You're Trumped!

June 1, 2004
Ronald S. Waife

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

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2004,

In contract research and contract bridge, the cards aren't as important as the people holding them.

In contract research and contract bridge, the cards aren't as important as the people holding them.


If clinical trials were a bridge game, the rules would be very interesting. Bidding would have to be completed before the cards were dealt (since the protocol is always late). Your partner would always be working against you. And you would be thinking that the only one who isn't the dummy is yourself! Among the four suits (science, process, technology, people), when it comes to winning hands, we do know one thing about this game: process trumps technology, but people trump process.

People vs. processMany times when we talk about process problems, we're really talking about people. And while the two seem inseparable, companies are more willing to confront process problems in the abstract rather than people problems in the specific. This can frustrate the considerable time and effort companies will invest in process improvement.

People problems show up in myriad ways: people who resist change because of fear of the unknown, or comfort with the familiar; people stuck in inertia; people who simply demonstrate a lack of energy or motivation. People get in the way for sincere and positive reasons also: they are too close to the details to see the bigger picture, or they are too busy to stop and help implement change.

Often in biopharmaceutical companies, we see people selected to lead or help participate in catalyzing change who have no previous experience with such a situation. As a result, they can neither recognize nor overcome these issues of resistance, fear, inertia or passivity. As younger people move in to entry-level positions and new managers move in above them, what are you doing to develop their skills and sophistication, at both levels?

Culture as co-conspirator
Every company has a culture-its beliefs, customs, practices, and social behavior-which, if plagued by some of the common afflictions below, contributes to people trumping process. Do these phrases or practices sound familiar?

  • Everyone is equal (but they aren't, anymore than everyone is above average in Lake Wobegon)
  • Consensus decision-making (a contradiction in terms)
  • Work smarter, not harder (but people aren't given the tools or developmental training to do so)
  • Management by objectives (and yet everyone gets the same salary raise)
  • Be creative, show some initiative (but no one follows the risk-taker's lead)
  • The satisfaction of a job well done (translation: we don't have the money for anybody's raises this year).

Each of these corporate mantras is a means of seeking to control the people variable. Well-meaning or not, they rarely succeed for more than a few months, if at all. And this directly impacts process improvement initiatives, since the failure of these creeds creates skepticism, takes up staff time better spent on real improvement, and displaces the taking of responsibility.

You can't fire a process
You can't hold a process accountable for failing to meet an objective. You can't give a process the authority to make decisions and spend or withhold dollars. Only people can be made responsible for process improvement. But while we spend many months analyzing processes in detail, building robust maps of micro-specificity, and enthusiastically write "to-be" SOPs for reformed processes, we are not spending an equivalent amount of time and effort on the people who will need to implement the process change-neither the selection of processes or their development.

Winning the hand
How can we avoid the problems described here? There are several important steps that management can take:

Recognize that people make process. This doesn't mean you should only focus on generic and vague staff development, a common corporate failing, but rather you need to maintain a clear focus on your company's business objectives for the year and identify the gaps in your people's skills and motivation to achieve these objectives.

Spend time with people. If you are attempting process change or improvement, you must accept that regular work schedules or output cannot be maintained in the same period of time. You must schedule time for training and development and specifically budget more dollars for courses and travel during these process change periods if you expect to see fundamental improvement.

Be tough with people. Slowly but surely, competitive pressures will change the landscape for biopharmaceutical companies large and small. There will be a time when biopharmas can't take the 20-year developmental view with their employees (small biotechs and CROs already know this). This means you must be demanding of your staff, while always being fair in the resources you provide them to succeed. And it means that your expectations for employee performance must go well beyond their scientific contribution, whether they are on time for meetings, or whether they play well with others.

Recognize creativity. There is surprisingly little creativity in the everyday work at biopharmas. Upper management must sincerely request and recognize creativity from their staff, and place a clear, well-communicated value on creative approaches to work process through visible recognition programs.

Provide meaningful monetary rewards. It is not disparaging to say that people respond most to financial incentives. While many surveys indicate that employees want recognition, appreciation, and opportunity to make an impact more than financial rewards, when it comes to making people replace the familiar with the new and participating in time-consuming, risky tasks to effect change in daily work, there must be something in it for them besides a t-shirt or a Lucite paperweight. If you are selling your staff on the idea that all this process improvement is going to improve the bottom line, you need to share those profits with the ones making it happen.

People will win or lose the hand for you, and yet we don't spend enough time on choosing, developing, and watching over the players we have. In the bridge game of clinical trials, don't let your staff trump you. You'll need all your cards to compete successfully.

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