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Finding Efficiency in Clinical Research

It Ain’t Me Babe, It’s My Culture (Clinical Researcher, February 2017)

If pharmaceutical companies have a special Harry Potter “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, 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 that operational innovation fails to take root is to deny your own place in the company you work. Culture doesn’t kill efficiency, 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 process improvement 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 clinical trials monitoring service [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 our staff waiting until the last minute to enter trial status information that is supposed to be feeding a highly accurate real-time CTMS? Or in the case of the adverse events system (AES), why are antique paper-based data flows 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: A major process improvement project is organized into the ubiquitous “workstreams” and comes up with a flood of recommended changes. Several of the most important changes require re-organizing staff, and while the net headcount will stay the same, some people will probably not fit the new skills required. Impossible! Why? Because “we don’t (or can’t) fire people here – it’s our culture.”

And another example: We throw resources (human and monetary) at the database lock of our pivotal trial, with no restraint. At that moment, there is nothing more important to the company. If the data management processes are examined, however, you will likely find that the electronic data capture (EDC) tools you have used for years are being used sub-optimally and inefficiently. It’s the culture. Perhaps it is, but is that a good thing? Does the Culture Defense make all other options moot?

Yet another example: “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 probably loads of data – indeed too much data – for you to measure from, but it’s not in the culture to act on this information. Is that culture or laziness or fear?

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, 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 CTMS tool in an e-learning environment (although most monitors won’t really pay attention and only click through it to get certified), can we blame our culture for being anti-training? It’s the individual who chose not to pay attention. If we rely on individuals’ cooperation in using new tools 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 template-based site visit report in my clinical trial management system (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 (e.g., we’re overworked, we’re jealous, we want our pet project to get all the attention, we’re afraid of learning too many new process details).

Psychologists will tell us that the most powerful realization victims of damaging habits can have is that they have a choice to change. The Culture Defense is designed to prevent choice, to prevent individual responsibility, even to preclude individual initiative. The Culture Defense is defeated by individuals who choose 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 getting information that may reveal true operating conditions quicker because it is better to do so, and 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 a manner that enables operational improvement to flourish. We can face down the Culture Defense so that our process redesigns are easily learned and pragmatic, so that our CTMS systems actually produce accurate, actionable data on clinical trial program performance, so that our CRO vendors are well managed; so that our technology investments are worth the effort to implement them; and so that our diverse and broadly skilled staff can be focused on productive work with urgency.


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 operational innovation to meet our expectations.

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