In discussions about an upcoming study, a client expressed concern about startup timelines and especially enrollment. The client said, “I’m afraid that by the time we get our first report on enrollment, we may already be in trouble and be playing catch-up for the next two years.”
Based on traditional approach to studies, this client’s concern was right on target. Usually by the time poorly-performing sites are identified, you begin thinking about action (usually, and yet oddly—the response is to call sites and ask them how they can do better. If they knew, they probably wouldn’t have the problem to begin with).
Managing enrollment demands that you assess your situation daily, practically with every tick of the clock. You’re managing a project as big and complicated as building a big ship, and there is simply no way to get everything right the first time. That’s why ships have sea trials, but they have the luxury of weeks to months to correct problems. Building USS Clinical Trial that way results in the problems we already recognize: 85% of studies enroll late, resulting in cost overruns and diminished NPVs.
There is a better way, one that incorporates streaming information to quickly identify and manage the inevitable enrollment issues that arise. Building the next-generation USS Clinical Trial will still take meticulous planning and construction, but it also requires something very different—immediate information and the mechanism to make continuous small changes in response. Everybody builds the same ship, but the truest test of success is how quickly that ship can refine everything that makes it run.
Here’s how to build the next-gen USS Clinical Trial:
- Assume your ship won’t slide down the stays as a perfect ship, first time (think poorly performing sites);
- Assume that unforeseen issues will pop up, like squalls and occasional rocks that weren’t on the charts. You need a nimble ship, one that can shift directions quickly when you learn something new (think changing advertising, in- and exclusion criteria, replacing the poor performers);
- You need a ship with instruments that tell you your exact position at all times—you can’t steer the right course if you don’t know where you are. Think about what information you’re going to need to steer the ship (think individualized dashboards, with predictive capabilities);
- Think about how to act quickly to avoid hazards—the unforeseen problems that can drift into your path and put the whole ship in jeopardy (remember the Titanic?). You need a way to identify the location of known icebergs, but you also need a way to predict where they may be in the future (think predictive capabilities).
The USS Clinical Trials is a big ship but if you think ahead, ensure a stream of all the timely information you’re going to need and manage proactively, the USS Clinical Trial can be a big nimble ship.
Now I know what you’d be thinking: sure, nice, but maybe in the future. Poor enrollment is a fact of life. But you’d be wrong. The proof: one company (hint: one I know quite well) has over the past five years enrolled 83% of its studies on time, as contrasted with only 10-15% for our industry as a whole. Okay, different therapeutic areas, geographies, many other factors affect this, but regardless, you have to manage your way to enrollment success.
This exists, today, and has been in use for more than ten years, continually refined just like the USS Clinical Trials. I’ll see if you can figure out where to find this ship hiding.