Developing Clinical Trial Budgets, Considerations, and Best Practices

February 15, 2023 - Despite having a high risk of failure, the clinical trial process can cost millions of dollars to complete. For clinical research organizations and sponsors, a clinical trial budget is critical in determining whether a clinical trial is worth funding. Many sources provide some best practices for developing a budget; however, all budgets will look different. Although budget variations depend on the study type, size, location, and intended clinical target, every clinical trial has to consider similar factors, including start-up fees, data collection, patient care or procedures, personnel, and site costs.

According to a study published by Grand View Research, the clinical trial industry was valued at $47 billion in 2021, with an estimated annual growth of 5.8% between 2022 and 2030. This value can be attributed to multiple factors, including the average cost of launching a medication or conducting a clinical trial. An article in Mosio notes that developing and launching a new medicine or therapy can cost over $30 million from conceptualization to market approval.

Considering the extraordinary costs associated with clinical trials, an appropriate and realistic budget is necessary. Clinical trial budgets are complex, containing many variables. However, they play a critical role in getting funding for or deciding when to fund a specific study.

According to a presentation by the NIH — in collaboration with the University of Cincinnati and the Medical University of South Carolina — a trial budget is defined as “the estimated amount of money that you need to accomplish the goal of a clinical trial or study.”

While sound scientific backing is essential for clinical trials, a clinical trial will only get the funding it needs with a reasonable and equally sound budget. The principal investigator (PI) and their team or the trial sponsor can develop a research or clinical trial budget. Regardless of who creates the clinical trial budget, it is vital that the budget is realistic and accounts for as many circumstances as possible.

For the PI, developing a clinical trial budget can bring them one step closer to funding from sponsors. Meanwhile, sponsors can determine whether a clinical trial is feasible by reviewing budget statements. Budgets are often negotiated between sponsors or industry leaders and the research team. For researchers requesting additional funds, preparing a proper budget and including supporting documents make them more likely to obtain the funding they need.

Budget Types and What They Address

The best practice for developing a budget is to create a comprehensive study or trial budget and then break down costs by year.

The presentation from the NIH also divides budgets into two types: an overall and a site-specific budget. The overall budget refers to the budget for the entire multicenter trial or a single-center trial. The main PI usually manages this budget for the study. A site-specific budget refers to the budget managed by the local site PI and includes the start-up costs, spending per patient, and the cost of closing out the study.

A clinical trial budget should address numerous vital questions including, but not limited to, the following, as clarified in the NIH presentation:

• What is the clinical question?
• How many patients and sites are needed?
• How long will the study take?
• What types of measurement will be used?
• What are the per-patient costs?
• What personnel is needed, and how much will they be paid?
• How much will the technology cost?

Factors to Consider in a Clinical Trial Budget

In an article by the HHS, the organization notes that clinical trial budgets can be divided into four primary parts: protocol design and development, data capture and storage, analysis, and data dissemination.

The protocol design and development includes consulting subject matter experts, background preparation, document preparation, sample size calculations, legal documents, approvals, oversight, and personnel training. Data capture and storage should account for database preparation, security protocols, personnel, location, supplies, processing, storage, and tracking for each visit. Analysis costs should include the salary of the person doing the analysis, the preparation of data sets, and the analytical methods used. Finally, data dissemination should account for any costs associated with presentations, publication, and data sharing.

Other sources, including a presentation for the Boston Medical Center, divide the budget into start-up costs, per-subject costs, and invoiceable costs. No matter how a PI or sponsor chooses to divide their clinical trial budget, some factors must be considered across all clinical trials.

Administrative or Start-Up Fees

Start-up costs may include IRB preparation and review, regulatory document preparation, FDA audit fees, administrative fees, and more. Other expenses to include in the budget are pharmacy fees, ancillary reviews, and institutional CMS analysis. Typically, these fees are under $5,000 per site. However, these types of one-time fees can vary based on the kind of trial, the location, and more.

Time and Sites

Sites are another crucial factor to consider when developing a budget. When creating a budget, it is essential not to underestimate the time and number of sites to recruit. Underestimating either of these factors could result in a smaller budget than necessary, leading to incomplete trials. For example, if a study’s budget projects a three-year timeline and the investigation takes five years, it will run out of money.

Underestimating trial sites can prevent trial leaders from adding additional sites later in the trial. If the starting number of sites has been unable to gather sufficient data and there is no funding to add other sites, the study will likely fail.

Data

Gathering and analyzing data is a large part of the clinical trial budget. The volume and type of data collected during a clinical trial significantly impact the budget and the money allocated to the research. It is important to note that more data often means more lavish spending. Minimizing the number of data points may decrease spending; however, it may also reduce the validity of the trial. Therefore, it is critical for PIs and the team planning the budget to determine what data adds value and what is superfluous spending.

Furthermore, the kind of data collected significantly impacts the budget. For example, imaging is the most expensive and often the most time-consuming testing method. When designing a trial and its budget, PIs may consider alternatives to imaging if possible or minimize the imaging frequency.

Another data consideration is the tools and time needed to analyze the data. If specific technology or licensing is necessary, that may account for higher costs. Additionally, if the data is difficult or time-consuming to analyze, the analysis cost will be higher.

Procedures and Patient Care

Another component of clinical trial budgets — arguably the most considerable — is calculating the cost of procedures and patient care. According to the NIH, procedure costs are calculated based on a pre-determined federal rate. When budgeting, PIs or sponsors should look for the appropriate CPT codes to determine costs.

It is important to know that the budget should differentiate between research costs and standards of care (SOC). SOCs are routine treatments or medical expenses that a participant would have regardless of clinical trial participation; however, they may vary depending on the state and other factors. Irrespective of where the trial takes place, standards of care are typically billed to the patient or their insurance.

Research costs are non-routine charges or expenses that the patient would not receive if they were not a part of the trial. These expenses are covered by and billed to the sponsor.

Another factor to consider in the clinical trial budget is the cost of the medication or therapy — and the placebo if that is part of the trial design. When calculating the medication budget, the PI must account for medications needed per person. Beyond that, they must consider what happens if they do not meet the recruitment goal and medication is wasted.

In addition to the value of the medication or therapy, budgets should include transportation costs for medication, determining whether the drug needs to be shipped in a temperature-controlled environment, and the cost of blinded packaging if that is a part of the trial design.

Other patient-centric factors to consider are patient compensation, the type of patient recruited, transportation to and from treatments, cost of patient monitoring, and so on.

Personnel

In addition to the costs of running the study, it is critical to include personnel salaries or rates in the budget. One recommendation to keep costs low is to hire coordinators and staff in contract positions and pay them hourly instead of hiring for salaried positions.

The reasoning provided by the NIH presentation is that, if you hire and pay a full-time worker but only get a fraction of the anticipated participants, there will be no money left over to pay staff down the line if more participants are recruited. This philosophy may be applied to certain types of workers; however, PIs, key personnel, managers, and data management staff are typically employed full-time and salaried.

General Guidance for Developing a Clinical Trial Budget

Those less experienced in clinical trials and budgeting may consider talking to experienced PIs, researchers, and coordinators who can give a more accurate estimate of certain costs. Those who have conducted clinical trials before may consider reflecting on previous spending.

Some general tips given by the NIH Stroke Net presentation include the following:

• develop the budget early
• get advice from experienced investigators and coordinators
• collaborate with coordination and data management centers
• have a good understanding of the number of patients and sites
• use technology when necessary, but be mindful of using it in unnecessary situations, as it can be costly
• overestimating is better than underestimating