You’re Trumped!

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. process Many 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.

Know When to Hold ‘Em, When to Fold ‘Em

Leadership and process are so important to clinical research effectiveness that the stakes are as high as a big-time poker game. Kenny Rogers sang that the key is to “know when to hold ‘em, know when to fold ‘em”. Tricky in poker and tricky in business: when and how do you remove a person from the job they are in, because they are an obstacle to success?

The toughest task an executive faces is to take a talented, well-respected and/or hard-working manager, and reassign him or let her go. It’s so tough, that many executives don’t do it. The most common response to an under-performing or difficult employee is to cover your eyes, cross your fingers and toes, and hope the person leaves or transfers on their own accord. It can be a long wait. And meanwhile, your operation suffers.

Many Reasons, Few Alternatives

The need to remove someone from a key position can have many sources. Some people’s jobs are no longer important to the enterprise, or the job has changed in a way that does not fit the experience or skills of the person in place. Sometimes the position has to be weighed against other needs, and the company simply cannot afford this spot anymore, useful as it may have been.

Sometimes the person has been promoted beyond their abilities (as Laurence J. Peter most famously wrote about in 1969). Often in clinical research organizations, you find managers who are threatened by change, and they resist in a misguided attempt to protect their jobs, when in fact they are ensuring their demise. And this is not just about firing the old-timer by any means – there are plenty of young rising stars promoted beyond their experiential foundation, where a senior person is better suited.

The team approach to so many clinical research processes today raises its own problems. As pointed out in previous columns, often the same small group of best team leaders are asked to serve over and over again, concurrently, on multiple teams. Effectiveness leading team A does not necessarily translate to team B, or the person may burn out, or not recognize that what worked for his last team is the wrong way to lead the new one.

The British have a unique word for letting someone go (“redundancy”) which can actually be quite accurate rather than simply euphemistic. This is particularly true in merger situations – what do you do with two directors of monitoring, or two directors of biostatistics? The tougher task in merger situations is to not protect people in power for the sake of merger politics, but to make the honest evaluation of the entire management pool and decide: who is best for the new company and its new needs?

Holding on to the wrong manager is particularly painful for small companies who cannot afford under-performers, or don’t have a place to hide them. In a small biopharma or service company, everyone is in the spotlight. The company is truly a lean multifunctional enterprise where everyone needs to do her job well, and there is no safety net. Shying away from the tough decision to hire or transfer brings everyone down. As Harvey Mackay observes in his book, Swim with the Sharks without Being Eaten Alive, “It isn’t the people you fire who make your life miserable, it’s the people you don’t.” Since I am enamored with baseball metaphors lately, think of it as leaving the long-time star pitcher in the game an inning too long: it hurts everyone, including him, if you don’t walk out to the mound and take the ball away.

Removing someone from their position can be particularly challenging for organizational cultures that move slowly, or that pride themselves on the proverbial “family atmosphere”. People don’t get fired from their families (much as we wish they could!), and the company perceives the value of the family metaphor to be so beneficial that they will suffer through years of misplaced, under-performing aunts and nephews.

Standing in the Way of Good Research

The relevance of the under-performing manager to clinical research is evident in many ways:

–Times are changing, and processes are changing. Not everyone is up to the task of change management or skilled in the nature of the new process, which may require more personal flexibility, less emphasis on making people feel good, and undoubtedly more technology-based tasks.

–The increasing pace of global development may be too much for someone who is not adept at multicultural management.

–A shift in therapeutic area focus will bring challenges that demand a mind willing to accept and understand how things are different.

–For each maturing generation, with its unique skills and experience, it can be difficult to lead a younger generation which has a subtle but meaningfully different set of values (and vice versa).

–And then there are the superstars who are put in a place of leadership, without the life experience to handle crises, the interpersonal skills to manage teams, or the sensitivity to recognize political or interpersonal subtleties.

Change is Good

In my experience, the most common cause for a failure to fire is fear, and usually this fear is based solely on inexperience with the process, and thus it is a self-perpetuating stalemate. Executives don’t learn how to move someone out of a position, and so remain fearful of it. There is nothing more personal than having to confront this issue, face-to-face, with the employee on the receiving end, and nobody wants to put themselves in that position.

