What is a clinical trial budget?
A clinical trial budget is a detailed itemised budget that outlines the estimated costs associated with conducting a clinical trial. This blog will start you thinking about all necessary budget expenses from trial planning and initiation to management and completion and will provide you with a few tips to help with developing your trial budget.
A comprehensive budget is critical for securing funding, optimising resource allocation and facilitating the successful execution of the trial.
The clinical trial sponsor and Principal Investigator have responsibility for ensuring the trial budget is completed in accordance with the trial protocol and funding agreements.
How do you create a clinical trial budget?
Creating a clinical trial budget involves careful planning and consideration of all costs associated with conducting a trial.
Here is a step-by-step guide with things to consider:
Identify and estimate cost categories
- Personnel: Calculate salaries for investigators, research coordinators, nurses, and other staff (such as statisticians or economic analysts). Factor in base salary, benefits and overheads.
- Consumer: Costs for actively involving consumers in the research design and paying them for their time and travel.
- Patient care: Estimate costs for participant visits. Consider diagnostic tests, hospital stays, recruitment, screening, and travel.
- Investigational products: Consider costs for drugs, devices and treatments used in the trial. Costs may include purchasing, storing, and distribution.
- Lab testing and imaging: Fees may be incurred for lab and imaging facility usage. Obtain quotes for the required tests and procedures.
- Data management and statistical analysis: Consider costs for electronic data systems, database management, and statistical support.
- Regulatory: In Australia, pharmaceutical trials incur fees for the Human Research Ethics Committee (HREC) review.
- Monitoring and quality assurance: Consider costs for site monitoring visits, auditing and quality assurance activities.
- Publication: Consider potential costs for publishing in journals, and presenting at conferences (i.e. flights and accommodation costs).
- Miscellaneous: Consider other miscellaneous items such as travel expenses and site initiation fees for multicentre trials.
- Contingency: Consider including a percentage of the total budget for unforeseen expenses or changes in the trial’s scope.
Prepare a budget spreadsheet
- Use a spreadsheet tool, such as Excel, to calculate costs.
- Break down costs into different categories such as staffing costs, costs per participant.
- Create a line item for each cost.
- Break the budget down year by year.
Review and finalise budget
- Review the budget to ensure all costs are accounted for and are realistic.
- Seek input from the organisation's governance department, finance professionals and other experienced investigators.
- Obtain quotes and approvals before finalising your budget.
Monitor budget
- Continuously track expenses during the trial to ensure the budget is being adhered to.
- Regularly compare actual expenses with the budgeted amounts. If there are any significant changes in amounts, investigate the reason why.
- If there are changes in the trial requirements and unexpected costs, adjust your budget accordingly.
Tips for creating your trial budget
- Start early!
- Talk to knowledgeable investigators and coordinators.
- Know the number of participants and, if a multi-centre trial, the number of sites needed to recruit.
- Overestimate rather than underestimate costs.
- Negotiate prices with service providers and vendors in advance.
- Where possible, use a budget template to help calculate costs.
FAQs about clinical trial budgets
A clinical trial budget is a detailed financial plan outlining the estimated costs associated with conducting a clinical trial. It includes expenses related to personnel, study procedures, site fees, patient compensation, supplies, equipment, and overhead costs.
A budget is crucial for planning and managing the financial aspects of a clinical trial. It helps to ensure sufficient funds are available to conduct the trial effectively, covers all essential expenses, and allows for accurate forecasting and resource allocation.
The key components of a clinical trial budget typically include:
- personnel costs (salaries and benefits for investigators, coordinators, and other staff)
- participant related expenses (screening, recruitment, and compensation)
- investigational product costs
- site fees and overheads
- data management and statistical services
- regulatory and compliance costs
- administrative and miscellaneous expenses.
Estimating costs involves considering various factors such as the study protocol, expected participant enrollment, study duration, site locations, and specific procedures involved. Detailed discussions with key stakeholders (such as investigators, site coordinators, and finance teams) and leveraging historical data or industry benchmarks can aid in accurate cost estimation.
To manage costs effectively, consider the following strategies:
- negotiate site budgets and contract terms
- optimise patient recruitment and retention strategies
- centralise certain study activities to reduce duplication
- use technology for data collection and monitoring
- regularly monitor and adjust the budget based on actual spending.
Budget overruns can be prevented by:
- conducting thorough initial budget planning
- identifying and accounting for potential risks and contingencies
- monitoring spending closely throughout the trial
- implementing efficient cost-saving measures when possible.
Typically, the principal investigator (PI) or sponsor of the study is responsible for managing the clinical trial budget. This involves overseeing budget development, monitoring spending, and ensuring adherence to financial guidelines.
Budget revisions may be necessary due to protocol amendments, unexpected expenses, or other factors. Any budget revisions should be carefully reviewed, documented, and communicated to relevant stakeholders to ensure transparency and compliance with financial guidelines.
Resources such as experienced clinical research organisations (CROs), financial consultants specialising in clinical trials, or industry guidelines and templates can provide valuable assistance in developing and managing a clinical trial budget effectively. Often, universities have their own budgeting tools.
Helpful links to clinical trial budget templates
We recommend checking with your organisation to see if they already have a budget costing tool or template. The NSW Health Budget Costing tool is also a great resource.
