The Bywater neighborhood in New Orleans is home to a large concentration of artists, so not surprisingly, its roads are decorated with interesting street art and other visual stimulation. For this reason, I often choose a running route through the Bywater. The pace of running, combined with limited distractions, allows me absorb aspects of the neighborhood that I wouldn’t necessarily notice in a car.
On these runs I often pass a painted sign that has popped up in various places throughout the city in the last few years, including the Bywater.
Like many people, I enjoy exercise as a way to clear my head of distractions, mentally recharge, and ponder solutions to whatever challenges I might be facing. So this sign hits me at a very opportune moment, when I have a chunk of time to consider its implications.
And the potential implications are many, none of which the artist intended to be applied to clinical trials recruitment I am sure. But since this blog often focuses on patient recruitment, that’s exactly what I intend to do in the following paragraphs.
Entrenched Clinical Research Industry Procedures
The clinical research industry favors conservatism, and the patient recruitment arena is consistent with that mentality. Some of this cautiousness is necessitated by a strict regulatory environment, but I don’t think regulatory considerations warrant the level of cautiousness and lack of innovation that is common to the industry.
We tend to put procedures in place with little willingness to later revisit those procedures or the assumptions on which they are based. In some cases, these procedures are not questioned without overwhelming evidence that they are flawed or antiquated.
If clinical research industry procedures and conventional wisdom were sources of wildly efficient clinical trials, this resistance would perhaps be warranted. But given industry challenges, particularly in patient recruitment, we would certainly benefit from a greater willingness to revisit common conventions and the assumptions on which they are based.
Clearly, we could be doing some things better, which is why it’s especially important to think that we might be wrong in some areas.
Visible vs Invisible Patient Recruitment Assumptions
Some assumptions are visible, but due to a variety of reasons, we are often unwilling to challenge them. Visible assumptions are fertile ground for small innovations.
For example, a CRO may regularly give research sites a $5,000 budget for patient recruitment. Perhaps the CRO notices that this procedure was put in place when patient recruitment was less expensive, so it reconsiders its assumption about the cost of patient recruitment for research sites. To determine if $5,000 is still the optimum recruitment allotment for sites, the CRO experiments with a $7,000 budget on a limited scale and tracks the results.
Invisible assumptions, on the other hand, are often not challenged because we are unable. In this instance, the clinical trials processes that we have adopted are so entrenched that the assumptions on which they are based become invisible to most people most of the time.
Invisible assumptions are difficult to identify, which makes them the most fertile ground for big innovations.
As an example, an invisible assumption that has recently been challenged relates to Pfizer’s at-home clinical trial. In fact, many assumptions were challenged during the development of this clinical trials model, but the reconsideration of one big assumption forms the basis of the model, which is that clinical trial participants need visit a research site. Before Pfizer’s formulation of an at-home model, this assumption was largely invisible to the clinical research industry.
Andrew Carnegie and Future Patient Recruitment Best Practices
I certainly can’t predict whether challenging the assumptions used in the preceding examples will lead to immediate success. Any time you test new waters, risks lurk beneath those waters, the biggest one being failure. However, the upside of innovation is great, and there are many valuable lessons to be learned even in failure.
Ultimately, today’s innovations are what will become tomorrow’s best practices, but these innovations cannot take place without a willingness to challenge assumptions and entrenched procedures.
Audacious Acts Turned Best Practices
At 18 years old, Andrew Carnegie was hired as a telegraph operator for Thomas Scott, superintendent of the Pennsylvania Railroad Company’s Western division. One day when Carnegie was at work, a wreck occurred on the railroad, causing delays for other trains. Though Carnegie did not have the authority to do so, he boldly wired the message “Burn the cars” to railroad workers.
The act of setting an expensive pieces of machinery ablaze was not exactly considered a best practice by railroad companies at the time. Needless to say, railroad executives were stunned by the fact that some kid with no authority had ordered that their railroad cars be burned.
But after some number crunching, executives determined that Carnegie’s decision was an efficient one, effectively cutting delays and costs. As a result of Carnegie’s audacious act, burning cars soon became the new best practice following wrecks.
Unlike most in the railroad industry, Carnegie considered the possibility that the current best practice following train wrecks might be wrong. Railroad executives assumed that the act of burning a train would be far more costly and inefficient than fixing it, but as it turns out, they were wrong.
Now I’m not suggesting that anyone do anything as daring as Carnegie, nor should Carnegie’s sometimes questionable ethics be emulated. But the story is both interesting and instructive.
What Do You Think Might Be Wrong?
What do you think we might be wrong about in patient recruitment? What assumptions, visible or largely invisible, deserve reconsideration? What common patient recruitment practices would you like to burn to the ground?
Regardless of whether you come from a sponsor, CRO, site, or patient recruitment company, your perspective is very valuable to others in the industry who are reading this blog. And I know people have opinions on this, so please share them in the comments below.