At the risk of sounding like some hated Human Resources guy in a cartoon, management change does not have to mean execution; it can mean a mutually beneficial change. Clinical research organizations have many diverse needs, and experience in research is a valued prize. So the company can often benefit by applying the deposed manager’s abilities elsewhere in a new role, even if she is no longer “in charge” of something.

Of course a humanistic employer has an obligation to do everything it can to ease the transition or exit. The key is the make the decision as soon as all the evidence is in. Talk to your peers, superiors, and the person’s direct reports, but do not be afraid to follow your instinct. This is what you are being paid to do: make judgments. Move swiftly and fairly, and know what you want the next steps to be – where the person can transfer to, or how they can be helped to leave as positively as possible.

An executive we all admired once said wryly to me, as he was being escorted out of the building, “change is good.” A pharma manager recently told of seeing someone in a store some months after she had had to fire him. The man walked up to her and thanked her, for helping him move on to a better situation, “the best thing that ever happened to me.” Of course it doesn’t always have a happy ending, but happy endings is not what being an executive is all about.

Judy Collins sang the words that Sandy Denny wrote: “Ah, but then you know, it’s time for them to go.” May you have the wisdom and courage to recognize it when the time has come.

Learn Before You Leap

Training is a dirty word. In the corporate environment, trainers are relegated near the bottom of the pecking order. Training departments are considered the holding pen for under-performing line staff and has-been managers. Training programs are considered to be an onerous burden on an employee’s schedule. And not surprisingly, when it comes to budgeting for training, it is always last on the list and the first to be cut. When implementing change in the clinical research process, especially when introducing new concepts or technology applications, this attitude is fatal.

Maybe we need a new word for it. Training is boring. Training is passive, repetitious, artificial, divorced from reality. Of course none of these adjectives need be true about the learning process, but too often they are. So let’s call it “learning” for now, and talk about how essential learning is to process improvement.

Process Improvement as Learning

Process improvement itself is essentially a learning process: we learn by analyzing the root causes of delay, dysfunction or inefficiency; we learn by mapping how work actually gets done; we learn from the metrics we use to gauge where we have been and where we are getting to. The phrase “lessons learned” is an essential component of new technology introduction: if your company is piloting new software and you do not formally and proactively document your experiences, from your earliest attempts to use the software, you will simply repeat the mistakes and missteps of those who have gone before you. The more you use the software the more there is to learn, and the more that will be lost if someone isn’t keeping track. As obvious as this is, few companies have a formal process for capturing their experiences. There are well-established procedures for instituting such processes – indeed, you may have colleagues in another area of your company who have done so. It is time to bring this into clinical development.

Being a “learning organization”, or building a “knowledge management system”, are two of the most fashionable phrases in process improvement today. The logic of these concepts applies well to clinical operations, but you need not be intimidated by the textbooks on these subjects into thinking that these concepts are beyond the capability of clinical operations staff to exploit. Instead, let your efforts at learning be reinforced by these fashions.

Last on the List, Last to be Funded

As integral to process improvement, technology adoption, and knowledge management that learning is, the dilemma is that training is rarely budgeted for. No dollars, no learning – at least no formal, proactive and comprehensive learning. This universal lack of funding for training is one of corporate life’s most self-defeating characteristics.

The reasons are so obvious that it is hard to even write about. Which do you think is more efficient? To teach someone how to do a monitoring site visit according to company SOPs, or to let them do a few visits and then explain them to what they did wrong? To teach them the contingency plans for software user problems, or to wait until you realize you aren’t getting the benefits from the software you expected?

And yet, if you put a training line item in your regional monitoring program budget, or your EDC implementation budget, it will always be at the bottom of the spreadsheet and it will always be the first one to go when your boss, or your contracting officer, wants to prove how great at cost-cutting she can be.

Learning through Serendipity

How do we get by as well as we do if training budgets are always cut? We do it through the creativity, conscientiousness and goodwill of our staff. We as corporations learn through serendipity – through the initiative of individuals to mentor their juniors, share information with their peers, record their mistakes and their insights. Think of how much more productive we would all be if this valuable insight was captured and delivered in a conscious and professional process of learning.

