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

Ronald S. Waife

Following the examples of these six companies might change your organization for good.


 In keeping with this month's resource issue, the editors asked me to reflect on 2004's best practices in clinical development process, as seen in real life situations. Being somewhat of a non-believer in best practices (who's to say any practice is "best"?, and why is someone else's "best" necessarily best for you?), I did conclude that I could cite a number of "pretty good" process examples worthy of emulation. All of the following are actual examples; the company identities have been omitted to protect their competitive advantage. If we were giving Best Process Practices Awards this year, these would be the winners.


Mergers are rampant in our industry among companies large and small, and as far as most investors can tell, they run smoothly, even if they don't produce dramatic improvement in the flow of new drugs. But as anyone who has been inside a merger knows, the operational impact can be devastating, and at the very least, highly disruptive. Merger failures include poor understanding of where the strengths lie in the new organization, missing the opportunity to make real operational improvements, trying to keep people happy without regard to business effectiveness, keeping unproductive functions alive,and so on.

One company took a different approach. It decided to act swiftly to analyze strengths and weaknesses in the merged operations, and where necessary, create a new organization chart with re-articulated roles and responsibilities before any final management changes were announced. The analysis was rapid but intense, and informed with extra-company experience. Major re-assignments were made, even of line managers, and in some cases new units were formed for tasks the new company would be much in need of. Instead of the usual postmerger behavior, where a company just looks at the management players and leaves the rest up to them- often resulting in years of slow, distracting upheaval-this company sought to get as much change as possible accomplished quickly. And not change for change's sake, but change that was incisive and potentially transforming. An excellent approach to exploit the operational opportunity mergers present.


We have written before how critical it is to govern change effectively-that there must be empowered leadership, with money and executive backing, and an infrastructure to handle the myriad of tasks necessary to make process improvement successful. Too often in clinical development, we retreat to leaderless teams or matrixed relationships; major change is cast as an "initiative," which leaves individuals and managers free to choose whether they will commit. And without resources, both human and monetary, even strong visionaries cannot succeed.

A large pharma introducing a major change in clinical development made a significant investment in change governance this year. It wanted to move quickly but knew this change was mission-critical with high stakes. The company created a new department, which would operate globally to manage this multiyear process transition. It is a permanent unit, with permanent members formally transferred in. Former line operations staff are now fulltime change agents. Top executives are fully informed and committed to its success. The department is fully budgeted and is resourcing ahead of the curve of need, instead of behind-in itself a major accomplishment at most companies. The company has sought to staff all the roles necessary for change management, from study team mentors to investigative site trainers, and expects to achieve successful, compliant process change in much less time than most of its big pharma peers. The investment in governance is paying off.

Learning from mistakes, sincerely and concretely


Many clinical development groups routinely talk about "lessons learned." They properly seek to understand what went right or wrong with a project or particular trial, so they can avoid repeating past mistakes and remember to do again what they did right. 

Unfortunately, such efforts are usually little more than one long meeting, a flipchart pad full of observations, and a bunch of action items that individuals are supposed to remember for next time. Too often, the "learning" dies on the spot. There is no formal means of documenting the discussion, no one keeping track of actions taken, and no protection from that learning just walking out the door in the head of a departing employee. Worse, the learning is often incomplete: messengers of bad news are afraid of being shot, or the attempt to seek information may not be cast widely enough. Equally common is that the lessons are articulated too vaguely, in words and opinions too familiar to be truly heard or acted upon.

One biopharma with many lessons from a just-concluded pivotal trial decided that learning as usual was not enough. Instead, it used a formal exercise designed to comprehensively analyze and document what it had learned about this trial's conduct. The examiners looked for root causes of problems they encountered, which enabled them to identify broad but meaningful themes whose improvement will impact future trial conduct. These root causes are actionable, not theoretical, and provide a foundation for a diverse set of clinical operations process improvement steps.


