“Steering Committees are models of the law of unintended consequences”

We commonly assume that the involvement of senior executives in a project will improve the performance of that project. To that end, we form “steering committees” of such executives to, presumably, steer the project to its shining destination. Too often, instead of steering, these committees are little more than backseat drivers: they can’t see the road ahead, don’t know the route, don’t work the controls, and are lulled to sleep in the moving car. Like the classic backseat drivers, this position doesn’t preclude them from shouting directions and complaining about the ride – even to the point of hoping that the car will just turn around and go back home.

Unintended Consequences

Steering Committees are models of the law of unintended consequences. Do we think we might co-opt our executives into supporting our project by forming an executive committee for them to sit on? Be careful what you wish for! Depending on your company culture and individual executive personalities, your steering committee may turn into a new venue for inter-department conflict. It may draw unwanted, uninformed attention to a project the members did not know about and do not support. It might be the perfect forum for micromanagement. It is commonly the ideal mechanism for stalling, rather than enhancing, decision-making.

Even if you avoid these dire unintended consequences, a steering committee is almost guaranteed to delay your timetable, if for no other reason than since you created the committee, by definition it has to meet. And as an executive committee, by definition, it is very hard to get these folks in the same room at the same time on any regular interval. This leads to all middle managers’ bête noir – executives calling in to committee meetings from their scratchy cellphones from their car or another continent, or both. As we know, as the committee meeting reaches a critical decision point, the cellphone call is guaranteed to drop – perhaps conveniently, if avoiding a decision is the goal.

Overall, the common experience of those living with steering committees is their pure unpredictability. Having formed one, you are stuck with them – you cannot ignore them, hurry them, or argue with them. By forming one, you’ve created a new workload for yourself with unclear benefit.

The Value of a Steering Committee

A steering committee might be useful at three distinct points in a project:

1) In the very beginning, when money and staff resources, departmental alignment, the will to change and priorities all need to be marshaled.

2) At the very end of your project, to dole out appropriate praise to those deserving staff, and to lead a serious lessons-learned effort that generates meaningful knowledge for the next project.

3) During a particularly dire crisis midstream, when only executives can decide about a change in direction, investment, cancellation or expansion, often due to circumstances external to the project that the executives are in a unique position to know about and understand.

Each of these circumstances plays to the precise strength and purpose of executive guidance. They can be critical to your project and the investments being made. The trick is how to anticipate whether and when you will need this important assistance.

These three circumstances are at best discrete moments. The beginning and end points of your project may be benign and easily handled. There may be no crises at all. In which case, if you are preparing for monthly steering committee meetings, and living with the results, you are paying for insurance you may never need.

Other than these three points in time, what the steering committee most needs to do is to stay out of the way. One way towards that is to not schedule regular steering committee meetings on some artificial calendar-based schedule. Having regular arbitrary meetings only invites and legitimizes the backseat driving behavior. If a group meets regularly, eventually they will feel obligated to do something, much like an auditor feels obligated to find something wrong. Nothing is more dangerous than a committee looking for a purpose.

An Alternative

Why are we worried about the impact of a steering committee on decision-making? This is both the heart of the frustration and the solution to the problem. We are mixing up “steering” and “deciding”. You need not automatically abdicate authority to a steering committee because of its name or the rank of the members. It is precisely this abdication that makes this discussion so important. Stalled or misguided decision-making undermines the hard work of clinical development professionals everyday. You hurry to a deadline, only to find that people are not ready for the fruits of our labors. Only the most knowledgeable and best informed staff can make use of your work, and decide what and when to move forward.

In all but the handful of circumstances described above, why do you need a steering committee? Perhaps “steering committee” is the wrong term – you may not need to be “steered” at all, but rather advised, or helped. Can a project or a trial use the advice of senior executives? Can you use their help in getting cooperation from their peers, additional funds, or scientific guidance? Absolutely. But clearly that is not “steering”. Indeed, perhaps we who are running the project should be in fact steering the steering committee – being alert to how they can help, and when.

We are the ones at the wheel, foot on the gas, eyes on the road. You may have even been down this road before, or one very similar to it. You have passengers who can help with the trip, and we welcome executives to come along for the ride. They will enjoy it and we will learn from them. But leave the driving to us.

“Our chief want is someone who will inspire us to be what we know we could be.”
― Ralph Waldo Emerson

As I write this, the US Government is shut down. One cannot help but think about leadership at a time like this. We look to our leaders for many things, but most importantly, we want to be led. We want to confidently place our trust in our leaders – political, religious, business, familial – to take us somewhere better than where we are; somewhere safe, positive, even inspiring. But sometimes it feels like the only thing that is consistent in our work is a lack of leadership.

