After the Compromise

Ronald S. Waife

“Indeed the safest road to hell is the gradual one–the gentle slope, soft underfoot, without sudden turnings, without milestones, without signposts…

― C.S. Lewis

The biopharmaceutical industry is very much on trend with its emphasis on collaboration in daily work. Collaboration can take many forms and the intent to use it may not match its execution. For instance, collaboration is not inevitably achieved by consensus, but consensus inevitably involves compromise. Each of these terms are used, and misused, as sacred mantras in the meeting rooms of clinical research. Admirable, perhaps, but what happens after the compromise?

Too often, collaboration is seen as an end in itself. This is even reflected in very high-stakes gambles: big pharma is racing to build new labs in concentrated areas like Massachusetts’ Kendall Square and Harvard Medical Area on the sole premise that being next to each other will spark collaboration, which in turn will spark innovation. New office buildings across the industry all feature interior designs with the same purpose, essentially filling available meeting space with “inside coffee shops,” which ironically are doing little but creating meeting room availability crises. Ah, the law of unintended consequences.

But even if we are meeting more “collaboratively” (whatever that might mean), what are we getting out of it? The pressure of the collaborative culture is to get along, and yet show progress. Can these co-exist? The corollary to collaboration –requiring consensus ­– is wrong-headed in itself (why do we all have to agree in order to collaborate or be innovative?), and achieving that consensus predictably requires compromise. These are so highly valued that we specifically judge managers and staff on their ability to succeed in a consensus environment.

But here’s the thing: achieving consensus, and crafting a compromise, is not the end of the story. Someone, somehow, has to implement the compromised solution, without compromising (pun intended) the purpose of the project/action/solution/remediation. Indeed, by definition, a compromised solution is usually a political minefield, containing illogical or contradictory components to achieve the compromise. The devil is in the details.

Compromises

Let’s look at some common modern day compromises in clinical development. In each case, executive or functional leadership have to compromise to endorse the required change, but the implications are left unsettled:

• RBM. The company commits to using Risk-Based Monitoring in the abstract, but has not planned for the changes in field monitoring, site relationships, and data management responsibilities.
• Patient Centricity. In clinical development at least, this new name for a 20-year old concept (ePRO/eCOA) requires new looks at technology and new relationships between development, postmarketing and vendors.
• eTMF. Moving ahead with an Electronic Trial Master File is an activity riddled with compromise among the competing opinions and needs of regulatory affairs, clinical operations, quality assurance and more, and the disagreements are about more or less everything: who, when, where and what.
• Organizing Clinical Development. Since there is no right answer to a “best practice” for this, a high-level solution is inevitably chosen for political, personal, geographic and financial reasons. To reach agreement on your “best practice,” compromise is essential. But then what?
• Strategies for Enabling IT. Ensuring that the use of information technology to enable clinical development is efficient, up-to-date and right-sized is nearly always an unhappy compromise between technology users and corporate IT owners.
• Someone Else’s EDC. A classic compromise in this century is the dilemma sponsors or CROs face in desiring to use only one electronic data capture tool but finding the unsuitability of Phase II/III oriented tools to early phase or postmarketing studies is too painful. Now what?

Obstacles

So life is full of compromises. Why don’t we just get to work? The problem is that the compromise is just the beginning, not the end, but the institutional energy was spent on the compromise and the execution is too easily put off. What is standing in the way of execution?

• Passive resistance, the most common and effective form of corporate obstruction. You made the compromise because of all the attention in the moment; that doesn’t mean you have to help implement it. Just lay low and it will go away.
• Executive disappearance. Leadership may have forced the compromise, but they don’t stay around for the dirty work. Without sustained executive focus, it is too easy for the compromise to be watered down or rescinded.
• One compromise wasn’t enough. How often have you found yourself sweating though a highly visible set of meetings to reach a difficult compromise, only to find out that the differences are entrenched and will continue to be fought out in the details?
• No budget for execution. Implementing a compromise usually costs time, resources, tools and vendor costs. Rarely is this ever budgeted for, especially when (legitimately), the need for compromise was not anticipated.
• It’s not your compromise. A significant obstacle to executing a compromise solution is that the compromise came from another place and time – your boss’ previous job, your consultants’ formulaic answer, your CRO’s insistence ­– without being arrived at in the context of your actual circumstances.
• The compromise was illogical or unworkable. Often there might be a very good reason why a compromise was hard to achieve – it did not make sense. You may be stuck with the consequences of the decision, but the facts don’t go away.

“There is no such thing as consensus science. If it’s consensus, it isn’t science. If it’s science, it isn’t consensus. Period.”