We have written many times that measuring our performance can be so useful to companies understanding where and how to devote process change energies. As we have described, those companies who get "metrics religion" often go into overdrive and end up with a vast array of data, and pages of reports, which managers ignore and staff resent. Another flaw in most companies' metrics programs is a focus only on time intervals (last patient visit to database lock, for example), which are determined by too many contributing variables to derive correct conclusions.

An international biopharma has demonstrated that in one area of its operation, clinical data management, it can apply metrics for resource planning, performance monitoring, and technology assessment without falling into either of these traps. By focusing on the "vital few" metrics which are both reasonable to collect and have operational significance to know, it has been able to minimize the practical burden of performance data collection while increasing the usefulness of the results. As importantly, it is focusing on the units of work which best describe operations, rather than abstract time intervals. Using units of work translates much more accurately into management decision-making.

Knowing it's never too soon for compliance


Emerging biopharmas who are just beginning to see their first drug candidate approach Phase III usually continue the pattern of operations which got them there: use a lot of CROs, focus on the science, and ignore clinical development or postmarketing infrastructure. They follow the same philosophy they followed through discovery: I'll buy that next piece of equipment or hire that next person I need the day I need it and not a moment sooner. That can work in discovery, but having the organizational infrastructure for a successful submission and postapproval support is not something one can buy in a moment-it takes time, anticipation, skill, and practice.

Just such an emerging biopharma has demonstrated visionary practice in its small clinical group as the company gets close to submission. It has instituted a broad and deep review of its clinical SOPs, and fleshed them out in the many areas where they were thin. These SOPs also serve to ensure that the company's clinical program is robust right now, as it expands the scope of its candidate's indications, instead of continuing to rely on outsiders' standards. And it has also recognized the importance of creating a legitimate pharmacovigilance function, with the appropriate tools, so that it is prepared to handle internally the safety monitoring that an approved drug will require. In both cases-SOPs and pharmacovigilance-the company internalized a compliant infrastructure at modest cost for many long-term benefits.

Using the right reasons for vendor selection


My last example for the year's Pretty Good Practices is a company who has gone about technology vendor selection more efficiently than most companies do, because it focused on the right reasons for choice. Instead of spending months of intense effort to develop, define, and document the functional requirements for a clinical IT software application (i.e., how should the commands appear on tab 12), this company recognized that such actions would be reinventing the wheel. Clinical IT applications are so well defined in purpose and use that developing functional requirements for them de novo is akin to specifying how a word processor should work.

This company instead focused on business requirements: that is, what did the company need from the software and its vendor, rather than how the software should look or act. It focused on the imperatives it was facing, the skills of its staff, and the financial and time constraints of its particular development program at this point in time and the foreseeable future. These characteristics are not the same among all biopharmas; indeed they can vary greatly. And having identified what it felt was important, the company found specific, meaningful differences among the products and vendors that a functional review would never have revealed.


There are common elements in these Pretty Good Practices: boldness, speed, simplicity, and honesty. These are qualities sorely lacking in most pharmaceutical development operations. When you see them, good things are likely to follow. Whether or not the specifics of these stories apply to your company at this moment in time, these qualities will always serve you well.			

Articles

Pretty Good Processes

Move away from the "service" model if it means being subservient.


For many years now, it has been fashionable to work on corporate processes by encouraging a "customer-vendor" relationship between departments. I have been as guilty of this as anyone. In listening to the problems facing clinical development departments recently, however, I have come to realize that this concept is either misapplied, misunderstood, or simply a mistake. Unless great discipline is exerted on all sides, "customers" are poorly served and "vendors" are exploited.


The original concept of treating each other like we are each other's customers is drawn from many good intentions, and merges many process improvement philosophies and techniques. At my company, we use a "voice of the customer" technique, for instance, which emphasizes this style of thinking. TQM (Total Quality Management) teachings of various flavors use this terminology. Process Mapping-the visualization of complex workflows-is sometimes presented in this fashion: Who is your customer? Whose customer are you?

In many ways, talking about each other as customers is not unlike the Golden Rule: treat your organizational colleagues the way you would want to be treated. Using terms like "customer," "vendor," and "service" puts a warmer face to "inputs/outputs," or "deliverables."  

