My Fiefdom, Right or Wrong

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Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2003,

Interdepartmental politics can suffer from competition and mistrust, but for clinical trials to be truly efficient these obstacles need to be replaced by respect and purpose.

Most pharmaceutical executives, if asked, would say that their companies work very well across individual functions, I imagine. They would say that no one can develop drugs without thorough cooperation throughout the discovery and development process. After all, they would ask, we have all these interdepartmental teams, dont we?

Indeed they do have those teams, but a team doesnt create respect, trust, efficiency, or productivity by itself. And standing in the way of cross-functional nimbleness are the kings and queens of the pharmaceutical fiefdoms and their loyal subjects. Too often, its my good over the greater good. Its my fiefdom, right or wrong.

While all sponsors eventually get out good therapeutic products, the industry remains plagued by chronic inefficiencies. Clinical development has many sources of inefficiency, and one of them is the failure of the diverse professions involved in clinical research to work together productively on a consistent basis. Certainly there are particular projects, or particular leaders, or particular moments, in which people do get along well. But these are moments, and do not represent standard practice.

This land is my land
Most interdepartmental activities (project teams, process change projects, technology implementations, acquisition teams) show little tolerance for pressure, unexpected events, disagreements, or changes in management direction (in other words, life). We see teams, carefully constructed with the best of intentions, all too frequently dissolve into recrimination, passive-aggressive withholding, and hallway politicking when the going gets tough.

And this isnt just about teams. It is about the very organizational structure of clinical development itself. Obviously clinical development needs physicians, clinical operations staff, CRAs, data managers, software programmers, statisticians, and medical writers. What we dont need is for each group to place its allegiance first to their department, second to their profession, and last to the company trying to improve human health.

Then you have one of the common methods of process adaptation in vogue today: the creation of roles, as distinct from jobsessentially a superset of responsibilities assigned to higher performing individuals without any increase in compensation or diminution of their original responsibilities. By proliferating roles without letting go of profession-based structures, you have double the bureaucracy and double the pressure without really making an improvement.

Organizing for failure
Organization charts are the language of a company. A company speaks through these documents. It tells us what is important to them and what is not important, what it values, and how well it understands itself. Too often we see companies organizing for failure. The first clue comes when you ask for the organization chart and are told that human resources wont let you see it. We know of several companies where managers cant even see the organization chart of their own department. If this is the case, you know the company language has lost its tongue.

What are common ways that companies organize for failure? Organizing to protect egos is organizing for failure. Organizing to prop up someones headcount to justify their title is organizing for failure. If you cannot achieve at least logical intimacy among functions, much less true interconnectedness, then you are organizing for failure. If you organize around visionaries instead of managers, you are organizing for failure. But one of the most dangerous trends in pharmaceutical companies today is organizational fragmentation.

This village is my village
Warring fiefdoms is one thing. War within the fiefdom is much worse. There is a growing tendency at some pharma companies to respond to process problems by further fragmenting their organization chart into smaller and smaller pieces. The thinking is that professional specialization will somehow inspire higher performance (ironic, at a time when CRA specialization by therapeutic area is nearly universally rejected in favor of regionally based generalists).

Examples of fragmentation in clinical departments are moves like:

  • organizing support functions into their own department.
  • breaking up the monitoring function into several specialized jobs.
  • breaking up clinical data management into micro-constituencies (programmers, database managers, data managers, data analysts).

The worst symptom of fragmentation is when the pieces are sprinkled hither and yon in odd ways organizationally.

Fragmentation is so damaging, because when you create a micro-profession you compound the essential problem we are describingthe creation of tribes who define themselves by who they are not. The more tribal we are, the more distrustful and disrespectful we are, by human nature.

Worse yet, each new fragment (say, clinical site document specialists) has to create its own department. And what does that mean? It has to have its own meetings, its own representative on the interdepartmental team, and its own career path and job ladder. The micro-profession becomes self-fulfilling and self-perpetuating. A tactic designed to innovate roles ends up instead creating yet another principality, with full regalia. In sum, instead of a source of efficiency, it is a cost-generating machine.

This fiefdom is our land
This is not meant as a polemic against organizational innovation. Rather, I encourage companies to examine their initiatives in terms of their output. Are objective measures of performance improving? Can managers and workers alike say there is less finger-pointing and more respect?

One method of organizational innovation that breaches borders is to lead with focus. Ask yourself, what is one thing (or two things) which our company most needs the organization (clinical development as a whole) to accomplish in the next two years? Figure that out and organize around those objectives, not around disciplines or roles. If the job of clinical development is to get this drug (or three drugs) to submission, then thats what you need to focus on. If clinical development needs to develop this one drug for sure, and needs to change its processes to electronic trials, then those are the two things you should focus on. Nothing else. Organize around these projects and dont chicken out.

Ongoing professional development can always be fed by the many ample means of professional education and communication which exist for every discipline. You dont need to re-create that in your company; organize around what you are trying to do, not who you are.

If people are organized around a sense of purpose, and only so, you are likely to see much greater success because people need to learn to trust and respect each other in order for the work to get done. Imagine if Major League Baseball was organized by position: all the second basemen in one department, the catchers in another, the third base coaches in another. And each day they were asked to come together as a team and win a ballgame. Thats what we try to do every day of the year.

Aretha Franklin was the Queen of Soul. The keys to her kingdom were R-E-S-P-E-C-T. If we all follow Arethas way, avoiding mistrust and fragmentation, then maybe all of clinical development can be one productive land, and even a nice place to work, combining professional and corporate success.