What’s the problem with serendipitous learning? Today most process improvement projects, or technology adoption initiatives, are so complex, and line staff are so busy with their everyday work, that the learning required to make these innovations succeed cannot depend on happenstance. You cannot rely on your colleague in the next cubicle to tell you what he learned when he tried to use that CTMS for the first time; you cannot rely on your fellow monitor in the next state to tell you how to avoid getting your expense report kicked back by accounts payable. Literally millions are spent to get to the point where process innovation is designed, or new enabling software is rolled out. To not spend the money to go that last mile of learning is to make a mockery of those investments in innovation.

Training that Works

There are at least two key points about institutional learning which are of high relevance to clinical operations. First and foremost, once is never enough. For busy, expert professionals used to doing work one way (and doing it well), you cannot expect them to absorb the learning required to implement the new process correctly in one sitting. We always recommend a three-part program: an overview of the process or software, during which all one hopes for is that the field is plowed and ready for planting. Next you go over everything again, in more detail, and this time the students will be ready for the seeds to be planted. Finally, you train just-in-time, at the moment when they start using the process or software, and only then will the plant truly blossom.

Second, when it comes to technology adoption in particular, you cannot abdicate the learning process to the software vendor. What needs to be learned in a software implementation situation is one-fifth screen navigation and four-fifths business rules. Business rules are the hundreds of micro decisions that a company needs to make about how you, given your particular organizational chart, staff skills, strengths and weaknesses, monetary and time resources, and so on, will actually use the software. For instance, a CTMS may enable your staff to write a Site Visit Report within the application. How does this fit with your SOPs? What information contained in the SVR is supposed to be communicated to other departments? Can this communication be automated? Should it be? Do you want changes to SVRs to be recorded and auditable? Etc. The vendor cannot decide these things for you – only you can make these choices, and once made, they must be taught.

It’s the Will, not the Way

Some companies pat themselves on the back for “taking care of training” by spending money on an innovative learning technology; “eLearning” is another heavily promoted fashion. There is no question that there are now (and always have been) many techniques of training delivery that can enhance and make learning more efficient (none more powerful than a good teacher, something no technology can replace). But delivery is secondary to the content – indeed, to having content, to making sure that your company does not cut training out of the budget and that you have taken the time and expense to document lessons learned, make the business rule choices, and are ready to devote staff time to learn them.

It is said “those who can, do; those who can’t, teach”. When implementing clinical research improvements, those who don’t learn, won’t succeed; those who do, will. .

Nobody Knows the Costs They’ve Seen

The biopharmaceutical industry spends many millions every year on process improvement, and accompanying reorganizations and software implementations. Rarely are these efforts ever satisfactorily justified. The reason is that nobody can put an accurate price on the problem they are fixing. There is a common phrase among process improvement gurus that “quality is free”. What is meant by that phrase, generally, is that a) it costs no more – and perhaps even less – to do things well as to do things poorly; and b) quality improvement will pay for itself – through elimination of waste and inefficiency, or the acceleration of profit.

This slogan works well when top executives are championing process improvement, or their company is financially well off. It is similar to the pronouncement that “this initiative is strategically important” – the implication being that we can’t justify it in short-term dollars but we can’t afford not to do it. But even in the best of circumstances, there always comes a time when somebody says, “Was all that quality improvement (or consulting, or new software) worth it?” Sadly, virtually no company in clinical research, be it a biopharma sponsor, CRO, investigative site or software vendor, can answer this question correctly.

Why is this true? We cannot tell if something is “worth it” unless there is some measure we can all agree on that is applied to a situation and then evaluated. Usually, people want to calculate this measure quantitatively and not subjectively. This measure needs to be both valid (a legitimate evaluation of the issue at hand) and feasible (something that data can be collected about in a practical, cost-effective manner). And more often than not, the measures most important to business are denominated in dollars. Which brings us to cost. If we are evaluating dollars, we are usually trying to prove or discover if the effort or time or dollars spent were worth more than that effort or time or expenditure cost us. This is where we fail: nobody knows the costs they’ve seen.