Customer orientation as a corporate process concept was long overdue when it first appeared. Most companies-pharmaceutical companies among them-desperately needed to overcome the detrimental "silo" ideas to eliminate the pointing fingers of blame, and to show the interdependencies people share in a complex organization.Examples of such poor relationships at pharma companies were (and still are) legion: between clinical operations and clinical data management, biostatistics and medical affairs; regulatory affairs and product marketing; investigative sites and monitors (CRAs); chemists and pharma-cologists; informatics and everybody.

But there are problems with this kind of language. For instance, if everyone is everybody's else's customer, is anybody "making" anything, or are we all just "buyers" expecting to be served? In fact, not everyone is a customer of someone else. Sometimes, for instance, people are other people's bosses. Sure, you can treat your boss as a customer, but it may be more important to follow his or her leadership rather than think about delivering him/her a service. Sometimes our colleagues are simply sources of money, or data-neither customer nor vendor. And sometimes we have nothing to do with each other, but if the mantra of customer-vendor is too ubiquitous, the corporation may be insisting that these folks develop a time-wasting connection in the blind pursuit of popular jargon.


More importantly, there are two fatal flaws in the everyone-is-a-customer approach. First, even given the legitimacy of the concept, the true "customer" of our work may in fact be at a much higher level than who we are trained to serve. For instance, the customer who is worthy of that name may not be the next person in the handoff chain, but rather the Clinical Development function as a whole, or your biopharmaceutical corporation, or the regulatory agencies, or even the patients you hope to help. Unfortunately, the customer focus approach almost exclusively encourages a pragmatic, heads-down, make-the-next-guy-happy mentality. This may not actually help your organization at all, if the focus should be at a much higher plane. 

Secondly, the concept of "service" is misused. If we have customers, then we are supposed to "serve" them. This is where the customer concept can get really deadly. When we start to think about "providing a service," and then turn this into "being of service" to our customers, if we are not careful we can end up being "subservient." These words all sound pretty similar, but subservience means being a servant; it implies that the customer is better than we are, or more importantly, subservience means the customer's needs are more urgent than ours. It doesn't have to be this way, but when we overlay the customer focus superficially and without diligent rigor on age-old interdepartmental rivalries, that's what we end up with.

 Clinical Data Management "vendors" take the customer focus philosophy to heart and concentrate on serving the clinical study manager. In doing so, they are forced to choose between losing their carefully built-up standards, structures, and efficiency, to serve the study team with flexibility. 

 Monitors focus so much on sites (their customers) that they allow consistently poor site performance in enrollment and data quality for the sake of "satisfying" that Key Opinion Leader.  

 Clinical operations is intimidated by its site "customers" into paying them more to use EDC (electronic data capture)-a tool which will in fact lower site workload if used correctly. 

 Biostatisticians give their physician customers in Medical Affairs everything they ask for despite what this does to the timeline, or despite the fact that the data may not yet be properly cleaned or of sufficient volume, or that the questions the physicians are asking take the company's eye off the ball. 

 Clinical operations tries "serving" CDM, and in trying to meet CDM's stringent view of data cleaning, ends up with an inefficient monitoring schedule and that classically unnecessary task: 100% SDV (source data verification).

In fact, having customers and serving them are not inextricably linked. It is possible to be customer-focused and yet not be subservient to your customers.  "The customer is always right" does not mean that the vendor is always wrong. 


One way of looking at "customers" without becoming subservient is to see each other as equals, not servants. After all, if everybody is somebody's customer, we are equal. And equality brings several characteristics into play which are very healthy for a corporation: mutual respect, boundaries, expectations with limits, and a common multilateral goal, not a linear production line goal. It allows the Clinical Development department to focus above the level of the next handoff, and concentrate instead on the plan, the submission, or the patient. And it ensures that each profession can determine which of its values are corporate-critical.

How do we get to be equals? Good will and strong leadership are certainly essential, but human behavior and entrenched practices often require a little extra help to change. Fortunately there is a well-established concept in this regard: the Service Level Agreement (SLA).

