For the majority of medical device sponsors, conducting a clinical trial comes at a huge cost, consuming most of a typical company’s R&D budget. The importance of putting together a precise forecast of potential spend is essential as an inaccurate study budget could have damaging implications on the trial in question. What’s more, a failure to manage all costs would do little to enhance the credibility of an industry renowned for large expenditures on clinical research.
For the person responsible of developing that budget, they are tasked with an onerous challenge. To start with, there are many unknown variables, putting the gatekeeper at an automatic disadvantage as it becomes difficult to accurately estimate the final budget. Even with a draft trial design in place, there are many factors that make it difficult to determine the final forecast, such as rising inflation for a trial that will last over a number of years. So what are key things to consider when planning a budget? Here are four tips:
1) Determine the Scale of Work Needed at Investigational Sites
First things first, ask just how much work is required at each investigational site. This can be done with the aid of site staff members. From there, ensure a fair market value is paid to sites for the procedures that are carried out. Once you have an idea of the expenditure required at one site, you can then extrapolate that figure and apply to the number of sites needed in one country, adjusting the numbers according to each country that’s included in the study. Bear in mind, while it might be easy to adopt the approach of overestimating to cover all bases, over budgeting a trial can be just as damaging as under budgeting one.
2) Account for Work Done Internally and/or by the CRO
In instances where the sponsor is conducting the trial wholly in-house, the budgeter must account for internal resources in the forecast. In the event the study is partially or fully outsourced, the budget needs to factor whether the CRO charges in units as tasks are completed, or according to the number of hours worked on the trial. Accounting for the latter is especially challenging as what may be estimated could be completely different from the actual cost. Therefore, it’s always beneficial to have in place an emergency fund for extenuating circumstances.
3) Define What Constitutes ‘Standard of Care’ and What Doesn’t
When preparing the budget, be sure to clarify what constitutes services that are deemed standard of care and those that aren’t. If certain activities are regularly carried out throughout the course of the treatment then that is regarded as standard of care. Procedures that are performed to in keep with the larger research goals are not. For the procedures that are standard of care, the budget should account for the time research coordinators and or physicians spend during the trial.
4) What are your Hidden Study Costs?
Finally, there are numerous study costs that oftentimes aren’t considered when drawing up the budget. Some of the hidden study costs that can make or break a trial include:
- Delayed study starts
- Enrolment rate changes
- Increased operating costs
- Travel costs
- Administrative fees
Source: Elke Sommerijns
What’s more, be aware of the indirect study costs a clinical trial can incur as they can have a telling impact on the overall budget. Research sites sometimes feel this is an issue that can go overlooked by the sponsors. Be sure to list all items that could be deemed a fixed cost as they can be forgotten. Examples of fixed cost items include:
- Laboratory testing
- Pharmacy charges
- Shipping fees
Source: Elke Sommerijns
Be sure to keep tabs on study payments and costs in efforts to keep the budget current. Change orders, sometimes a necessary evil, are required in clinical trials, but if the budget is closely monitored they can be avoided.
Ultimately, planning the costs of a clinical trial is an arduous process that’s ongoing. Although a challenge, developing an accurate budget can pay dividends in the end.
*Adapted from How to Budget a Clinical Trial for Medical Devices by Elke Sommerijns