The Woodsman?s Tale

February 1, 2003
Ronald S. Waife

Ronald S. Waife, MPH, is president of Waife & Associates Inc.

Applied Clinical Trials

It may seem impossible to do what we know is right?to try to save time and money by spending time and money.

When railroads were first being laid across the country, the woodsmen who felled the trees to make way for the tracks were heroes. A tale was told of one particular woodsman of Bunyanesque achievements who mowed down trees at a terrific rate. After some weeks of this furious effort, news filtered back to the crew chief that the heroic woodsman had slowed down considerably. Worried, the crew chief rode out on his horse to find the logger. He discovered the man (lets call him Paul), on his knees, shirt off, sweat flying, flailing away at a particularly large tree trunkmaking no headway at all. The boss asked Paul to stop for a moment and show him his axe. When the boss felt the edge of the blade, it was as dull as a butter knife. Paul, the boss said. No wonder youre exhausted and getting nowhere. Youve got to stop and sharpen this blade. Paul looked at the trees that stood in the path before him and scoffed, I cant stop, I have too much work to do!

The lesson to be learned from this tale is one sorely needed by clinical research departments all across our industry. Be it in clinical monitoring, medical affairs, data management, or wherever processes need improvement, the universal cry is, I cant stop, I have too much work to do!

The examples are plentiful. We urgently push ahead with dull-bladed processes for protocol approval, edit check development, investigator evaluation, subject recruitment, site monitoring visits, adverse event tracking, data queries, subject-generated diaries, investigator payments, project management, and program decision making. We push ahead, knowing we could do better, knowing we need to stop and sharpen the blade, knowing we are falling farther behind. We get caught in the fallacy that we are too busyor cannot afford to allocate the fundingto stop and do it better. How can we? We have trials to do!

I cant afford to save money
Lets look at some real-life examples. The circumstances have been changed a bit to protect the guilty. A small biopharmaceutical company has a lead compound in an esoteric therapeutic area, and its pivotal Phase 3 trial will require a large number of hard-to-find subjects. Subject recruitment companies submit various proposals to meet the challenge, all of which are very expensive and use timelines that are much too long. The clinical director suggests using well-informed colleagues outside the company to call every known possible site and prequalify them for subject eligibility. The clinical directors colleagues say they can do it in less than a month. The vice president rejects the idea because it would cost too much, and tells the already overworked clinical director to make the calls herself, which to him means, It wont cost anything to do it ourselves.

The result? It takes the companys own clinical staff months to reach about half the sites, and the information they get is not encouraging. Meanwhile, the trial is already underwayin order to keep the trials going and to satisfy investorsand recruitment is poor. In addition, the clinical director has been fatally distracted from her many other duties critical to the companys broader program.

If the company had instead spent the money up front on the 30-day calling program, the management team would have found out before having to start the trial that prospects for recruitment were dismal and another study design should be found. Obviously, starting up the study without sufficient information on available subjects was many times more expensive than what the calling project would have been. Penny-wise, pound-foolish, or as we say, I cant afford to save money.

We can cite many other examples that will be familiar to the reader. Companies that spend millions on new software applications, without paying what may amount to less than 20% of the purchase price to implement a project for properly changing the work processes to fit the new software. Or changing the process of data cleaning (say, backing off from 100% source data verification) but not paying for training the monitors in the why and how. Or buying generic SOPs that end up being thrown away, or which need so much revision it would have been cheaper to have someone write new ones from scratch. And so on.

I dont have time to save time
Lets look at another example. A clinical operations department has ample evidence that its processes are confused and inefficient. Regional monitors report that different home office project managers manage their projects differently. Relations with clinical data management are strained. In-house clinical research associates (CRAs) are complaining about the field CRAs, and vice versa. Roles and responsibilities have become fragmented and inconsistent. Realizing her department is a mess, the clinical operations director calls in a consultant to discuss remedies. The solutions sound great to her. But sorry, she says. We dont have time for them. The director goes on: I can only yank the regional monitors out of the field once a year (theyre too busy otherwise), so I can give you two hours on Tuesday at the annual meeting. Is that enough time?

What about the process mapping exercise for the home office departments to figure out how to work better together? the consultant asks.

Oh no, that takes up way too much time, and we couldnt possibly get everybodys schedules to line up together.

It took a hundred people and 10 years to make their operational process work this badly. Can we seriously expect that two hours on Tuesday will fix it? They know they have the problem, but they dont have the time to stop and sharpen the blade. Or as we say, I dont have time to save time.

Stories like these can be found in every company. It is always difficult to interrupt everyday work, work that is critical and overextended, and ask people to essentially work on something elseto work on making things better. It may seem impossible to do what we know is rightto try and save time and money by spending time and money. Without doing so, we end up like Paul the woodsman, down on our knees, flailing away at a massive tree trunk with our dull-edged axe. The ease with which your tasks proceed as you wield a finely honed axe will more than make up for the time and money you spent on sharpening the blade.