SLAs are an invention of our service economy, and while they have been used in many industries, the concept is not widely applied yet in pharmaceutical firms, especially in drug development. An SLA looks very much like a contract. It spells out responsibilities, timelines, expectations, deliverables, authority, change procedures, and problem resolution. As such, it documents what one may have documented in a Process Mapping exercise, but does so in the language that societies have developed over centuries to bind people to a common purpose.

Initially, people often react badly to this concept. Why do we need a contract when we have worked together for so long? Why don't you trust me/like me anymore? Spiteful behavior can ensue: "Well, if you're going to write that down, I'm going to write down this!"  "If you want this done on time, how about you doing this for me on time!" And as petulant as these sound, this is exactly the point. The SLA becomes a tool to generate an open dialogue that, without it, simmers below the service. The SLA's formality uncovers flaws, resentments, or missed expectations that were never articulated otherwise.

In the end, by going through this process, you may not need the formal document-just trying to write one may be therapeutic enough. But we are so increasingly interdependent across clinical development, and across all pharmaceutical company departments. This documentation of how that interdependency will be managed to both the corporate good and the successful treatment of patients may be necessary, at least for a few years, until old habits die off and mutual respect and understanding become second nature.

When your waiter tells you "I will be your server tonight," he or she represents in fact a range of products and services-the chef's creativity, the cook's execution, even the delivery truck that brought the raw materials. And you have your responsibilities as well-to arrive at the restaurant on time, to know what you like, to treat the staff well. The delicate flavors, the perfect ambience, a lovely wine are all the result of a combination of lots of people providing you a terrific meal, plus your ability to be ready to enjoy it. They are not your servants, and you are not a burden for them to bear. And as equals, server and served, customers all, we can go home well satisfied with a meal, and a job, well done.            

Not at Your Service

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.

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? 


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 

 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 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.


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

 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.

 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.

 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.

 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.

 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.            

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

You're Trumped!

According to the Bible, we should have been resting every seven days all these years. If only we could have such a schedule. 

Many of us in clinical research find ourselves working part of every day. Our regular workdays are filled with meetings and teleconferences, our nights and weekends are filled with real work: reading, writing, planning, thinking. And all too little of the latter, because we are too busy following through on action items from all those meetings.

Meaningful process improvement in clinical research is hindered by a cultural cataclysm: a Julian calendar in a digital age. We are still scheduling our time by the rhythms of the planets, while communicating in digital time. This cultural dissonance results in two fatal flaws: the unnecessary weekly meeting and the under-use of enterprise information, which could take its place.


The reason why our workdays are filled with meetings is the tyranny of arbitrary frequency. When we get our department or team together, what is the first thing we talk about? We decide to meet once a week! Why? What is the connection between seven solar days and the needs of the work at hand? Maybe we should be meeting every three days. Maybe we only need to meet every 11 days. We never consider these possibilities; instead we book yet another weekly meeting into our PDAs. The result is that we are either meeting too often or not often enoughrarely just right.

Unnecessary meetings are perpetuated for several flawed reasons. One is the tyranny of the team, something I have written about previously. Indeed, it is often hard to tell which is worsethe teams or the meetings they generate. We also suffer through meetings of habit. Think about the spectrum of your weekly meetings, and ask yourself: when did this meeting first begin? There may have been a good reason for it originally, but is there still? Or are you meeting out of habit, because its the way we always do it. When I was once running a large organization with a number of senior managers who reported directly to me, we of course started meeting once a week. After a while, the meetings were getting thin in content; mostly we talked about the latest gossip or personal news. I realized the management team was running well enough that we didnt need to meet, and I changed it to a meeting on demand schedule: any of the managers could call a management meeting when each others counsel was needed. As long as I did my job correctlystaying in touch closely with each of them individuallythis new system worked very effectively. An hour of our workweek had been liberated.

