Challenges with Budgeting and Analytics in Trials

ACT: What are some challenges that stakeholders are currently seeing with budgeting and analytics in their trials?

Murphy: Well, the budgeting process has got a lot of different challenges to it, particularly in the area of patient related spending because there isn't really great data as reference to drive those planning decisions. Everybody starts with an idea of a draft protocol and then models out their expected costs and whatnot, but in patient-specific spend, this concept of patient travel reimbursements for out of pocket expenses and stipends as applicable—it's really hard to know because there's no reference data, so people are called on to just use what they used on the last study and that is generally bad because the conditions of enrollment are changing dramatically, and people are traveling further and then there's inflationary pressures on top of that, which makes it so much more complicated. Meal expenses have increased 30 to 45% depending on geography around the world over the last few years.

The bottom line is startup is always an urgent process, it moves quickly, everybody's trying to get everything done very quickly. There isn't a whole lot of time for people to seriously ponder the implications of patient-related support on the overall cost of the budget. As a result, it sometimes gets incorporated either as an afterthought or as a one size fits all approach which is not applicable or not effective and you end up having to come back and do changes—changes in services being brought in, changes of informed consent to amend it for different conditions. Ultimately, they say a stitch in time saves nine—if you really want to go quickly, you have to spend the time to think about the population and be able to have some reference insight to be able to guide good decisions on how you set things up from the start.