Tufts issued a report this week to the effect that 25% of study procedures were unnecessary and that we could do much better on study costs (saving as much as $5 billion) if we eliminated these expenses.1 I guess hindsight is great about what’s really necessary, but the bottom line is that somebody at some point usually thinks that the expense is justified, especially if it’s early exploratory evaluations.
But there’s an elephant in the room: the basic inefficiencies in how we execute research. Our industry recruits studies late 85-90% of the time. We spend one-third of study budgets on monitoring, which produce little value yet consume enormous (and disproportionate) resources. We also spend roughly a third of study budgets redoing work that wasn’t done right the first time. How many industries could survive with this kind of dismal productivity?
Fortunately, there are some good answers to these issues. I divide the general issue of productivity into operational issues, which are those discussed above, and design issues, which are how we assess. The element common to both is the ability to quickly ascertain what is going on and how to address the issue. This sounds pretty simple, but I challenge anybody in our industry to be able to determine quickly and objectively why, for example, a study is enrolling poorly.
When I ask about how individuals address the common issue of enrollment the nearly invariable response is, “I call the sites and ask them how we could do better.” But why would sites, often medical personnel who are not selected for their managerial capabilities related to broad study issues, know why people aren’t coming to the door? And if the success in enrollment is the measure of success, then our inability to budge this 10-15% on-time rate suggests that it’s not working—or even making a dent in the problem.
I believe the answer rests on most basic management questions:
- How do I get people to the door?
- Once they are there, why don’t the get into the study?
- Once they’re in the study, why do we lose them?
There are answers to all of these, and systems that immediately provide the answers. These systems have reliably results in 83% on-time or early recruitment and run circles when gone head-to-head against the current model that is slow to identify problems and slow to provide the information needed to address them.
Rather than $5b, this would save the industry about $1.6 trillion. That sounds a lot more appealing—and doable—to me.