― Michael Crichton

Saving the Compromise

If you are responsible for executing the compromise, beware. You will “pay” for the satisfaction of those who reached the compromise, if the follow-through was not planned for. The original purpose of the compromise may never be achieved and you, the implementer, may be blamed (if anybody remembers your project after a while).

Sometimes compromise is necessary, even essential, and sometime it is wrong. It is wrong if it was arrived at for its own sake, if it was to mollify someone or some function, if the implied solution is unworkable. Sometimes nothing is better than something; maybe it just isn’t the right time to do the right thing. Sometimes a compromise can be saved if given enough room (time, money, cooperation) to fix it.

Several things are paramount to ensuring compromised business decisions in clinical development are beneficial and not harmful:

• Develop a realistic estimate of the cost and consequences of the compromised solution
• Re-evaluate the compromise in the light of your company’s strategic objectives
• Ensure sustained executive involvement
• Be open, sincerely, to re-considering compromises that are either unworkable or no longer compelling.

In clinical development, with lives and health on the line, there is no room for collaboration and consensus for its own sake. We only have time for what works, be it solutions discovered through compromise, or single-minded actions that bring beneficial results.

Operating Assumptions   December 2014

Ronald S. Waife

Honesty is the Only Policy

When was the last time you told someone the whole truth? When was the last time you thought someone was telling you the whole truth? Have you told that under-performing monitor that he is, in fact, under-performing? Did you tell your sponsor about the problems you started having with that investigative site? Did you tell your customer about the true delivery date for the next software release? Did you tell your employees how much bonus you are making from their long hours or work? These are all examples of how, every day, we treat each other dishonestly. You can argue that these “white lies” make work easier, but I would argue they strongly contribute to the highly inefficient state of clinical research. Honesty isn’t the best policy, it’s the only policy.

Widespread and Too Easy

Let me emphasize from the start that when I discuss “dishonesty” in this column I am not talking about criminal behavior – dishonest handling of trial data, noncompliance with regulations, cutting corners in analytical rigor, insider trading, and so on. I’ve never seen them and they are not my point. I’m talking about “process dishonesty” ­– dishonesty in the way we treat each other every day.

There are so many examples of dishonesty in everyday research life that any reader can quickly provide their own list. Here are just a few:

• Sponsors lie to CROs about when the trial is going to start.
• CROs lie to sponsors about the qualifications of who is going to work on their trial.
• Clinicians lie when they say “this is the final protocol.”
• Quality Assurance is often lying when they say “the FDA requires this.”
• Every department lies to each other when they set a deadline, knowing the deadline will be missed and leaving themselves room to maneuver.
• Sponsors lie to their own staff about plans for job elimination or outsourcing.
• Consultants lie when they tell clients what they want to hear, instead of what they found.
• Sponsors lie when they tell consultants they want help with “x”, when they actually want justification for “y”.
• Upper management lies when they tell their direct reports how much money is in the budget for next year, and their direct reports lie about how much money they need.

So okay, this is hardly unique to clinical research and is universal and as old as time. It has survived as standard business practice for so long because it doesn’t seem to matter. But I suggest it does matter, a lot, not just on ethical grounds, but to sponsors who are trying to change their approach to research and make the development of new therapies faster and less costly.

Inefficient Dishonesty

How does all this hurt clinical development, if it is such a standard business practice? Dishonesty and efficiency don’t mix:

• If you put somebody on a team because you have to, instead of because they are qualified, that leads to inefficiency.
• If you can’t tell someone they are not good enough at their job, your employing inefficiency.
• If you avoid the opportunity to provide constructive criticism, that’s permitting inefficiency.
• If requestor and bidder play a game of “chicken” when negotiating a budget, resulting in weeks of delay in the name of “best practice contracting” or Sarbanes-Oxley, the only best practice we are achieving is expert time-wasting.
• We all know the truism that it takes three times, or ten times more resources to fix a problem downstream rather than when it happens. But because being honest upfront is not safe, we’d rather “kick the can down the road”, wasting more time.
• You will not have a chance to really know if your in-house staff has the ideas, skills and flexibility to perform better, if you don’t tell them that their performance issues so dire that you’ve already decided to outsource their jobs.

I think that white lies are so ingrained, they are second nature. We congratulate ourselves for avoiding confrontation, which usually means we avoided the truth. The financial, personal and professional pressures to bypass hard truths are all too real and way too strong. Our slippery sidesteps are all too understandable. And yet if we start to believe our own white lies, no one can save us from ourselves.

Mistrust and Passivity as Symptoms

Our problem with honesty in our research process creates deeper and more subtle negative effects. Mistrust and passivity can be the direct byproducts of a failure of honesty. Indeed they contribute to dishonesty in a nasty feedback loop. We mistrust our CROs and they mistrust their customers because disinformation has become the mode of communication. Our staff mistrust our managers when outsourcing or acquisitions are announced out of the blue. And nobody believes the software vendor’s delivery date, or the first specifications of a protocol, because it is not acceptable for us to acknowledge unpredictability or unreasonable deadlines.

