Sometimes, when the resistance is greatest, the treasure being guarded is the most valuable.
“The path of least resistance” is a seductive phrase. It is used so often by those made nervous by change, or those who simply want to avoid conflict. It is seductive because it sounds wise, mature, even efficient. And sometimes I suppose it is. But often as not, the path of least resistance is very winding, indirect by definition, filled with backtracks, detours and roundabouts. It may have the least resistance, but sometimes it is the slowest path, without any guarantee that you won’t come to a dead end.
Boulders Aplenty
The path we take to arrive at change – in a process or strategy or the tools we use – is a key determinant of success. The resistance that we usually seek to avoid can take innumerable forms, and so these seem like daunting boulders in our way. Let’s list just a few:
§ Inertia, the immutable law that states that an employee entrenched tends to stay entrenched
§ Lack of a perceived demand for change, or “what’s everyone so upset about?”
§ Distractions, as in “I’m too busy figuring out how the latest merger affects my retirement plan”
§ Alternative priorities (“I have my own agenda, thanks very much”)
§ Compliance, as in “I’m not sure which one, but I’m sure the regs don’t allow that”
§ We have a process for that, where “process” means bureaucracy
§ We have channels for that, as in “go see the contracts office”
§ Personalities (take your pick, from passive or hostile to know-it-all)
§ And the ultimate boulder, the budget (“sorry, we didn’t budget for that this decade”).
When faced with this landscape, no wonder we typically look for less resistance, but if we try to miss all the boulders, how will we ever find our way?
Examples Aplenty
Throughout clinical development there are many boulder-strewn pathways to greater efficiency. Let’s think about just two examples: reducing source data verification (SDV) and improving protocol feasibility. First let’s look at the paths of least resistance.
SDV is a sacred cow milked by data management, monitoring, statistics and QA. And time-and-materials-based CROs endorse the labor-intensive policy wholeheartedly. The path of least resistance will lead us past these pools of quicksand on a route that nods empathetically to each of the resistant constituencies. We will concede that once you start looking at one field on the eCRF, you might as well look at them all. We will let statistics throw more queries on the truck. We won’t try fighting QA’s fears by taking the time to read the regulations more carefully. And we will give in when the CROs warn how expensive it will be if they have to change their SOPs just for us. The path of least resistance will lead us to a minor reduction in SDV, with virtually no efficiency benefit, but lots of arguments avoided.
With improving protocol feasibility as our destination, the path of least resistance will take a very wide turn around the medical affairs staff who just joined industry from academia yesterday, abdicating our responsibilities as clinical operations professionals. We will go miles out of our way to accommodate key opinion leaders essential to research paper authorship, but out of touch with patient populations and their health behaviors. And we will take the superhighway to the advertising agencies who will “rescue” our study after infeasible enrollment targets are missed.
There’s Gold in Them Thar Resistances
We cannot base our work on the paths of least resistance. Of course we want to work without acrimony, arguments, and escalations. But our industry is suffering from this ingrained fear. Complacency and inertia have led to a degree of ineffectualness that triggers executive dismissal of the clinical development function. So far, that means simply transposing the inefficiency from internal resources to external ones. A better analysis would recognize that sometimes, when the resistance is greatest, the treasure being guarded is the most valuable.
Facing the resistance should not be corporate suicide; instead it can take the lid off of hidden misunderstandings and past grudges. For instance, challenging traditional SDV policies head-on, if done correctly, generates a healthy debate that puts the issue in the context of modern realities instead of 1990’s assumptions. Similarly, maintaining weak protocol evaluation practices to protect interpersonal scientific relationships will only cost us time and money we do not have. A direct comparison of expert opinion with properly collected data on patient populations, distribution and attitudes can have a lasting improvement on clinical development performance.
If we can get past entrenched self-interests defending the current SDV policy, by confronting the boulders head on, we will discover remarkable reductions in necessary data monitoring effort. If we face the rock cliff of infeasible protocol designs at the first gate, and dare to say that climbing it is more important than ego, then we may find a much shorter path to full enrollment on the other side.
The path of most resistance may be arduous at first, but as with all pathfinding, the more we travel it, the smoother and faster the path will become.