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Table 2 Simplified example based on the use of the budget tool (version 4.0)

From: Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency

Project design and set-up

€84,825

 - Development of budget and study protocol (including amendments, consent form and any questionnaires), risk assessment and management plan, contracting with funder and vendors, initial selection of sites/GPs

 - On-site feasibility check (per site, for 50% of the sites)

 - Remote feasibility check (for other sites)

 - Negotiation of site agreements

 - Subcontracting with tender

Regulatory authorities, ethics committees, insurance

€29,835

 - Submission to the leading ethics committee

 - Submission to the ethics committees of participating sites

 - Communication with ethics committee per study year

 - Submission to regulatory authorities

 - Communication with regulatory authorities per study year

Study monitoring

€266,079

 - Development of a monitoring plan, risk-based

 - Study monitor familiarisation with trial

 - On-site initiation visit, monitoring visits, closure visit

 - Fixed average transportation fee per on-site visit

 - Remote monitoring visits

Quality assurance

€7020

 - Sponsor audit on site 2 days by independent auditor; includes visit, preparation and report

Trial master file (TMF) & administration

€66,234

 - Set-up of (electronic) TMF

 - Set-up of investigator files, 4 h of clinical trial assistant per site

 - Maintaining files, 12 h of clinical trial assistant per site per year

 - Sponsor making payments to the sites, 1 per site per year

 - Archiving, 2 large boxes plus 1 per 4 sites for 25 years

Safety monitoring and expedited reporting

€14,040

 - SUSAR documentation and expedited reporting

 - Data safety monitoring board (DSMB) meeting (1x/year)

Data management

€141,570

 - Data management plan, database and electronic case report form (eCRF) set-up for comparative effectiveness trial

 - Import, validation, coding, query management per patient (2 h per patient)

Statistics, report and publication

€58,500

 - Statistical analysis plan, randomisation plan, programming

 - Statistical analysis and clinical study report

 - Publication, including open access fee

Project management

€367,497

 - Trial management group meeting (2x/month until end of recruitment, monthly thereafter)

 - Trial steering committee meeting (3x/year during first year, then 2x/year)

 - Investigators meeting, at study start and end

 - Project manager time per year: 0.2 full-time equivalent (FTE) + 0.025 FTE per site

Patient and public involvement

€6552

 - Participation during study design and set-up phase

 - Participation of 2 representatives in steering committee meeting

Study intervention/investigational medicinal product (IMP) handling

€152,340

 - Purchase of intervention/IMP/placebo, blinding, packaging, labelling, recovery and destruction of unused product

 - Storage and distribution

 - Central randomisation system and unblinding if applicable

Site costs

€518,310

 - Start-up fee

 - Per patient visit 2 h study nurse and 10 min clinician time + 30 min clinician time at first visit

 - Lab sample whole blood at 5 visits for central lab

 - Local pharmacy costs for transfer study

 - Archiving box for 25 years

External vendors

€0

 - Study-specific equipment or external services are already included in the IMP budget

TOTAL BUDGET without value-added tax (VAT)

€1,725,672

TOTAL BUDGET with 21% VAT

€2,088,063

  1. To calculate the budget for this study, we took into account the following study parameters: 20 sites, 400 patients, 7 visits per patient, recruitment period of 18 months, treatment period of 24 months, total study duration of 4 years, 5 on-site monitoring visits and every 2 months a remote monitoring visit, 3rd party placebo development, packaging, labelling, distribution