Let’s use an example which is at the heart of a multi-billion dollar industry (CROs). Are they worth it? How do we know? Generally speaking, we know they are worth it if we cannot get the work done any other way, either through a lack of expertise, manpower, geographic reach or other factors. But let’s look at those situations that are not crisis-driven, where a biopharma is considering outsourcing all of their monitoring or all of their data management as an ongoing strategy. This is a decision that can and should be made analytically. On what basis is this analysis proceeding? Do we actually know what it would cost us to do these activities internally?

You would think that a biopharma that has been conducting clinical research for a generation would have such data at its fingertips, but no one does. They may have data, but it is unusual to find the right data. What is the true, entire cost of a monitoring visit? What is the true, entire, fully loaded cost of cleaning a data field on a CRF? What is the cost of making educated guesses about distributing clinical drug supply among trial investigative sites?

Even more importantly, let’s consider the subtler business decisions we make every day. What is the true, fully loaded cost of designing a protocol that meets the biostatisticians’ satisfaction and uses decade-old FDA-acceptable endpoints, but is not likely to make the new compound stand out competitively? What is the true cost of conducting concurrent worldwide clinical trials for the sake of near simultaneous global submissions? What are the relative fully loaded costs of centralized monitoring, regionalized monitoring, contractor monitoring or outsourced monitoring? The questions are endless, and yet we do not confront them, because of what has so far been a daunting irony: it costs too much to find out how much things cost.

We have always contended that CROs in particular, but now even the fattest biopharma, cannot afford not to understand their costs properly. In the CROs’ case, they are nothing if not cost-driven businesses. How can a CRO properly propose a competitive, fair and profitable bid without knowing exactly how much it will cost them to deliver the service? How can a software vendor properly and profitably price their offering (which after all, in itself costs near to nothing to manufacture) without both vendor and sponsor understanding the true cost-savings using the software will entail? How can a sponsor choose services or software or process improvement implementations without knowing what costs are being affected, and what costs will be incurred, in total?

Why is something so important as this so difficult to calculate? For most companies, “fully loaded” cost is a concept buried inside Finance and, even if discoverable, is not calculated in operational terms (data is gathered and analyzed by Finance in financial line items, not project/study/personnel terms). Most companies have never mapped their actual clinical development processes (not their SOPs) for such tasks as protocol development, site selection or data cleaning, and thus do not know how to assemble the proper elements for which to calculate cost. Instead, most companies use incorrect or misleading measures (if they use any at all).

Let’s look at analyzing the use of software in clinical research as an example. Sponsors think they are doing well when they recognize that software can affect the LPLV-DBL interval. But this is a highly misleading measure. Most companies can find examples of very fast database lock times, using traditional paper methods, through the “heroic” efforts by clinical operations staff. This is confusing when trying to compare paper and electronic data management methods fairly. The confusion comes from failing to understand the difference between duration and effort. It is effort that more accurately captures cost. For instance, the more data points there are on a CRF page, there will obviously be more effort in monitoring it. The right measure to calculate cost, therefore, is not DCFs per page (a common metric) but rather DCFs per “x” number of data points. This comes much closer to calculating effort.

How can clinical research companies do a better job of uncovering their true costs? The first step of course is to realize the issue is an important one, and that it will cost money to save money. The second step is to sit down with Finance, Project Management, Clinical Operations and other important sources of puzzle pieces, and put together the pieces to make the picture become clear. Simultaneously, organize Process Mapping efforts at a sufficient level of detail (not too much, not too little) so you can uncover all the steps in completing the multi-dimensional tasks we do in clinical research. Fourth, determine the correct measures which can be denominated in dollars that accurately reflect true costs. Finally, enlist the aid of all those staff who need to make this effort successful; it cannot be done “to them”, but must be done with them, and the results must be demonstrably used for work improvement.

