Not too long ago I ran across an
article with this summary near the top, just in case I didn’t want to read
the whole piece: “Clinical trials are in need of a digital makeover.”
My first thought was that’s exactly right. But then I began
to think about that statement a little more. And that led to a more troubling
thought: Why has it taken so long?
We have been talking about moving clinical trials into the
digital age for some time now. Even back when I was leading a startup doing
electronic data capture in clinical trials nearly two decades ago, there were
many promises that technology was about to lead to great improvements in the
way new drugs are studied and ultimately brought to market.
It may have taken longer than it should have, but I believe
we are on the cusp of breaking through the obstacles to advancing clinical
trials through digital platforms and technologies.
I see three big hurdles to widespread digital adoption, and
I think 2 ½ of them have been cleared:
- The clinical trials technology field has done
its part by developing many types of solutions for tech-enabled outcomes,
including those that enable true patient centricity.
- The FDA has done its part by endorsing new, more
efficient approaches such as siteless trials and real-world evidence and data
that depend on technology.
- The pharmaceutical industry now needs to do its
part and recognizes that it needs to do so. That’s half the battle.
The fundamental problem is that the industry is simply slow
to embrace change. This is not surprising for a regulated industry. Partly
because of the need to change long-standing processes, and partly out of fear,
clinical trial sponsors so far have failed to take full advantage of solutions
that bring greater efficiency to the costly and time-consuming process of conducting
Those solutions do exist. In just the last few years,
hundreds of technology providers have emerged to help move the industry
forward. All of the ones that I’m familiar with have solutions that either improve
processes, reduce costs, improve patient outcomes, or in some way bring greater
efficiencies to clinical trials. At Spencer Health Solutions our focus is on bringing
adherence and engagement rates to trial sponsors.
We should be clear on one thing. No one is advocating digital adoption just for the sake of embracing the latest and greatest technologies. Digital adoption is meant to reduce the cost of a trial and the time needed to achieve validated results and to ultimately get to better trial and patient outcomes.
Looking for Small Wins
So where does the industry go from here to clear the final hurdle? In my conversations with drug companies, clinical research organizations and others, I’m seeing a lot more willing to follow a classic path for industries and companies that must embrace change on a large scale: Start small, and turn quick wins into bigger wins. I think this is a great approach that will serve the industry well.
For example, at Spencer, we are doing some work with a pharmaceutical company’s innovation lab. They were eager to start a pilot program, and when that’s complete, they’ll use the results to determine whether and how to scale it.
Also, I recently met with a university researcher who has a big
medication adherence problem in a trial he’s involved with. Patients are having
a hard time dealing with the medication’s side effects. I suggested he consider
a pilot program with the drug company he’s working with, and he saw the
potential in doing something small and seeing if it works.
These are just two examples of how the conversation is
turning toward making digital adoption happen. Really, the hard work isn’t in
using new technology to solve old problems. The hard work is in embracing
change and in creating an environment where change can happen quickly.
The good news is it’s possible to find that path forward by building
on small wins and ultimately turning those into successes that can scale.