The cost of dysfunctional relationships is very high in time, money, reduced motivation, and reduced productivity.

This column marks the beginning of a new series of essays for the ACRP Monitor entitled “Operating Assumptions.” Its focus will be on the process of clinical research – the good and the less good, the way things are and the way they should be. We will range over the broad spectrum of clinical research conduct and look at the operational challenges – tactical and strategic – that we will be facing in the coming decade.

As the title indicates, we will be targeting “assumptions,” the sacred cows of operational conduct. One such bovine is the common phrase, “it’s not personal, it’s just business,” a phrase used most often to be mean exactly the opposite (not unlike another classic, “with all due respect,” when no respect is being paid at all). Clinical operations success is all about the personal, but our skills in this arena, and our willingness to engage in interpersonal challenges, are limited.

It is Personal

Coping with the personal side of business is a daily task and the source of universal frustration. What is key to recognize is that dysfunctional people create dysfunctional processes. An analysis of poorly performing clinical research groups usually reveals an illogical or flawed process that has its roots in an accommodation to a dysfunctional key player, or flawed leadership, or fatal compromises designed to avoid political conflict.

When we say “it’s not personal,” we are trying to push away this most difficult part of our work, and we are trying to pretend, or hope, that somehow de-personalizing the process makes it “just business,” by which we mean that somehow personalities will be replaced by virtual machines. This example of wishful thinking is rarely satisfied.

Actually, it’s all personal. Let’s think about a not-so-exaggerated workday for a Clinical Project Manager. When she opens up her email in the morning she finds a hundred new email messages. Her study’s CRO project manager has changed again and she learns she has to provide an orientation to the new guy as soon as possible. Her boss returns an email she wrote yesterday, saying she is complaining too much and she should fix her problems with her CRO by speaking directly with them. QA is writing to point out how one of her studies is not following SOPs. Contracting wants her to switch CROs on her program for the next trial because they have negotiated a better deal. Program management wants her to revise next Quarter’s spend estimates.

She checks her calendar and sees that the department admin has her triple-booked all day. She looks up from her desk and some management consultant is waiting at her door for an interview she is already late for, but does not know why it is scheduled.

She goes to her first meeting of the day, a study team meeting. The clinical data manager wants to revisit the edit checks agreed to last week. The statistician is objecting to one of the eCRF designs, even though FPI is only 4 weeks away. The clinical supplies representative hasn’t been coming to these meetings until today, and now announces they can’t possibly have study drug in time. The in-house CRA, who works for her, reports that she’s been too busy and the TMF isn’t up-to-date. Her Blackberry is filling up with new emails and it’s only 9:30.

Not such a farfetched scenario, and most will say that this is just the reality of clinical research operations. But what may be behind this acid-churning hour of work? All kinds of pathologies.

Pathology is Personal

There are several common personal pathologies in clinical research organizations:

Passive-aggressive behavior. Does any of this definition sound familiar?: “Passive–aggressive behavior, is passive, sometimes obstructionist resistance to following through with expectations … marked by a pervasive pattern of negative attitudes and passive, usually disavowed resistance …It can manifest itself as learned helplessness, procrastination, stubbornness, resentment, sullenness, or deliberate/repeated failure to accomplish requested tasks for which one is (often explicitly) responsible…”

Avoidance of confrontation. For various reasons (discomfort, fear of reprimand or reprisal, corporate cultural taboo), we dance around what we want to say and never quite get the topic on the table, thus ensuring the dysfunction will occur again.

Pressure, fear, intimidation. Intertwined with the pathologies above is the pressure to perform with fewer resources, meet the trial timelines or the regulatory deliverables, and keep one eye always on regulatory compliance. The fear means we are afraid to sanction dysfunctional behavior and afraid to fire people who are damaging to the group environment. Many research managers say “it’s impossible to fire anyone around here.” Ironically, the fear factor also means we are afraid to be more inquisitive during the hiring process, which could help us avoid the dysfunction before it starts.

Conflicting agendas. If left without vocal and consistent executive leadership, various groups will pursue individual vertical goals or philosophies that clash with those of other groups. For instance, data management may assume it is the sole entity responsible for data cleaning, while statistics, CQA and drug safety may also feel equally, or more, responsible.

Obscurity and opacity. Each discipline in clinical research preserves its value and job security by speaking in its own professional language, jargon, and unnecessary detail. This enables internal and external staff to shield problems, underperformance or conflicting agendas from those who might object. It is particularly frustrating when all parties are sincerely trying to cooperate, but have lost the ability to communicate with one another.

Incompetence. I can feel readers cringe as they read that word – it is so politically incorrect. But what do we all talk about half the time? Incompetent leadership, incompetent service providers, incompetent staff, incompetent sister departments. Sometimes it’s true – they really are incompetent. And if you can’t fire them (see above)….well, talk about dysfunction!

These pathologies are ubiquitous in research organizations and yet the typical clinical operations manager or employee is not equipped with the training to recognize and improve on interpersonal dysfunction, nor do we commonly work in cultures that protect and nourish interpersonal effectiveness.

Essentially it’s willy-nilly: the people we work with like us or not, have another agenda or not, respect our authority or not. And thus our interpersonal success seems like the luck of the draw – a good boss or a bad boss, a good employee or a bad one. But leaving it to chance is very risky. The cost of dysfunctional relationships is very high in time, money, reduced motivation, and reduced productivity.

Have a Better Day

How do we fix this clinical project manager’s day? Any improvement will be a step forward, so it can be taken in pieces – how expectations are set with employees and CROs, how meetings are run (not for getting through the agenda, but for effective decision-making), writing consistency and cooperation into service provider contracts, and more. These steps may seem small, but they can have great impact.

The larger challenge is to improve the company culture. Many clinical research organizations, perhaps because they are science-based but required to be business-like, are passive-aggressive cultures. Other clinical research units, such as some CROs, are run in climates of intimidation. How do we change a culture? Company culture is a rollup of personal attributes, rewarded explicitly or implicitly over time.

Leadership can improve (if not “change”) culture. If you think you have these problems, share this column with your leadership, and start a dialogue. Be frank, which means you have to be prepared for hearing frank things in return. It may not achieve what you are hoping for, but frank dialogue will cut through the Jell-O of animosity, incompetence and obstinacy.

What is wrong with the catchphrase we started with is its false duopoly: clinical research is a business that is manifestly personal. We need to celebrate, learn about, and become expert in both. Our companies need to value, and professionalize, “the business of people” for clinical research to be a cost-effective success.