“Consequences are good for us – they are the guides to behavior and decision-making.”

We are not hearing the truth. And we are not in danger of the consequences of the truth. This is not only a poor standard for human interaction. It is directly responsible for inefficiency and perpetuation of substandard performance in clinical development.

How many of us have dutifully filled out “RACI” charts, documenting who is responsible and accountable for various tasks or projects in the clinical development process? Having completed these charts, what happens next? Is our behavior, or the behavior of colleagues, materially changed? What level of concern do we carry when we have been assigned accountability? What are the consequences to us personally for not being successful in a task we are accountable for? Or for that matter, what are the consequences for succeeding in a task we are accountable for? I suggest that in most biopharmaceutical companies, where the projects are so large and interdepartmentally dependent, there are essentially no consequences of our actions, good or bad, in any manner that significantly guides behavior. In fact, what does guide our behavior, in a damaging way, is this fact that there are no consequences one way or another.

Developmental Immunity

What happens if we fail at our work? If we don’t lock a database on time, we miss a monitoring visit, we let our CRO go over budget, we obstruct process improvement, or – universally – we miss our enrollment dates? Do we lose our job? Our rank? Our stock options? Do we even lose our credibility? It is not at all clear that anything adverse occurs. In a very few urgent, high-stakes circumstances, the consequences may indeed be onerous. But mostly we live on, more or less unsanctioned, for as long as we care to hold on to our jobs.

What happens if we do a great job? If we bring a project in on time or under budget, keep the CRO from changing project managers, enthusiastically contribute to process improvement, write reports with no corrections needed, or – amazingly – meet the enrollment targets? Do we get promoted, get a raise, get more stock options? We hope our credibility improves. In the rare entrepreneurial biopharma environment, there may be a financial benefit. But in an environment where pay raise percentages are severely limited by policy, where cost-cutting is shrinking supervisor discretion, and where special recognition is culturally disapproved, the good news will go unrecognized. Mostly we live on, more or less unrewarded, for as long as we care to hold on to our jobs.

We do a better job raising our children than managing our companies. Good parents teach their children the consequences of their behavior, either overtly or subtly, every day. Morality, socialization, even just getting through the day, would not be possible without the concept of actions and consequences. Indeed, we probably learn more about life from the application of consequences than we do from the classroom. In the absence of consequences, we get widespread mediocrity.

In all of these ways, consequences are good for us – they are the guides to behavior and decision-making. Economic markets are ruthless appliers of consequence. If nobody needs or wants our new drug, no one will pay for it. If we can’t hire people because our salaries are too low, we can’t get out work done. If we consistently mistreat our CRO with unreasonable demands or poor communication, they will give us inattentive service in return. These are the consequences that teach us how to succeed as people and businesses. So why don’t they apply internally?

Risk, Rewards, Fear, Teams, Truth

There are at least five consequences of the lack of consequences:

· The absence of truth

· Irrational fear of truth-telling, and consequences

· Dilution of the value of rewards

· Hiding individual accountability behind teams

· An unhealthy absence of risk.

What does truth have to do with this? Telling the truth should have consequences – good ones. Too often we are afraid of bad consequences, and so routinely withhold the truth, thus depriving us of the good consequences of the truth as well. For instance, if we are afraid to say that a manager is not performing well, then all sorts of bad things happen: that manager does not learn she needs to improve, her staff continues to suffer, the work continues to suffer, improvement is blocked, staff cynicism grows. But most supervisors are more afraid of telling someone they need to improve or else. It’s the “or else” – the consequences – that must be at the heart of the performance feedback. Otherwise we’re back to stagnating in mediocrity.

There is good reason to think that this situation will get worse over time. It has been widely observed that we are raising a generation (at least in the US) without consequences – where everyone gets a trophy in every competition, and it is culturally incorrect to admonish poor performance. Presumably there will be a rude awakening – in college, or on the job. But what if corporate environments imitate the youth culture as this generation becomes the management layer?

Perhaps the best cover given to poor performance in most clinical development groups is the reliance on teams. I’ve written this before and it can’t be said enough: teams cannot be held accountable for anything. Only individuals can. While I suppose it is possible to demote or fire a team, it is highly unlikely. Team accountability makes the application of consequences almost impossible. You can give everyone a t-shirt if the team succeeds; can you take the shirt off their back when they miss the deadline?

A powerful fairytale for our fearful, politically-correct corporate cultures is the Emperor’s New Clothes. Clinical development groups are filled with courtiers afraid to point out that the manager next door, or their team leader, is naked. Trying to articulate and enforce consequences is risky. What if staff get offended and leave? What if they resent one person being rewarded but not them? Will you keep your job if you reveal the emperor has no clothes? Will you open your company to lawsuits if you tell an employee the truth about their poor performance?

We have to create clinical research environments where it is safe to be a truth-teller about process performance, or we will never improve our productivity. We have to know there will be consequences, fairly and quickly applied, for all of our actions. Truth, and consequences. In the fairytale, it is the little boy who has the courage to tell the truth. We need him now, at a company near you.