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Finding Efficiency in Clinical Research

Urgency Room! (Clinical Researcher, December 2016)

One of my friends in the biotech industry explained the business with this metaphor: working in biotech was like running full speed at a brick wall, and at the last possible second, the brick wall would disappear, only to be replaced by another brick wall farther ahead. Those brick walls, of course, represented critical milestones, such as another round of venture funding, or a research result, a regulatory filing, and so on. It was the idea of running full speed that stayed with me. While common enough in small entrepreneurial companies, that sense of speed, focus and anxiety is rarely found in pharma, despite lip service to the contrary. Where is the sense of urgency in clinical development?

This is not the say that we do not all work hard. It is not to say we don’t care about the progress of our work. But it is to say that at most pharmaceutical companies, day-to-day, we have neither the energy, direction or discipline to conduct our operations urgently. And there are so many reasons to do so! Deadlines, stock options, competition, everyday failures, demanding bosses – not to mention the patients with few, unsatisfactory options waiting for our new therapies.

Some of us (people and companies) certainly may start with enthusiasm. But particularly at the clinical stage, so many factors build up to weigh us down: the myriad inherent delays, the disappointing scientific results, the bureaucracy of corporations and regulations, the unavoidable time intervals of research itself. This is all true, but that’s what we are here for – “that’s why they call it work.”

Most companies have institutionalized processes for complacency, rather than for urgency. Some have become standard behavior since they are so familiar:

  • Slow contracting with CROs
  • Slow payments to vendors and investigators
  • Slow IT projects that are completed years after originally estimated
  • Slow adoption of already-approved process changes
  • Slow responses to poor performance metrics
  • Slow reporting of information requested by operational staff from report programmers
  • Slow protocol development
  • Slow document review and approval
  • Slow study start up.

How many of these do you take for granted, and assume they are inevitable? But they are not inevitable; they are all human-driven! These are not immutable laws of nature; these activities are slow because we allow them to be! There is nothing standing in the way of speed except the lack of will, the lack of urgency.

Another anecdote: during the beginning of one of my first consulting assignments, I mentioned to my client (a junior vice president) that my invoice hadn’t been paid. He stood up, told me to wait there, and left his office for about 20 minutes. He came back with a paper check and handed it to me, apologizing. Ok, I was spoiled for life, but the point is, of course it’s possible to get a check cut, a report run, a contract signed, a meeting scheduled! It just takes a person to do it.

Not all delays – maybe not even most – are caused by perverse obstinance. Think of the many things that fill our days instead of urgent work – emails, meetings back-to-back and triple-scheduled, teleconferences where you can’t hear what most of the people are saying. It’s all too easy for our days to slip away. What most of us are not doing is comparing our tasks, our to-do lists, our schedules, to the most important work list of all: what are the goals of my organization, my department, my project? How is what I am doing right now serving those goals? What does deciding this issue, or reading this email, have to do with moving closer to these goals?

Changing an environment from complacency to urgency requires some bravery and lots of leadership. Let’s look at some examples:

  • You’ve been in a team meeting all morning, getting close to the end of a long project which is supposed to develop a new set of evaluation criteria for your CRO’s. The leader asks if all are in agreement, and one key member says, “maybe, but I have to check with my boss. We’ll get back to you.”
  • You’re working with a statistician on completing the FSR. It’s not due until next month, but you’re very nearly done and it would be advantageous to get it submitted early. You call her up for the third time that day, and find out she’s gone home, and will be on vacation for two weeks ­– something she neglected to tell you about.
  • You got approval to add someone to your staff at the beginning of the year but HR still hasn’t send you qualified resumes. When you pick someone to interview, it takes weeks to schedule her (or she has already found another job). When you try to take matters into your own hands, you are scolded for not following procedures.
  • You’ve finally scheduled a teleconference with a key opinion leader who is very hard to reach. You need the data manager in on the call but he is in another building on campus and says it’s too far to walk. You could tie him into the telecon, but he points out (correctly) that his accent is too thick to be well understood over the phone.
  • Marketing has been warning for years that you need real world patient experience data to be competitive with your new allergy medication. But despite what your competitors were accomplishing, regulatory was still skeptical about approval. Instead of engaging with data management on the issue, they keep asking to see one more demo from one more vendor.

I am sure you can provide many examples from your own organization. What’s missing in each of these situations is someone to speak up ­– not to argue the issue but to remind all involved that we are holding up the improvements, the decision, the work. And that our work is urgent: we needed to hire that new person yesterday, we needed that new software yesterday, we needed that data yesterday, we needed those sites ready for FPI yesterday. And once having spoken up, we need to pursue the resolution to a quick closure, using whatever channels of authority are necessary. Equally essential is the commitment and vocal backing of executive leadership to make clear that urgency is an organizational value and priority.

To a healthcare team in your local Emergency Department, questions of priority, focus and speed are regularly and clearly answered. They know how to triage, how to follow emergency care protocols, how to choose and listen and analyze and solve with calm, professional urgency. We all need this essence­ – to triage our work lives and cut through the low priorities. And we need to encourage our colleagues to do the same, so we can bring our collective focus and precious energy to the meaningful work our companies and organizations are doing. It’s why we chose this profession; let’s do it with urgency.

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