Budgeting for a Clinical Trial

Abstract

Physician scientists are naturally curious and adventurous. When it comes to finance, however, many otherwise savvy and capable individuals shy away from budgets and financial matters. In planning a clinical trial, however, the budget process is integral to the overall planning and execution of a clinical trial. Sometimes, the ideally constructed treatment arm or the ideal control group represents a financially unobtainable quest, but a surrogate end-point or a different comparison regarding variable type can yield sound answers and be within financial reach. An experienced clinical trialist has an eye on the budget from the very beginning, while the project is on the drawing table. Much in the same way that we emphasize early biostatistician involvement, financial issues should be thought of in lock-step with trial design. In this way, the process is much like building a home. In the design phase, we might have certain goals and wishes that are simply outside the affordability range and so we change the plans in some way to provide a great home and one that we can afford. The bulk of expenses in a clinical trial are generally related to personnel costs and the costs of non-routine clinical care. The latter is a variable cost that rises with the required sample size. In addition to these costs, it is important to remember in large, multicenter trials that travel and related expenses for training at each site and for a DSMB meeting at one or two pre-specified points in the trial must be accounted for in the budget. The last major component is the safe-guarding, storage and ultimately the analysis of the data. These costs balloon with increasing numbers of data points and so seeking only that data which you might reasonably need to render a solid conclusion is a cost control measure. The costs of analysis are partly borne within the personnel costs in the form of salary to biostatisticians, but some costs for analytical software, web-based collection, and cloud computing are all in addition to the professional input and represent substantial budget items in the modern era.