Passivity is a cousin of mistrust and dishonesty. If I don’t trust you, and I’ve learned to speak in white lies, my best course of action is to lay low, do only as I’m told, and otherwise stay passive. No wonder research executives today decry the rampant lack of urgency and energy in their organizations!

Getting to Honest

Diogenes is described as searching high and low in ancient Athens, in vain, for an honest man. Diogenes was also a philosopher of Cynicism, whose modern meaning may be too harsh and excessively pessimistic for this topic. Not only can we find honest people, we can make them.

How do we get more honest in our treatment of each other?

• Make it safe to be honest: I think few of us think we can be honest with our bosses, staff, providers or customers without negative consequences. We need to make honesty permissible and desirable.
• Make it a cultural imperative: we should not only make it safe to be honest, we need to recognize it as a necessity for our organizations’ efficiency, productivity, and respect.
• Educate each other about our jobs or “walk a mile in their shoes”. The more we understand the work, the motivations, the potential and the limitations of the work of others, the more we will understand and accept honestly delivered information, and the more honest we can be in our own communication.
• Demonstrate and model honesty in our own behaviors. We’ve described how this can be risky – who’s going to go first? I don’t think we can wait for the other guy to blink. Instead, we need the courage to trust and respect others enough to treat them with honesty and bear the consequences. In time, we can start a safe and productive feedback loop.

I think I hear the Golden Rule echoing nearby.

At first blush, change management seems like an oxymoron. How can one “manage” change? If it’s manageable, your company doesn’t need a department or consultants to handle it. The change we seek to manage is by definition threatening – in its speed, extent, personal impact or uncertainty. How can such a threatening change be managed? In fact it can be, and must be, but not how clinical research sponsors do it now.

Change management has been too often co-opted by human resources departments, IT consultants and senior management as a cover for downsizing, outsourcing or defending politically-driven, illogical reorganizations or force-fed mergers. In this context, the change to be managed is staff acceptance of events that are not in their best personal interest.

Change management is used to underpin broad and thin executive initiatives that produce little more than PowerPoint slides and posters in the hallways. The resulting mistrust and cynicism is deadly when true change management is needed: who is going to listen, or commit, to a project that looks and smells like the one last month that outsourced their colleagues?

In such an environment, the change management activities that are applied are equally superficial. Employing generic process improvement principles and tools, and led by generically-trained facilitators, the workshops and training and newsletters and self-congratulatory celebrations have more in common with political rallies than serious analysis and commitment to improving process efficiency.

What It Should Be

True change management (let’s call it “TCM”) is characterized by a set of values and actions that reflect seriousness of need, long-term commitment, and demonstrable results. As presently staffed and prepared, it is unlikely clinical research sponsors can pursue TCM on their own without some major attitudinal adjustment.

TCM can and should be about, in part:

• Discovering facts
• Disseminating information with clarity
• Speaking the truth
• Asserting clear command
• Simplifying cross-currents and contradictions
• Recognizing and considering self-interest
• Taking small, frequent steps
• Seeking quick proofs of success (i.e., value)
• Sustaining the effort.

Focusing on these values would be an enormous step forward. It is critical that the emphasis not be placed on tools and training – these are essential, but are the means, not the end. Currently, those clinical research sponsors who claim that they are serious about TCM have only the investments in these mechanics to show for it.

Instead, for any time of change, we have to ask:

• What do we keep
• What do we throw away
• What do we add
• What do we innovate.

It is said that when comparing humans to chimpanzees, 99% of the genome is the same. Quite a difference, that one percent! But the lesson is that change is essentially conservative (i.e., conserving), and therefore should be less scary and more embraced.

It may be useful to think of TCM in Stages familiar to a pharmaceutical enterprise: Discovery, Diagnosis, Therapy and Maintenance. Much as in drug development, TCM cannot be complete without all Stages being covered. It seems that we are always in a hurry when there is a problem, and we jump to the Therapy Stage, skipping all others. When we think we have no problems, why bother with any TCM at all? This is a bit like saying we do not have to do anything for our health until after the first heart attack. The best time to begin the Stages of TCM is now, regardless of your perceived state of health. And all of the Stages are necessary – you have to analyze what you have discovered rather than jump to assumed therapies; you have to maintain the therapy after the initial enthusiasm or fear energized you.

Whatever the right term is – TCM or otherwise – the old “change management” is not leading us to demonstrable solutions to real research operations problems. Rather than using change management as window dressing, we need to institutionalize it as a permanent and sincere effort to better use our resources for the important work we do.