yes	No	Yes	No	Yes
Regulatory and documentation
Submission process	Yes	Yes	Yes	No	Yes	Yes	Yes	Yes	Yes
Regulatory amendments	No	Yes	Yes	No	Yes	Yes	Yes	No	No
Site costs
Set up of sites	Yes	No	Yes	No	Yes	No	Yes	No	Yes
Documentation at study site	Yes	Yes	Yes	No	Yes	No	Yes	No	Yes
Insurance	Yes	No	Yes	No	No	No	Yes	No	Yes
Recruitment and retention
Screening	Yes	Yes	Yes	No	Yes	No	No	No	Yes
Dropouts	Yes	Yes	No	No	No	No	No	No	No
Patient compensation	Yes	No	Yes	No	Yes	No	Yes	No	Yes
Safety and quality assurance
SAEs/AEs/SUSAR	Yes	Yes	Yes	No	Yes	No	Yes	No	No
Audits and inspections	Yes	No	Yes	No	No	Yes	No	No	Yes
Data Management
Set-up, validation, maintenance of CRF	Yes	Yes	Yes	No	Yes	Yes	Yes	No	Yes
Data cleaning	No	Yes	Yes	No	No	Yes	No	No	Yes
Data sharing/data access committee	Yes	No	No	No	No	No	Yes	Yes	No
Monitoring
Central monitoring	Yes	Yes	No	No	No	Yes	Yes	Yes	Yes
Site visits	No	Yes	Yes	No	No	Yes	Yes	No	Yes
Statistics
Statistician	Yes	Yes	No	No	No	Yes	Yes	No	Yes
Sample size calculation	No	No	No	No	No	Yes	Yes	No	Yes
Interim and final analysis	No	No	Yes	No	No	Yes	No	No	Yes
Results dissemination
Time for writing and dissemination of results	No	No	No	No	No	No	Yes	No	Yes
Publication fees/conferences fees	No	No	Yes	No	No	No	No	Yes	Yes

Abbreviations: PI principal investigator, CTU clinical trial unit, KCE Belgian Health Care Knowledge Centre, IMPs investigational medicinal products, AE adverse event, SAE serious adverse event, SUSARs suspected unexpected serious adverse reactions, CRF case report form

ISSN: 1745-6215