Clinical trial budgeting is an essential aspect of running a trial successfully. A clinical trial budget is the estimated amount of money you need to complete the clinical trial. Let’s understand how you can do budgeting effectively.
Types of costs and cost buckets
Trial budgets can be broadly divided into two categories — overall budget and site budget. If you have multicentre trial sites, you need to budget for all the sites, and at the same time, you need to manage the cost for single sites. For example, you need to consider per patient enrolment cost, the cost for starting up of trial, and study close out cost. There are overhead costs too, that needs to be budgeted. Cost buckets need to be determined, also, while budgeting for clinical trials. Some of the standard buckets are technology, travel and meeting costs, data management support, manpower cost, study intervention, study-related care, etc.
Things to remember while budgeting
Remember, you need to know the scope of work well when defining your budget. For example, how many patients would you need to recruit? Are you going to invest in any new technologies? Who is running the trial, and what are the expenses for them? How many sites would be needed for patient recruitment? Knowing all of these would help you budget more effectively.
Remember that every task and data point will cost you money, so allocate them in your budget. Also, give careful consideration to the data points needed because minimizing data points not only makes your trial easier but cost-effective too.
Underestimating time or sites to recruit may cost you more. If you need more sties later, cost them up before you startup.
Developing a CT budget: A quick note
While most trial researchers take note of personnel costs, some still miss out on other critical costs for conducting a trial which may overshoot your expenses. Here is a quick list of the most missed out factors in a clinical trial budget.
Regulatory costs: Your trial budget should include regulatory fees, i.e., the costs involved in submitting the trial report to the regulatory authorities, clinical trials registration, etc. Have these included as regulatory costs in your final budget.
Allocate for safety costs: Although uncalled, adverse events can happen anytime. It is essential to evaluate adverse events and budget those costs. For example, costs that you may incur from adverse events can be medical follow up, appointing safety oversight committees, generating safety reports and ad-hoc meetings, reporting safety issues to regulatory agencies, etc.
Costs for data and quality management: These are the costs you will incur for clinical monitoring like ongoing site monitoring visits, site visits, initiation visits, etc. These will also include costs for project management, quality management, data management, fees for biostatistician, etc.
Other overhead costs: In addition to all of these, there are additional overhead costs too. Some of these could be costs for advertising and patient recruitment, charges for shipping and storing investigational products, investigator meetings, travel costs, document translation costs, etc.
Site costs: Allocate funds for site startups, administrative costs, fees for adding or removing sites, storage fees for trial records, site overheads, etc.
Consider cost for the unexpected: No matter how much you plan, there can be some unexpected costs that can involve protocol amendments, a slow enrolment process, and several other contingencies that are unforeseen. So, set aside an amount that can take care of these unexpected costs.
Budgeting is a critical factor in conducting clinical trials effectively. Thankfully, a robust budgeting software solution can help you budget more accurately for your clinical trial programs.