We also suffer from meetings of inclusion, not dissimilar from the ubiquitous team meeting. These are the meetings we have when we dont want to leave anybody out, or hurt someones feelings. We want to keep up with corporate political correctness, or were trying to be inclusive of others. Inclusion is only worthwhile if it is sincere, and if so, it can be insightful and mind-bending. If we are including people for the wrong reasons, you can be sure they will feel it very quickly, resent the waste of their time, and thereby undercut our original cynical purpose.

The worst and most common sin, of course, is having meetings where people look at each other and have nothing to say or learn. Many observers have advised cogent fixes to this problem. In the words of one successful manager, if people need an agenda for a meeting, they dont belong there. One of the famous and most effective ways to make meetings efficient is to hold them in rooms without chairs. Its amazing how fast those meetings go.


But beyond making meetings more efficient, we have to question their frequency. Our work rhythm is no more dictated by the rotation of the earth and moon than any other natural phenomenon. So why are we meeting every week?

What is a week? A biblical invention, perhaps. It is at best an arbitrary subdivision of the lunar cycle, adjusted to the frequency with which the sun rises and sets, the two cycles of which do not line up mathematically. And anyone familiar with the tortured history of the creation of the Julian calendar will remember that our months are even more arbitrary (indeed, the calendar looks very much like the product of a committee meeting!).Similarly, when we ask for reports, we ask for them monthly. Why monthly? Is that frequently enough? Is it too often? Who knows? We let the moon decide how frequently we will summarize and communicate information. Whats important is that meetings and reports (i.e., information) are tightly interrelated. If we had more timely information (reports), do we need the meetings?

Well, sure, you are saying, but weeks and months are what everyone is used to and its easier this way. Weekly meetings, for instance, are the safest way to fight that fiercest of corporate battles: booking the conference room! But to accept these arbitrary schedules as inevitable is a cop-out. 

From daily work to weekends and back again


Before the rise of the corporation in the twentieth century as the dominant form of employment in industrialized societies, we all worked every day. We had to, to keep animals fed, wood chopped, water carried. But we had many fewer meetings! And each day had a rhythm that naturally included some fresh air, exercise, family, and quiet. In the last century we became boxed into the structure of the work week, creating the phenomenon of the weekend. No longer did we have a fluid continuum of daily tasks with little discrimination; instead the lines were clearly drawn between work and leisure, and an artificiality was introduced.

With the advent of ubiquitous, intrusive, and all too easily accessible communication technologies, our weekends have now all but disappeared. The globalization of clinical research, and its resultant round-the-clock phone calls and air travel demands, have further eaten into whats left of free time. Thus is the price of the Digital Age. But if our world is digital, why are we still meeting once a week? 

If technology has ruined our free time, it is because we are keeping both behavioral archetypes in place: the Julian and the digital (the weekly meeting and the cell phone). The bottom line is that I suspect most meetings do not have to happen weekly, and most reports are needed more often than monthly.


In clinical research, all of our operational processes are about generating information, some of it of a defensive nature like regulatory record-keeping, and some of it mission-critical to enterprise decision-making: keep developing the drug or kill it? Most organizations have long recognized that information technologylisten to the semantics of that phrase!can help manage this information. Unfortunately, as anyone who has tried to acquire or design a good CTMS knows, these software applications have focused much more on getting the data in than on getting useful information out. Once we get better at this, we can envision information when we need it, not prepared on a schedule determined by a cold gray orbiting celestial body.

Perhaps technologies can be put into service to restore free time, and a near-agrarian rhythm to our lives, by enabling just-in-time meetings and real-time reports. Instead of double-booking unnecessary weekly meetings (whose agenda is often filled with speculation about information unavailable because we dont have our monthly report yet!), we can start meeting only as often as needed. And the meetings we will have will be so much more informed, and therefore shorter, because operational data will be at our fingertips.

From the day we arrive on the planet
And blinking step into the sun
Theres more to see than can ever be seen
More to do than can ever be done.


Lets not waste that time in unnecessary meetings, scheduled by the arbitrary rhythm of our planet. There is so much to be done.