Far too many of our R&D leaders have feet of clay. There is something about scientific and academic cultures that pre-dispose to passive, cautious, uncommunicative, and untrained leadership. This begs the question of how these men and women became senior management in the first place. Perhaps those that hired them possess similar traits and are hiring in their own image, or that our workplace cultures have grown to reinforce passive leadership. Whatever the reason in your organization, the effect is damaging.

The Clay in the Marble
“Consensus: The process of [searching for] something in which no one believes, but to which no one objects.”
― Margaret Thatcher

Noticing leaders with feet of clay is literally as old as the Bible (see the Book of Daniel). We see signs of clay-footed leadership in clinical research every day. There are many common examples:
• An executive who shields him/herself with an administrative assistant whose job it is to prevent appointments.
• An executive who arrives late to meetings, leaves early, and says nothing.
• Or the opposite – an executive who calls a meeting of the “team” to discuss even the most minor and obvious decisions. (An oxymoron candidate: “leadership team”).
• Most commonly, the feet of clay are revealed simply by the executive who does not respond – to emails, to direct questions in meetings, to any requests for follow up.
• The insidious example: the ones who impatiently drive a group into a new initiative, and once it is launched, they disappear, on to the next.
• Those who only manage upwards (i.e., to their bosses) – these you never see, because they are spending all of their time in their bosses’ meetings, or trying to get one, so that the dialogue of fictional progress can churn without interruption.
• The masters of delay, who have learned that if they wait long enough, the decision will be made for them, or likely become moot.
• And the preservers – the system is what promoted me to this amazing position, I am not going to rock the system.

A Leader Fully Cast
“The day the soldiers stop bringing you their problems is the day you stopped leading them. They have either lost confidence that you can help them or concluded that you do not care. Either case is a failure of leadership.”
― Colin Powell

There are simple, but oh so difficult, answers to this failed leadership. Leaders must heal themselves, or seek the training, to do six things, all day, every day:
Listen, Ask, Decide, Explain, Point, Sustain.

• Listen: Well, first, leaders have to make themselves available in order to listen. Indeed, they don’t have to wait, they can go out to their staff and sites and listen. When a good leader is listening, they are applying their experience and judgment to what they hear, while reinforcing what I will call “controlled openness”, i.e., an openness with sincere limits.
• Ask: Having listened, the effective leader will ask questions, again based on their experience. Not for the sake of showing off that they are listening, but to get at the information that he or she needs, which may be missing, in order to…
• Decide: The leaders we need in research need to decide the issues we have brought to them – quickly, clearly and consistently – having gathered the essential information. If we wanted our leaders to stall, we could easily procrastinate on our own without them.
• Explain: Many research leaders may think that they do listen, ask and decide, but after the decision is where the more serious breakdowns occur. Why your leader made a decision should be clear, and appropriately (not necessarily widely) communicated, with as much frankness as possible. The reason for the decision should be put in context – how the decision fits with company and departmental strategy, with personnel strengths, with budgets and resources. Decisions are a terrific opportunity to reinforce communication to staff on all of these guiding contexts.
• Point: Leaders have a permanent daily role, besides decision-making. We look to leaders to point the way – where are we going and why, what to watch our for, what questions are still to be answered, where there may be pitfalls and opportunities.
• Sustain: Last but not least, leaders must sustain these positive leadership qualities, day to day, month to month. Too often we hear from leaders only in times of crisis or predictable celebration. A stern warning on study timelines, vendor oversight or enrollment shortfalls is followed up with silence, undermining any steps for improvement.

Re-sculpting
It’s very challenging to improve on ineffective leadership from below. If they won’t engage, how do you even have a constructive conversation? You can try to appeal to self-interest, which will vary by personality – are they motivated by money, power, influence, ego? To say they are motivated by scientific excellence is both a truism and insufficient. A more likely path to encouraging, or forcing, improvement is top-down, but isn’t that how we got into this situation in the first place? An ineffective leader is likely the product of a culture that, at least in the upper reaches, is encouraging caution, “getting along”, “team playing”, and “good news” communication. It is precisely this company culture that has to be changed by, yes, an effective leader – bold, decisive, inspiring.

I suspect that we dream about such leaders from birth. We are drawn to them, we seek them, we follow them. Some of us become them. We don’t all need to be leaders, but someone has to. It is never too late, or too early, to find and nurture them.

