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Clinical Trial Budget Template
Introduction: How to prepare a clinical trial budget
Preparing a comprehensive and practical clinical trial budget requires thorough planning and foresight. Budgeting is one of the first steps involved in planning a clinical trial, and is a central component of a feasibility study, which is done to ensure that the study is well positioned to successfully answer a relevant research hypothesis, within given time and monetary constraints.
Clinical trial budgeting requires extreme detail; it is not just about accounting for the obvious costs, but also includes consideration of less apparent expenses that could arise during the course of research study. It's crucial for sponsors to develop an accurate budget estimate in order to ensure a smooth-running trial, effective agreements with sites and providers, and to avoid unexpected financial stress.
As for the best way to go about preparing a clinical trial budget, there is no single answer. Depending on the sponsoring organization’s past experience and partnerships, the therapeutic area and type of study, and many other factors, the budget will reflect different expenses. Nonetheless, there are still primary cost categories that are common to most clinical studies. Thus, one option is to begin with an established clinical trial budget template, which will provide an excellent starting point for eventual customization to the specific study at hand. This option may be particularly attractive for those conducting their first trials; experienced sponsors may also have an internal budget template that they adjust for each new trial.
Of course, the budget can be constructed anew from the ground up, but it becomes even more important to carefully review it to ensure that all costs – including potential/unexpected costs (which can be significant) – are taken into consideration. The main types of expenses that should always be included in a clinical trial budget are explored in further detail below.
What should be included in a clinical trial budget?
A detailed clinical trial budget should account for various cost categories, which can be organized in different ways depending on the structure of agreements and the design of the trial.[1],[2]
Start-up (up-front) costs:
- Preparation of regulatory documentation
- Investigator meetings
- IRB submission and review
- Site selection and site initiation visits
- Storage and archiving dees
- Recruitment advertising and outreach efforts
- FDA audit fees
- Pharmacy fees and costs of the investigational product (supplies of the study drug)
Invoiceable costs (event-based) refer to aspects that may be billed on a temporal basis, either for patient care/interventions or for periodic reviews and regulatory submissions, including concepts like:
- Periodic safety reporting, i.e., the ICH E2F DSUR
- Lab tests
- Medical procedures
- General patient care
- Study-related training
- Auditing fees
Patient-related expenditures / per-patient costs are another significant component of clinical trial expenses. Some of the patient care costs categorized under invoiceable costs (above) could also be included as per-patient costs. These costs, which are directly dependent on the number of patients enrolled (or screened), may relate to aspects such as:
- Participant recruitment and screening costs (including screen failures)
- Compensation/reimbursements made to patients for their participation or for travel expenses, accommodation, etc. (as specified in the trial protocol)
- Procedures and tests (could also be categorized as invoiceable costs)
Staffing / personnel costs include salaries for principal investigator(s), nurses, study coordinators, data managers, and other personnel directly involved in conducting, directing, and overseeing the research study.
Indirect costs, or “Facilities & Administration (F&A)” fees encompass administrative overheads, as public research institutions must recover all costs of for-profit research conducted using their facilities and administrative procedures.[3] The infrastructure is usually shared between various users (both public and private entities) simultaneously, and thus they tend to be complex to calculate or predict. Indirect or F&A fees include things such as:
- data management services
- insurance coverage related to the study
- institutional overhead charges
Hidden costs: In addition to the routine operational expenses, it's vital to allocate funds towards potential contingencies which could emerge unexpectedly. These could include things such as additional monitoring visits in the case of excessive queries to be resolved or severe adverse events, re-submissions and re-consenting for interim protocol amendments, unexpected delays, or costs related to early termination (amongst many other possibilities).
What is the average budget for a clinical trial?
The cost of conducting a clinical trial varies widely according to a number of factors, making it difficult to state an 'average' budget. The cost of conducting a clinical trial is directly dependent on:
- The type of intervention being studied (investigational drug, medical device, behavioral intervention)
- The complexity of the study design
- The phase of the trial
- The duration of the study, including the follow-up phase
- The therapeutic area of the disease and/or intervention
To give a rough guideline, small-scale observational studies will typically be one of the least expensive types of trial to conduct. Based on a 2016 study analyzing data for the period of 2004–2012 in the U.S.A., approximate/average costs for interventional clinical trials according to the phase are as follows[4]:
Top cost drivers of clinical trial expenses
The same study offered further insights into clinical trial expenditure, such as indicating which therapeutic areas tended to involve more costly studies and which types of expenses were the main contributors to overall trial costs.
It was found that the top 3 drivers of clinical trial costs were the following categories of expenses[4]:
- Clinical procedure costs, representing 15%-22% of total costs
- Administrative staff costs, representing 11%-29% of total costs
- Site monitoring costs, representing 9%-14% of total costs
In terms of therapeutic area, the ranges of overall trial costs across disciplines were narrower for phase I clinical trials and phase II clinical trials, while the overall cost of phase III trials varied more significantly, with trials in the field of pain and anesthesia being the most costly.[4]
The fast route: Accelerate study start up by using a clinical trial budget template
Preparation of the clinical trial budget can be expedited significantly by utilizing a well-structured template that has been used for prior studies. A good budget template will allow sponsors to organize projected expenses in predetermined categories, helping ensure that no costs are overlooked during the planning stage.
As mentioned, each study budget is unique, so the basic idea would be to check a few of the templates available through reputed academic institutions (linked below), find one that reflects your expense structure more or less, and then customize it until it captures everything you need it to, in a way that makes the information legible and accessible for any stakeholders who may need to review it.
For organizations that conduct multiple trials, employing a standardized template also supports straightforward inter-project comparisons and facilitates auditing procedures when necessary. If you’re conducting your first trials, pay attention to what works and what doesn’t work in the budget template, and refine it for subsequent studies.
See the following section for direct links to a few clinical trial budget template excel spreadsheets, which can be used directly, customized, or simply used to gather ideas for generating your own budget from scratch.
Clinical trial budget example templates
Some great examples of clinical trial budgets can be found at the following resources. Note that most of these are direct download links to clinical trial budget template excel sheets (clicking them will open the dialogue for downloading the budget template directly to your computer).
1. University of Tennessee Health Science Center (UTHSC): Sponsor study budget template
https://uthsc.edu/research/sponsored-programs/agreements/documents/budget-template-010909.xls
2. Oregon Health & Science University (OHSU): Study budget template https://www.ohsu.edu/sites/default/files/2019-05/budget_template.xls
3. University of Arizona: Industry-sponsored clinical trial budget worksheet
https://medicine.arizona.edu/sites/default/files/study_budget_spreadsheet_templates_and_sample.xls
4. Virginia Commonwealth University: Industry clinical trial budget template
5. Smartsheet’s Clinical research budget template
https://www.smartsheet.com/sites/default/files/2020-03/IC-Clinical-Research-Budget-10628.xlsx