Arbitrarily scheduled meetings eat away at valuable time otherwise spent actually getting things done.

The 11-Day Week

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?  

One of the toughest tasks an executive will face is to take a talented, well-respected, hard-working manager and reassign him or let her go. It is so tough, that many executives do not do it. The most common response to an underperforming 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.  

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 may have 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 his 1969 book, 

). 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. This is not just about firing the old-timers—plenty of young rising stars are promoted beyond their experiential foundations to positions that better suit senior personnel.  

The team approach to so many clinical research processes 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 effectiveness leading team B—the person may burn out, or the person may not recognize that what worked for his or her 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 that cannot afford underperformers, or that do not 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 in which 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.” Because I am enamored with baseball metaphors lately, think of leaving the long-time star pitcher in the game an inning too long—it hurts everyone, including him, if you do not 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 do not get fired from their families (much as we may sometimes 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, underperforming aunts and nephews.   

The relevance of the underperforming manager to clinical research is evident in many ways:    

 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.  

 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.  

In my experience, the most common cause for a failure to fire is fear. Usually, this fear is based solely on inexperience with the process, and thus it is a self-perpetuating stalemate. Executives do not learn how to move someone out of a position, so they 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. Few want 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 to make the decision as soon as all the evidence is in. Talk to your peers, superiors, and examine the person’s direct reports, but do not be afraid to follow your instinct. You are paid to 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 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 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 does not 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 comes.  

Moving ineffective personnel out of critical positions can be a difficult but necessary management task.

When to Hold ?Em, When to Fold ?Em

When new products come to life in the postmarketing period a significant and growing amount of clinical research continues to be performed on a drug or device. Indeed recently published information indicates such research volume is rising more rapidly than preapproval research, albeit from a much smaller base.1 This trend is all to the goodmuch important information about therapies and diseases can be found by increasing postmarketing research among patients in real-life settings, which cannot be accomplished by the inherent scientific constraints imposed on investigational trials.

Sponsors are increasingly realizing, however, that more rigor needs to be applied to postapproval researchnot that there are issues with subject safety, but rather that poor clinical operations process in postmarketing trials means inefficiency and lost opportunity. 

For many reasons, postmarketing studies are conducted differently than investigational research. Regulations are fewer or nonexistent in some circumstances. Research performed under full good clinical practice is very costly. And, by definition, once the therapy has passed regulatory muster, the safety and efficacy have already been proven through the exemplary rigor the industry follows. Much postapproval research is initiated and performed by individual investigators (in so-called IITs), who simply have an interest in pursuing a personal hypothesis, or who want to keep track of patient experience in a manner more organized than is possible in a regular medical practice. Given such circumstances, it is natural for sponsors to take a pragmatic approach to research after a therapy has come to life.

The incidence of postapproval research is particularly high among medical device companies, where many new products receive approval as variants of existing devices, and thus are not required to undergo long and complex investigational trials. In these circumstances, rigor in following an approved device seems unnecessary and unproductive to many device companies. It is also true that for drug companies, which are large enough to have dedicated postmarketing or Phase 4 units, physical or organizational separation from the investigational side of the company can lead to a philosophical and tactical separation as well.


When it is suggested that postmarketing units are not rigorous enough, those units often (naturally) react with great defensiveness. But in doing so they are missing the pointit is not a question of patient safety or regulatory compliance, its a process problem. Its a business problem.

Reduced rigor in postmarketing trials runs up against two imperatives. One is increasing regulatory attention, the other is integratability of all sponsored research. Regulators are increasingly asking sponsors to follow their drugs in a systematic manner postapproval, and as has been famously publicized recently in the 

, many of these studies are long delayed. Some of these studies have been a condition of the FDAs approval of the drug or device. These studies are delayed or incomplete for many reasons, in part because of the inherent difficulties in conducting research in the live world, but also because the units charged with conducting this research are not used to operating under investigational research standards.

