“Fixing operational problems in clinical research, regardless of their cause, will usually end up requiring a discussion that we are trying to avoid.”

We humans are a mostly affiliative species. We like to be in groups, we like to do things together. In order to do things together, we have to get along. We all know how well people get along with each other – of such stories history is made! Corporations are the ultimate business expression of affiliation, and so they are the ultimate environments for people trying to get along. Most operational process problems in clinical research can be traced to people not getting along, for many reasons ­– philosophical, psychological, scientific, interpersonal, uninformed.

Fixing operational problems in clinical research, regardless of their cause, will usually end up requiring a discussion that we are trying to avoid, because of the inherent disagreement in the topic, or personal antipathy, or a power differential. These are difficult conversations to have. We avoid them for a short-term gain in affiliative peace. The long-term cost is a problem left to fester, a reinforcement of unproductive relationships, a solidification of the intimidation of power. In such an environment, true improvement is very hard to achieve.

Conversations Left Unsaid

There are dozens of conversations we should be having during the clinical research process that go unspoken:

§ How do we tell the sponsor physician that the key opinion leader is a lousy recruiter?

§ How do we call the bluff of the manager who says he “welcomes change” but never implements any?

§ How do we get the CEO not to promise a trial start date to Wall Street that is operationally impossible to meet?

§ How do we tell Quality Assurance that their interpretation of the regulations is incorrect?

§ How do we tell an employee, or a peer, that they aren’t good enough at their job?

§ How do we tell the functional director that sending a powerless representative to our meeting in her place is a waste of everyone’s time?

§ How do we tell the data management standards committee that the need for flexibility is more important than blind adherence?

§ How do we tell the boss that the process improvement project is a waste of time because we know she has no budget to implement the recommendations?

§ How do we contribute an honest “360-degree” performance review on our peers without having it backfire?

§ And most fundamentally: how do we call someone out for not doing what they were supposed to do?

I am sure you can supply your own examples. What is happening in each of these cases is that someone is failing to execute their work properly, affecting all of those around her, and yet we enable this failure by being afraid or embarrassed to try and do something about it. It is directly analogous to “enabling” an alcoholic.

Difficult Consequences

Unfortunately, there are very concrete consequences to our avoidance of difficult conversations. Let’s take a complex, real example which at first glance seems unimportant but which has considerable consequences: A study is in startup mode with a clear sequence of events, some of which include: finish the protocol, send it to the various site ethics committees (ECs), build the electronic case report forms (eCRFs) in the meantime, certify the sites’ knowledge of the trial software, distribute study drug, start enrolling. But what if one sponsor physician on the project insists that for marketing or professional reasons, Site “D” must be one of the first enrollers, and that Site is in a country that requires final eCRFs before EC approval. As we know, that interrupts the carefully planned, time-pressured startup sequence. To wait until final eCRFs are ready, and then wait for Site D’s ethics approval, will ruin the study timeline – but the study physician insists and he’s backed by his management.

A difficult conversation is required. The study manager (or worse from a political standpoint, the data manager) has to explain the timeline change and suggest letting Site D start enrolling later. In this example, no one on the operations side felt they could confront clinical affairs with this reality without being punished for not “helping the team” by “taking on the challenge.” Instead the corporate culture expected the operations team to perform their now customary heroics to cope with the site dilemma while preserving the timeline.

The consequences of avoiding the conversation are far-ranging. The study physician feels vindicated and immune from censure. The data manager feels de-motivated by the thought of the perpetual heroics required of her. The study manager quietly seethes and seeks a future opportunity to get revenge. All of these are the seeds of inefficient clinical research.

How We Can Talk

Some may despair at having difficult conversations, and some may shrug. Look at the power differential, look at the interdepartmental antipathy, look at the personalities involved. Shrugging or despair is not enough. The consequences on performance are too dire. While operational accountability has been loose for many years in our industry, this is ending rapidly. Inefficiency will mean your department ends up outsourced and your job (at sponsor or CRO) will be in jeopardy. In the long run it means foregoing clinical programs that may improve our medical care but we cannot afford to complete.

There are a few, challenging ways to have difficult conversations that may get us out of these situations:

§ Be courageous. Simply said and hard to do, but many situations described in clinical research operations can and are defused more easily that we expect – it just takes the courage to start the conversation.

§ Once engaged, depersonalize the situation, especially where the history of antipathy overshadows all. It’s not about what he or she said to you yesterday or last year, or what seems unfair, or what you think your career needs. It’s about the work, the study, the science.

§ Gather and focus on the facts. In all difficult conversations, the facts get lost in the power or the feelings or the legitimate stresses of time and money. Ignore these, and focus on facts that are indisputable and well-articulated.

§ Employ a work process that neutralizes the power differential, and actually makes difficult conversations routine. There are basic process designs that are intended to specifically overcome these difficulties.

§ And do not overlook the need for executive commitment to a culture that is both safe and efficient – safe for staff to challenge each other and those in power, and where staff are sincerely empowered to root out inefficiency.

Lots of things are difficult. Mostly we need to do them anyway. It is the responsibility we inherit to live in the remarkable society humans have created.