“Throwing middle management into the deep end after deciding to outsource, without re-defined processes and appropriate training and tools, is not proving to be very effective.”

As we slip into the modus vivendi of outsourcing most or all of clinical development, a full appreciation of the consequences is still missing at many sponsors.

The most important, and apparently surprising, lesson sponsors are learning is how much work outsourcing takes, when the point was to eliminate the work altogether! Short of reversing the outsourcing course (which I am pleased to see is slowly starting at some companies), the next best thing for us to do is analyze closely the operational opportunities to improve the performance of outsourced trials. Unsurprisingly to students of organizational change, both the risk and the opportunity lie with middle management.

Biopharmaceutical sponsors have seemed to react to suboptimal outsourcing from two extremes. One response is that we’ll work it out on the golf course (executive to executive, in the classic pas de deux where both parties are fatally dependent on each other). At the opposite end, a common solution for biopharma is we’ll shadow our service providers hour by hour, and second-guess them to the point of doubling the effort and cost expended, to no benefit of quality or speed.

What makes most businesses work is the middle: middle management is the forgotten, thankless job that sponsors, having already lopped off the lowest doers, are now energetically bulldozing. This leaves a dangerous gap – the management gap, or put another way, the knowledge gap – where the most important locus of performance assurance lies.

The gap in knowledge of how to effectively run clinical development is plaguing sponsors and service providers alike. The emphasis for both parties has been to maintain scientific and functional knowledge, which is essential. But without sufficient knowledge on how to operationalize the science, sponsors become overly reliant on the service provider, or worse impose suboptimal procedures on the service provider (from ignorance or overwork), which leads to conflict, issues and a deteriorating relationship.

The same characteristics of a healthy in-sourced model apply to effective outsourcing: senior management must provide their people with the resources, guidance and support that will lead to success. Too often the concept has been to assume that the service providers will handle everything – an abdication of responsibility. Throwing middle management into the deep end after deciding to outsource, without re-defined processes and appropriate training and tools, is not proving to be very effective.

The Missing Managers

The competency gap comes from a logical sequence:

• Large-scale outsourcing programs cannot be cost-justified if too much infrastructure is left in house.

• Service providers recognize the need to reassure their customers that all will be taken care of in order to win large-scale contracts.

• As departments are decimated, middle managers leave or are let go.

• The normal cycle of learning by doing, and passing it on to newcomers, is dangerously broken.

Service provider middle managers are also endangered by too high expectations. Left alone and in charge, they are trying to manage development programs which need a sponsor’s product-driven self-interest, but from the well-intentioned position of an output-driven factory floor supervisor.

An obvious fix is to improve the quality of service provider middle managers, but service providers have the same problem sponsors do – where do we find the knowledge and talent? The pool of experience is drying up by the day, and both sponsors and providers have widespread problems in hiring. I like to say the challenge in clinical research is not QA (quality assurance) but “CA” – competency assurance – a much harder challenge. With good pre-hoc CA, we can avoid post-hoc QA problems.

And to add to the dilemma, both sides’ middle managers have the added burden of becoming expert both in their particular research function and also at communicating and working with their counterparts. So even in the best case scenario of two sets of fully-funded and well-meaning middle managers, there is often a critical communication skills gap.

We may have to look outside the industry to get the next generation of managers. It may be easier to teach a talented manager about clinical research, than make an effective manager out of today’s overworked and undertrained staff.

Filling the Gap

There are a number of actions that both sponsor and service provider can take to try and fill the gap. First of all, recognize that the basics of management are harder with outsourcing. Motivating people who work for someone else, with different business objectives, is hard. Correcting their under-performance is even harder.

Secondly, adapt and revise internal departmental and trial conduct processes when outsourcing. Internal processes assume short hand-offs between people who know each other personally. When working only internally, misunderstandings can be clarified relatively easily, because face-to-face contact is so much easier to accomplish, and more frequent. Not so, when the service provider personnel are ten time zones away.

Third, devote time and effort to training middle management on the soft skills required to manage service providers (and for service provider managers to serve their customers). This type of management is very different from managing internal resources – for instance, should you say the same thing in the same way to a direct report or colleague within your company, as you should to your customer or provider?

Overall, maintain and nurture your middle manager staffing. If your budget savings weren’t realized in firing the low-level transactional workers, they are not going to come from firing their managers too – a classic case of cutting off your nose to spite your face. Ensure that internal staff learn, maintain and retain clinical development skills. Focus your governance time and efforts at the operational level, not on remote steering committees, and renegotiate the service provider relationship so that both sides are encouraged to invest in the quality of middle management, and adjust expense/funding/budgeting expectations accordingly.

