How do Study Sites Prepare a Clinical Trial Budget?

Budget planning is crucial when taking on clinical trials. Effective planning means preparing well financially. A trial budget is defined as the estimated amount of capital required to accomplish the goal of a study. Study budgets are prepared each study year, considering study tasks and patient recruitment.

There are many different factors that are part of a clinical trial budget. The first major factor is the research staff, who are paid to work on the study. Another factor is technology, an inevitable cost in a rapidly advancing world of medicine. Study related care and intervention, statistical and data analysis support and any traveling are all items to take into account. Each factor plays a unique role in a study and must be added to the budget.

Two types of trial budgets exist, an overall budget and a site budget. The overall budget becomes relevant when a study runs out of an exclusive study site. A site budget is for a multisite study with a sponsor company that pays for trial start-up, per patient enrollment and finishing a study (study close-out). Sometimes a site budget is fixed and sometimes there may be room for negotiation between the principal investigator and industry.

The National Institutes of Health (NIH) gives guiding principles for trial budgets. An example is that every task and data point collected cost money, so it is best to minimize data points and only record what is truly necessary. Also, it is important to never underestimate times and sites to recruit. Overestimation in this category will prevent exceeding the budget. Other principles are to pay for time to do a task instead of full-time equivalent (FTE), and to talk to experienced coordinators for estimates of times for specific tasks during the course of a study.

Devising a budget is complicated, and for this reason study sites maintain staff members with experience in finance, so that the principles such as the ones written by the NIH are followed. Simply “winging” a budget will certainly not succeed, and investigators and research teams must be meticulous when financially planning for any clinical research endeavors.