By Ray Tobey, Chief Medical Officer on Feb 28, 2018 9:00:00 AM
This blog reviews key concepts in our new eBook, “How to Budget Sites for Clinical Trials”. Click here to download your free copy.
In part II of this blog series highlighting our newly released eBook, we wanted to take a deeper dive into the specifics of each individual steps of the site budgeting process.
Clinical trials are complex and components vary, so the most difficult part of the budgeting process is getting started. The first thing you need to do is gather as much information and documentation about the study as possible. The most important document to obtain is the study protocol. This should have information on timeline, scope, patient population, procedures and personnel and equipment needs; all aspects that go into how much the study will cost. With this in mind, we’ve outlined some simple questions that you an answer that will allow you to get moving in the budgeting process.
- What is the timing and scope of the study?
- What is the expected personnel needed to perform the study? And what is the cost per hour per type of personnel?
- Where in the protocol is the information we need to determine the variables of the study?
- What are the variables of the study that affect site operations?
- Can all this information be translated into numbers for a spreadsheet? If not, how can we better quantify these pieces?
- What equipment is required to perform the study?
Building a framework
Once you have obtained all the information relevant to your trial, it’s time to organize it into a ‘framework’ or a set of spreadsheets and tables that allow documentation of a site’s role in the clinical trial process, assign unit costs to each item, and adjust unit costs should changes occur later. This may seem laborious but the goal is to determine the cost per patient or cost per patient visit.
For example, some items in your framework may include:
- The cost of personnel per visit
- The cost of equipment usage per visit
- The cost of patient transportation reimbursement
- A site’s pass-through overhead costs (such as utility and property bills)
- Accounted margin of error for variations in time spent
Once you have established the information needed in the spreadsheet to accurately obtain an estimate of costs, you can begin populating each with a specific value.
The negotiation processes
Your completed site budget will prepare you with all the information you need to negotiate with a site and evaluate if they can provide the service you need under budget and within the timeline. The most important thing to remember is that not one clinical trial or clinical trial sites are the same but the process in which to determine the site budget will rarely change.
Download the complete eBook below to learn more.