Biopharma clinical research management should consider the wisdom of the London Underground: mind the gap! In our case, it is the gap of knowledge, manpower, process and oversight between the strategic ideas of customer and service provider. If we step too late, we will be falling onto the third rail of an empty track.

“The problem lies not with the new process, but with the old people.”

I have had a peek into the fantasy life of clinical development executives. It is not pretty. Not the kind of fantasies you might imagine – more like fifty shades of self-delusion. The fantasy goes something like this: clinical development is inefficient, a performance drag to drug commercialization – it is no faster than a caterpillar moving along a tree branch. By some form of magic (“extra-lean sigma”, or outsourcing, or motivational posters in the hallways), the caterpillar will turn into the beautiful butterfly that C-officers and stockholders want to look at. This metaphor is precise, because management wants the same development staff to transform themselves from caterpillar to butterfly, without making any meaningful (and painful) changes to people or process. I have been calling this fantasy goal, perhaps too politely, “transforming in place” – that somehow we can change what we do, and how we do it, without making the tough choices. Referencing our butterfly metaphor, I think I will call it “the chrysalis fallacy.”

It is most distressing to see organizations invest heavily in a high-level strategic review, or new information technology, or a major shift in resourcing, after which they then exhibit very little change in their fundamental performance. Often, the problem lies not with the new process, but with the old people.

Most biopharmas have people in place in clinical development, especially in management, who have been in their positions for many years. When confronted with changes in process, technology or strategy, they are naturally resistant. Their managers, in turn, are reluctant to push too hard on these managers because of various reasons: it engenders a difficult conversation, it requires lots of follow-through (and therefore continuing discomfort), or the managers also may not embrace or understand the change. The resistance is not remarkable. What is remarkable is how frequently biopharma development is in a turmoil of change, and yet rarely replace the people in pivotal roles responsible for the change.

There are many examples of process, technology and strategy changes facing us. Reducing source data verification is a big process change; introducing information technology like a new CTMS, web-based subject randomization, or an electronic master file, is highly disruptive; a change in resourcing strategy to more (or less) use of CROs or more (or less) use of functional in-sourcing is an increasingly common, threatening situation.

These changes can be implemented successfully, if not painlessly, even with all the current staff in place. But usually, one or even many key staff are resistant or incapable of managing in the new environment. This is understandable, but must be corrected. Nothing protects people in place like history, loyalty, avoidance and fear. If you or your company have worked with someone for many years, you naturally resist asking that person to leave his or her position. Indeed, there may have been many glorious achievements that they were once responsible for. We feel loyal to people who have performed for us in the past, “watched our backs,” maybe even hired us. Most commonly, we leave people in place to avoid the unpleasantness of trying to move them out, and usually, the company’s policies or national employment laws make the task even more arduous. Last but not least, there can be considerable fear in the situation: how will things work without the people in place who always did the job in the past?

Why can’t we avoid the pain and just leave underperformers in place? The consequences are deadly. The reader will recognize these examples:

— A clinical development executive spends millions with multiple consultants on a “best practices” strategy, but operationally nothing changes

— The latest clinical supplies tracking technologies are employed and a fatal error still ruins a trial

— Another clinical development executive tells her management team the kinds of changes she wants to see, “empowers” the same culpable managers to implement them, and then wonders years later why nothing improved

— A pharmacovigilance department installs the latest technology but the managers insist on using the traditional paper-based processes anyway

— A clinical monitoring leader simply rejects new processes, intimidates his staff, passively ignores the imperative to change, and through inertia, is able to successfully kill the changes over time.

Some people can change, and some people should be given the chance to shine elsewhere. In some cases, people previously stuck in old ways can prove to be highly valuable in a completely different department. In other cases, the classic move of shifting a failing people manager to a newly created position as a senior individual contributor can create a highly productive employee. Freed of daily production responsibilities and their own petrified loyalties to those underneath, they have the time and responsibility to contribute in an entirely new means.

Improving efficiency or timeline performance in clinical development requires considerable alteration in the way we have been used to working. But the chrysalis fallacy whispers that we need not rock the personnel boat; the butterflies will fill the office. It’s a beautiful idea, but probably a fantasy. Get real. Forget the caterpillars and find new worker bees. This metaphor may be mixed, but the results won’t be.