How to make a clinical trial site budget

You may have been tasked with creating a clinical trial site budget. This is a budget itemising all the costs that will be incurred at the study site.

The site budget may be needed

1. To estimate the total cost of that site running part of the trial, as part of a bid to the CRO or sponsor
2. To identify who needs to be reimbursed for each cost item
3. To ascertain whether or not it is feasible to run the trial at that site
4. To ensure that the site is reimbursed for the costs that they incur while running the trial

If you are building a site budget, the most important document is the study protocol. The protocol has a list of all procedures that the study subjects will undergo, called the Schedule of Events. Sometimes, you will not have access to the study protocol - just a trial synopsis - but in any case you need the Schedule of Events. This is the bare minimum to create a site budget.

In addition to the protocol, ideally you should have most of the following, but you can make a rough site budget without them.

• informed consent forms
• Clinical Trial Agreement (CTA)
• lab manuals
• charge master (list of fees for procedures)
• sponsor budget

The study protocol contains the schedule of events. If you find the schedule of events, you will see “procedure” in the rows and “visit number” in the column headers.

Each line corresponds to an activity. The number of X’s tell you how often that activity will take place. For example, in the above example, the patients’ vital signs will be taken seven times. So the cost per patient of the vital signs will be the cost of a single vital signs check, times 7. If this assessment costs $50, the total cost per patient in that row will be $50 x 7 = $350.

The cost of each activity can be looked up in the hospital charge master (a list of costs for that location). Some countries, particularly in Europe, have a public list of standardised costs for activities in clinical trials.

It is very important to read the footnotes as well. The footnotes may explain exactly what lab assessments will take place, and there may be more activities and costs hidden in the footnotes that weren’t immediately obvious in the schedule of events.

You may find instructions on handling the drug product in the lab manual and other documents, so ideally you will have been given a bundle of documents and you should read them to find any further activities that may not be in the protocol. For example, the informed consent form contains information on subject compensation, e.g. are subjects reimbursed $50 per visit.

Above: a protocol. Source: NCT04128579

Worked example of creating a site budget with AI using the Clinical Trial Risk Tool

You may find it time consuming and error prone to create a site budget by copying line items one by one from the protocol into a spreadsheet. Luckily, AI can make this process less painful. Using an AI tool like the Clinical Trial Risk Tool, you can simply drag and drop the protocol PDF and the budget Excel can be created, shared, and exported. Check the demo below and you can read more in our white paper.

How do I try the Clinical Trial Risk Tool?

Sign up at https://clinicaltrialrisk.org/ to try the Clinical Trial Risk Tool.

Contact us if there are any features which you would like us to add to the tool

References

1. Pfeiffer, JoAnn and Windschiegl, Marilyn with guest author Garhan, Hailey, Managing Clinical Trial Budgets & Contracts, 2nd edition, LAD Custom Publishing, Inc. ISBN #: 9 780840 174000