Have you ever wondered how your clinical trials end up with budget shortfalls? The culprit could be hidden costs. These costs can hide in the
- study protocol
- provider ordering practices
- staff resources
- changes in study monitors
Uncovering the hiding places is critical for study success. In this blog post, I will review some common areas where we commonly find hidden costs.
Hidden costs can hide in the footnotes of study protocol documents, such as the calendar of events. The calendar of events is a grid of tests and procedures along with the time points for each test as outlined by the study protocol. The calendar of events usually has footnotes written in fine print. The fine print includes additional details about the study tests and procedures. For example, the calendar of events grid might require an electrocardiogram (ECG) at the time points of enrollment, day 1, day 3 and day 5 of the study. The footnote might further clarify the ECGs are performed before, during and after drug infusion at enrollment and day 1, 3, 5 study visits. Without a thorough review of the footnotes, you might include the costs of just four ECGs when the protocol actually requires twelve ECGs, leading to a budget shortfall for that line item.
Hidden costs can also lurk in provider ordering practices. If the study protocol requires a blood panel and the provider places the order as separate tests instead of the bundled panel, this could increase costs and lead to budget shortfalls. I find it helpful to include the current procedural terminology (CPT) codes for each test and procedure to ensure the study team and partners in revenue cycle understand which tests are related to the study protocol. In addition, having an internal study start-up kick off meeting with the research team to discuss the study details, including the tests to be ordered, helps to align multidisciplinary team members.
Some studies are very complex and require training beyond the usual (such as required HIPAA and IRB training). For example, Good Clinical Practice (GCP) training is in addition to human subjects protection training and can take as long as 8 hours. Each sponsor has their own electronic data capture (EDC) platform that requires training on case report form completion and system access. In addition to the initial protocol training, study staff may need more time to learn how to perform data entry. In my experience, one study required over 2,000 pages of case report forms per patient. Thus, it is helpful to review the template case report forms and EDC to understand the time commitment and include the human resources in the budget to avoid budget shortfalls.
Changes in Study Monitors
According to U.S. Food and Drug Administration (FDA) regulations at 21 CFR 312.56, “the sponsor shall monitor the progress of all clinical investigations being conducted under its investigational new drug application.” In these uncertain times, staff turnover has increased among sponsor study monitors. The study site team members have to spend time orienting study monitors to the site’s policies and ways of conducting research. Each time a study monitor changes, the site has to spend more time orienting the new sponsor monitor. The new monitor often reviews all of the work completed by the previous monitor, taking more time from the site staff and potentially causing budget shortfalls in the staffing resource line item. To this end, sites should include a new study monitor change fee in their budgets to ensure the costs of time spent by study staff members are covered.
Understanding clinical trial budgeting and billing is critical to sustaining a robust clinical trial portfolio to bring new therapies to people. With the right money covering the right costs, sites can work effectively and cooperatively with their industry sponsors.
CITI Program Courses
Consider the following CITI Program course options for foundational training on the core components of the clinical research enterprise as well as the knowledge and skills necessary to maintain compliance and best practices associated with clinical research billing.