Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. This installment in our Clinical Research 101 series is by Leslie Love, Senior Project Manager at Advancing Health. Ms. Love is a certified clinical research professional with over 25 years’ experience in a variety of research settings, including at the site level, with sponsor-investigators, and at contract research organizations. The following is a brief discussion of how to budget as a site for a clinical trial.
Money makes the world go ‘round, goes the old saying, and the same can be said for clinical research. Creating accurate budgets in clinical research that reflect all items in the study protocol and the time needed to complete these items is an essential component of study management. However, calculating these expenses can be one of the most daunting tasks undertaken by clinical research staff.
Before starting a study, it is important to accurately estimate the amount of staff time and other costs to be incurred by the unit or department that is acting as a study site. If contract or ethics review drags on, or enrollment is not as fast as expected, sites can quickly fall behind and end up in a deficit before the first participant is enrolled! Additionally, there are often significant “up front” costs involved in getting a study up and running (see details below). In order for a clinical research site to be sustainable, it is imperative that all possible contingencies and expenses be included in the budget.
Creating a research budget
Some expenses may seem to be quite straightforward: a lab test, or a medical test can be easily calculated based on the institution’s standard fee(s). However, it is not quite that simple. The lab may only bill $20 for a specific test, but the test itself is but a small component of the study procedure. The total budget expense for this test should also include: site staff time to order the test, escort the participant to the test area, enter the data in the study database, and to file the results. One of the study physicians is required to review the results. If the results are abnormal and considered “clinically significant”, there may need to be further follow up by the study investigators. A clinically significant lab result may indicate an adverse event, which requires further time and documentation by study staff. Research staff time must be included in estimating the cost of any study procedure. In some cases, physician and staff time may be listed as a separate line item in the study budget.
Sponsors must provide funding for any protocol requirement that is over and above standard of care. During a review of the protocol, it is important to identify which costs are related to research, and which are not. For example, if a specific lab test is done on a quarterly basis for clinical reasons and is also included in the protocol at the same frequency, only one tested is usually needed and the results can be used for clinical and research purposes. (Note that this is always protocol dependent.) If the protocol requires that the test be completed more frequently than the standard of care, or includes additional types of lab tests, this would be considered research, and should be billed to the sponsor.
Types of Expenses
There are typically four types of expenses associated with clinical research:
- Study Start Up Expenses: These should include all tasks associated with starting up the study, including creating study documents (e.g., informed consent forms, recruitment materials, data collection work sheets), Research Ethics Boards submissions, contract negotiations, all departmental set-up fees (e.g., pharmacy, lab, imaging), training on study materials/tasks, in person or remote meetings, and setting up the documents and materials in preparation for the first study visits. This type of expense is usually a non-refundable payment for work undertaken before the study starts. Additionally, archiving of study documents is often included in the study start-up expenses.
- Per Participant Expenses: These costs are based on each study procedure and the related tasks associated with this procedure.
- “Pass-Through” invoiceable expenses: These are for tasks that may or may not occur, but the costs need to be recovered from the sponsor if they do. REB amendments and annual renewals, procedures related to serious adverse events, time for monitoring or auditing visits, participant compensation, pharmacy maintenance fees, advertising and translation of study documents are just a few examples of pass-through costs. Costs related to closing out the study are often included here as well.
- Institutional overhead or indirect costs: Indirect costs of research are operating expenses that support research but cannot be wholly attributed to any one research project. Many of the indirect costs are incurred whether or not research funding applications or proposals are successful, or the research starts. These are usually a percentage of the study budget, and vary by institution and funding source.
Hidden Expenses
Hidden costs are expenses that often aren’t considered in the overall budget. They may include some of the items listed in the pass-through expenses above, but can also be expenses specifically related to the protocol. One example is phone call follow up, including the time needed to get in touch with the participant. Other examples include unscheduled visits, cost of dry ice or couriers, speciality equipment training, cost of living increases for staff if this is a long-term study, re-consenting participants when consent forms are updated, time for shipping samples or study drug, and screen failures. It is also very important to know the screening to enrolment ratio for your study population: if the study has very strict inclusion criteria, you may need to screen many individuals before actually enrolling a participant. In these cases, it is imperative to account for the screening activities separate from enrolment and follow up visits.
Other Things to Consider
When investigators take on the role of sponsor–investigator, where they act as the sponsor and the investigator at a site, the costs associated with running the study across one, or multiple sites, need to be included in the budget. We will discuss more about this in Part 2 when we cover Funding Models.
This site budget template includes each of the types of expenses listed above, with a suggested listing of items to include; this list is not exhaustive — the procedures and additional costs will vary per study.
Stay tuned for Part 2 of Clinical Research 101 Budgeting where we will discuss funding models and negotiating a study budget.
Resources:
- Developing an Investigator Site Budget for Clinical Trials. Journal of Oncology Practice. 2007 Mar;3(2):94-7.
- How to Negotiate a Clinical Trial Site Budget, by Sue Willems and Judy Needham, CRPBC Presentation
- Budgeting and Indirect Costs, UBC Research + Innovation
- Schedule of Standard Costs Template
If you have any questions, please contact researchsupport@advancinghealth.ubc.ca and we can assist you.
