At first blush, change management seems like an oxymoron. How can one “manage” change? If it’s manageable, your company doesn’t need a department or consultants to handle it. The change we seek to manage is by definition threatening – in its speed, extent, personal impact or uncertainty. How can such a threatening change be managed? In fact it can be, and must be, but not how clinical research sponsors do it now.

Change management has been too often co-opted by human resources departments, IT consultants and senior management as a cover for downsizing, outsourcing or defending politically-driven, illogical reorganizations or force-fed mergers. In this context, the change to be managed is staff acceptance of events that are not in their best personal interest.

Change management is used to underpin broad and thin executive initiatives that produce little more than PowerPoint slides and posters in the hallways. The resulting mistrust and cynicism is deadly when true change management is needed: who is going to listen, or commit, to a project that looks and smells like the one last month that outsourced their colleagues?

In such an environment, the change management activities that are applied are equally superficial. Employing generic process improvement principles and tools, and led by generically-trained facilitators, the workshops and training and newsletters and self-congratulatory celebrations have more in common with political rallies than serious analysis and commitment to improving process efficiency.

What It Should Be

True change management (let’s call it “TCM”) is characterized by a set of values and actions that reflect seriousness of need, long-term commitment, and demonstrable results. As presently staffed and prepared, it is unlikely clinical research sponsors can pursue TCM on their own without some major attitudinal adjustment.

TCM can and should be about, in part:

• Discovering facts
• Disseminating information with clarity
• Speaking the truth
• Asserting clear command
• Simplifying cross-currents and contradictions
• Recognizing and considering self-interest
• Taking small, frequent steps
• Seeking quick proofs of success (i.e., value)
• Sustaining the effort.

Focusing on these values would be an enormous step forward. It is critical that the emphasis not be placed on tools and training – these are essential, but are the means, not the end. Currently, those clinical research sponsors who claim that they are serious about TCM have only the investments in these mechanics to show for it.

Instead, for any time of change, we have to ask:

• What do we keep
• What do we throw away
• What do we add
• What do we innovate.

It is said that when comparing humans to chimpanzees, 99% of the genome is the same. Quite a difference, that one percent! But the lesson is that change is essentially conservative (i.e., conserving), and therefore should be less scary and more embraced.

It may be useful to think of TCM in Stages familiar to a pharmaceutical enterprise: Discovery, Diagnosis, Therapy and Maintenance. Much as in drug development, TCM cannot be complete without all Stages being covered. It seems that we are always in a hurry when there is a problem, and we jump to the Therapy Stage, skipping all others. When we think we have no problems, why bother with any TCM at all? This is a bit like saying we do not have to do anything for our health until after the first heart attack. The best time to begin the Stages of TCM is now, regardless of your perceived state of health. And all of the Stages are necessary – you have to analyze what you have discovered rather than jump to assumed therapies; you have to maintain the therapy after the initial enthusiasm or fear energized you.

Whatever the right term is – TCM or otherwise – the old “change management” is not leading us to demonstrable solutions to real research operations problems. Rather than using change management as window dressing, we need to institutionalize it as a permanent and sincere effort to better use our resources for the important work we do.