If pharmaceutical companies have a special Harry Potter-like Defense Against the Dark Arts class for their management team, one of the first techniques they must be learning is the Culture Defense. When confronted with evidence of their reluctance to change, they are apparently taught to point their wands out in front of them and say, “it ain’t me babe, it’s the culture here”. This turns out to be a marvelous, widely applicable spell – the easiest way out of an uncomfortable situation. There’s one problem: we are the culture.

We can’t all be the rebels, can we? If so, how would the “culture” ever form with beliefs different from our own? To claim that company culture is the reason technology innovation fails to take root is to deny your own place in the company you work. Culture doesn’t kill technology, people do.

This common weakness of corporate organizations is particularly obstructive to the introduction of information technology because technology generates so much upheaval, especially in areas of clinical development still untouched, or merely grazed, by the productive use of software. Often standing in the way of that productivity is the Culture Defense.

Let’s look at the following examples of flawed technology employment where “culture” is often blamed as the cause of failure, and let’s ask ourselves if there might be other reasons lurking.

The Ubiquitous Culture Defense

We’re getting lousy data out of a great tool (an expensive enterprise CTMS for instance, or a state-of-the-art Adverse Event System). How does this happen? The old IT acronym, “GIGO” (garbage in, garbage out), applies. But why is it happening? Why are staff waiting until the last minute to enter trial status information that is supposed to feeding a highly accurate real-time CTMS? Or in the case of the AES, why are antique paper-based dataflows being maintained, while the AES is an alien, unwelcome layer imposed on top. Why is this allowed to happen?

The Culture Defense says, “well, we’re not used to reporting data in real-time”, or “we want to review and double-check the information before anyone sees it”. Or in the safety case, “we won’t risk the importance of safety surveillance to software which may not work”. It’s a culture thing. Really?

Another example: we throw resources (human and monetary) at database lock of our pivotal trial, with no restraint. At that moment there is nothing more important to the company. Our EDC tool, or indeed even our trustworthy old CDMS, might be able to contribute to this moment in timesavings ways, but we don’t take the time to learn how, or change our process accordingly. “It’s the culture.” Perhaps it is, but is that a good thing? Does the Culture Defense make all other options moot?

Yet another: “we don’t measure” here. It’s our culture not to measure, or if we do, we don’t do it consistently, or with rigor, or learn from the results. There’s technology to help us (and if we are using technology at all, we will need metrics to justify its expense some day), but it’s not in the culture. Is that culture or laziness? Culture or fear?

And another: despite EDC’s inherent purpose in catching errors at the site at time of entry, and drastically reducing data cleaning at the backend, many sponsors still insist on multiple layers of data review (data managers, in-house CRAs, medical reviewers, and back to the data managers again) just like in the paper days. “It’s our culture, we want to get it right.” Wrong.

More pervasively, it is common to see clinical development executives across the industry turn a blind eye to what really happens at the operational level. Executives announce an impassioned commitment to a particular process improvement initiative, often technology-enabled, and tiptoe out of the room – leaving the implementation to middle management. In many companies, without the executive watching your back, there is little incentive for middle managers to execute on the vision. Is this disconnect a culture problem, or a management problem?

It Is You, Babe

If individual study teams or even entire therapeutic areas don’t follow company-wide SOPs (but instead make up their own regulatory-compliant “standards”), is that culture, or the acts of individual managers? (It may be a justifiable action on the manager’s part, but that’s logic, not culture, at the source.)

If we put training of the new EDC tool in an e-learning environment, but I (and most of my fellow monitors) don’t really pay attention (we click through it and get “certified” but don’t remember much), can I blame my culture for being anti-training? I’m the one who chose not to pay attention.

If we rely on individuals’ cooperation in using technology appropriately, and people fail to do so, isn’t that a series of individual decisions? If I fail to fill out all the fields in a templated Site Visit Report in my CTMS, isn’t that my choice? The culture didn’t make me do it, I chose not to do it.

The damaging side-effects of the Culture Defense are legion: it enables us to drag our feet when it comes to changing the way we are used to working; it gives us permission to abdicate responsibility without penalty; it enables us to stand in the way of progress with impunity for whatever our personal motivation may be (we’re overworked, we’re jealous, we want our pet project to get all the attention, we’re afraid of learning too much software).

Psychologists will tell us that the most powerful realization victims of damaging habits can have is that they have a choice. The Culture Defense is designed to prevent choice, to prevent individual responsibility, even to preclude individual initiative. The Culture Defense is defeated by individuals choosing not to go along with the easy path, to see the executive direction as good for themselves as well as the company, to embrace change as the inevitable condition of modern business, to risk using tools that may reveal true operating conditions quicker because it is better to do so, to risk measuring because objective data about how we work can make us better workers.

We as individual pharmaceutical company staff, middle managers, and executives, can choose to act in manner that enables information technology to flourish. We can face down the Culture Defense so that our CTMS’s actually produce accurate, actionable data on clinical trial program performance. So that our Adverse Event System is allowed to automate the fatally flawed reliance of paper. So that our EDC tool can be authored quickly, and used by monitors to catch errors and underperforming sites quickly. So that our technology investments are worth the effort.

Walt Kelly, in his famous cartoon strip Pogo, memorably exclaimed, “we have met the enemy and he is us.” Culture isn’t the enemy, we are. Facing up to this fundamental truth will begin to enable technology innovation to meet our expectations.