The internally-driven imperative for more rigor in postapproval studies is more widespread. Increasingly, sponsors seek to combine the data, the processes, or the enabling operational technologies (or all three), of both investigational and postmarketing trials. There are several drivers for this. One is the desire to use outside operational assistance (such as that provided by CROs) more judiciously; one way to achieve that is to leverage internal investigational and postmarketing resources to help even out each others workload. Another similar driver is the desire to leverage the significant investment companies have made in clinical trial software systems; in doing so they find they need to align processes, or they risk confusion and poor control. But the key driver in tearing down the wall between pre- and postapproval research processes is to be able to integrate these two rich data sources. 

If an IIT, a registry, or Phase 4 subject experience trial reveals something exciting from a therapeutic or competitive standpoint, it is enormously more cost- and time-efficient for a sponsor to be able to use that data directly, and not have to run a good process trial from scratch to reproduce the findings. Sponsors cannot predict when they may want to use postmarketing data for a label extension, secondary indication, or competitive claims. When the opportunity strikes, data units in postmarketing organizations have to scramble to apply rigor retrospectivelysomething notoriously difficult to do.

The worst thing about a sponsor having two different perceptions of clinical data (pre- and postapproval) is that it creates two groups of staff and two process universes that are incompatible. The skill sets and processes, and therefore the people themselves, are not fungible or shareable. The separate creation of SOPs, training programs, parallel networks of trial monitors, and incompatible overlapping data systems, is highly inefficient.


 I contend that sponsors have nothing to lose and everything to gain by doing all trials to the highest reasonable standards the first time. Rigor might seem more costly, but it is a lot like qualityquality does not cost money, it saves money. The cost of rigor in postmarketing trials cannot compare to the cost of rerunning a trial under stricter standards or of trying to clean a trial retrospectively. The cost of rigor cannot compare to that of losing out on a label extension or to a competitive claim. Neither can the cost of rigor compare to the cost of asking an unprepared staff in crisis mode to help with a regulated trial using procedures with which they are unfamiliar.

The irony is that what we are talking about here is mostly just good clinical practice, something every sponsor knows well. Postmarketing units need to learn more from their premarketing peers. (And while they are talking with each other, maybe investigational trial units can learn from the innovative trial design and technologies which are often first used in the postmarketing environment.)

Technology also helps. If applied properly the evermore ubiquitous electronic clinical trial tools can help enable rigorous processes. And those tools can make it easier for smaller postmarketing research staffs to do more with less. Equally exciting are electronic tools which enable researchers to reach out into patients daily lifeelectronic subject diaries and similar toolsso that the experience of patients outside of the clinic, or outside the artificial constraints created by preapproval trials, can be recorded and analyzed for insights into how to make a good product better, or how to take an alternate tack in a therapeutic strategy.


Of course, not all trials postapproval need be run with investigational rigor. By the very nature of the free enterprise of science many of them could not be run with investigational rigor even if you wanted to do so. Marketing trials can be useful in building provider relationships and in enabling small research that would never otherwise be funded. And some research, like long-running registries, can only be cost-effective if managed in a lean manner. In all these cases, some research is better than none. With minimum safety and compliance standards met, the only thing being compromised in such examples is the potential scientific value, or perhaps the integratability of the data.

But sponsors are recognizing they need to be more careful about this, and err on the side of rigor rather than laissez-faire. The cost of doing small research that is not reusable, or that interferes with the development of an efficient postapproval safety profile, is too high. If necessary, build a wall between those who work under preapproval regulatory requirements and those who support investigator-initiated trials or patient registries. Recognize that these resources will not be fungible. Recognize that the data will not be easily merged, if at all. Recognize all this, and plan accordingly. When there is a hint of wider use of the research results, move it quickly back over the wall to the side of rigor.

Take a long look at how you handle your postmarketing trials. Better processes may be more cost-effective. Better science may breathe new energy into those products of yours that have come to life. 


1. CenterWatch Editorial, Clinical Grants Market Decelerates, CenterWatch 1 (April 2003).            

Postmarketing research is conducted differently than preapproval research, but data gained using different standards can be difficult to integrate.