In the end, you may find that some actions or decisions cannot in fact be justified in dollar terms. What we call the “Value of Necessity” (we can’t get the work done without it) may indeed be the most compelling, and appropriate, reason to choose a service or a product. But in all cases, some day or another, you’re going to have to know your costs. If you work hard at discovering them, you will have the concrete basis on which to measure the benefit of the improvements you work so hard to achieve. And instead of singing “Nobody knows the troubles I’ve seen” to anyone who will listen, you can hum “blue skies, nothing but blue skies, do I see.”

Process Improvement That’s Skin Deep

Process inefficiency and illogic is rampant throughout our industry – in every sponsor, CRO and investigative site. There are many relatively quick and effective ways to improve this situation, and they start with awareness.

Executive readers may protest that their company is well aware of the need for “process re-engineering” and that they have already spent millions to do so. Middle managers will groan at more talk about process improvement because they often have been the “victims” of their executives’ re-engineering projects. The frustration, and lack of impact, that results from these projects comes from the fact that too often, process re-engineering is only “skin deep”.

Does this scenario sound familiar? A corporation decides to re-engineer their company to develop “best-in-class practices”. It spends millions on high-level interviews and executive brainstorming which, predictably, produces high level goals like “triple our pipeline in three years,” or “reduce our costs 10% every year for ten years.” Multi-colored laminated diagrams elucidating the workings of interdepartmental teams are distributed company-wide and imprinted on coffee mugs. These goals become the objectives for middle managers to implement and on which their bonuses will be based. Meanwhile the executives congratulate themselves on having re-engineered the company – they have the wall posters to prove it. The rest is “just details.”

Details indeed. How is a department supposed to respond to a dictum stating “accelerating time to market is a key business strategy”? What is a manager to do with a re-engineering recommendation whose specificity is at a level of “regionalization of monitoring resources may be more productive”? The answer for clinical operations managers is having the skills and tools to apply management action and group process to improvement tactics – to either attack inefficiency or exploit a competitive advantage. The problem is, this is where the money runs out. Corporate leadership is ready to spend millions on the skin cream, but has not been helped to understand the cost of the surgery needed underneath. Even if executives recognize that more detailed work is needed, they find out their discretionary budget has now run dry. So they turn, in time-honored tradition, to middle managers and say: “implement our Seven Points of Light, and do it while you get your regular work done.”

Operations managers may have in fact been deeply involved in the re-engineering effort, at least in terms of time spent in interviews, team meetings and exercises. But often they do not see the results of their input translated into a useful operational plan. In this way, managers feel the process improvement was “done to them”, not for them. The more frequently this happens, the greater the skepticism about process improvement that spreads among all staff.

This irony is repeated every year across our industry. The more it happens the worse it gets. If left unresolved, the inefficiencies create more financial pressure, which in turn demands more effort from clinical operations groups, who then have even less time to correct the problem. Since clinical development is the longest, most costly period in bringing a new therapy to market, it deserves a more sophisticated, deeper approach to process improvement than it receives.

What should companies be doing instead? There is certainly strong value in aligning a vast corporate enterprise around a set of clearly defined business strategies, especially for the sprawling merged entities we have in our industry, or for the CROs who have grown far beyond managing by instinct. But once strategies are in place, those who suggest they are bringing value to the corporation through process improvement have to be willing to get their shoes muddy, and need to have the skills to lead the operations group through that mud.

Clinical operations managers need to anticipate this impact of skin-deep re-engineering and arm themselves with skills and resources to respond, while trying to influence the situation proactively. Here are some suggestions:

Routinely propose budget dollars and resources for process improvement in your annual plans and defend them aggressively

Raise the consciousness of the importance of tactics among your bosses and their bosses

Learn tactical improvement techniques, such as fact-based interviewing and process mapping

Watch out for re-organization plans based on politics instead of process: organization charts are the language of a corporate persona – they are too important to be determined by whose job needs to be protected or how to support a manager’s compensation through headcount

Protect yourself with (and learn from) metrics: measure how you work now so you can see how the imposed changes affect you, for good or ill

Don’t automate a bad process by trying to help it with technology without understanding the process problems first

We will write more about these and other techniques in future columns.

Clinical development is in crisis and superficial re-engineering is not a help. Beauty is only skin deep; process improvement need not be. It is in your hands to make your organization’s inner beauty shine through.