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.