Operations

The Importance of Seeing the Whole in Clinical Trials

Operations

14:00, March 8 2017

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Arthur Fernandez, Director, Drug Development, Bellus Health, describes ways to increase productivity and reduce turnover

A Tale of Two Jobs

In 1996, I was hired as a clinical research project manager (CPM) in a full-service clinical research organization known for recruiting young professionals (they’re less expensive). It was expected that I would be working directly with clients, regulatory agencies, statisticians, analytical chemists, FDA auditors and clinical-trial personnel. I was also trained continuously on the job by our supervisors in the intricacies of pharmacokinetics.

I found the work to be varied, scientifically and operationally interesting and an excellent way to learn how to run a clinical trial from contract signature to delivery of the final report. In fact, delivery usually meant going through the satisfying experience of physically packing and carrying the heavy boxes of data-laden binders for pickup by courier (and if we missed the deadline, sometimes delivering these boxes by car to the courier ourselves).

In 2001, after five years of working in this underpaid and demanding yet learning-rich job, I was hired for a similar role by the Canadian affiliate of a US-based multi-national pharmaceutical firm that had an excellent scientific and ethical reputation in our city. My pay immediately increased by 50 percent, with a healthy signing bonus to go along with it. It was a difficult offer to refuse, especially with a growing family. I decided then that I had no interest in working anywhere else. My first days into the new job had a few surprises.

On my first day, I had to sign a document pledging that I would never carry anything heavy (e.g.  data-laden binder boxes). This was for insurance purposes, of course.

I soon learned that the number of people I had to keep in the loop with my assigned projects extended well beyond what I was accustomed to: Head Office liaisons, my colleagues, supervisors and various departments (regulatory affairs, legal, data management, procurement, etc.).

Reliance on fairly obsolete communications technology was policy. In 2001, despite its preeminent importance, external communications with our clinical investigator partners and others were restricted to faxes. This was for legal reasons, of course.

It was soon obvious that any direct agency that I had enjoyed in my previous role would henceforth be mediated. Where once I had directhands-on influence and effect on the conduct of a study, in this new job I felt I had donned a pair of velvet gloves. The conventional wisdom that the strict division of labour brings efficiencies in large organizations, with larger projects, was not consistent with my experience. It seemed to me that this industrial-era approach to production, with its strictly constrained functions, was arbitrary and unnecessary in an information-era enterprise.

With respect to training, we were required to gain skills that had nothing to do with the science or business of drug development. Instead of learning about say, statistics or study design, I found myself at off-site seminars learning “soft-skills”, such as dining etiquette. A few years later, as the company faltered and layoffs began, there were consultant-inspired change-management seminars, complete with (oddly unconvincing) images of burning oil-platforms.

As the company’s fortunes continued to falter, my job description changed, but the title remained. Instead of “doing more with less” as one could expect following layoffs, my role as CPM began to be curtailed. Certain functions I was responsible for were transferred to others within the firm. Eventually, I became, in essence, a study start-up specialist. After six years at the firm, I left.

A Few Lessons from Admiral Hyman G. Rickover

The world’s first nuclear-powered submarine, the Nautilus, was launched and commissioned in 1954, only three years after it was authorized. It was built under the direction of the maverick Director of the Naval Reactors Branch of the US Navy: Admiral Hyman G. Rickover.

He was known to be difficult to work for, he had a visceral hate of bureaucracy and incompetence, but in just three years, the number of startling technical achievements and overcome hurdles that went into the development of this revolutionary submarine are too numerous to mention here. Moreover, the still-unblemished record for the safe operation of US naval nuclear vessels can be directly attributed to certain still extant core values that Rickover established: People, Formality and Discipline, Technical Excellence and Competence, and Responsibility. When asked about how he has maintained, over several decades, an accident-free nuclear fleet, his reply made an important point1:

Over the years, many people have asked me how I run the Naval Reactors Program, so that they might find some benefit for their own work. I am always chagrined at the tendency of people to expect that I have a simple, easy gimmick that makes my program function. Any successful program functions as an integrated whole of many factors. Trying to select one aspect as the key one will not work. Each element depends on all the others.

In my first job as CPM, my responsibilities increased as my career advanced, in my second job as CPM, I had responsibilities taken away. Speaking to people above a certain corporate level was discouraged. Adm. Rickover took the opposite approach2:

One must permit his people the freedom to seek added work and greater responsibility. In my organization, there are no formal job descriptions or organizational charts. Responsibilities are defined in a general way, so that people are not circumscribed. All are permitted to do as they think best and to go to anyone and anywhere for help. Each person then is limited only by his own ability.

Adm. Rickover had no respect for hierarchies (such as found in large organizations), he wanted input on problems from everyone involved, from the lowest to highest ranks. He encouraged dissenting opinions and took them seriously. He recognized that seemingly small problems can become big ones very quickly. His “Formality and Discipline” was not about etiquette and hierarchy, but about properly documenting all decisions, including the disciplined process of extensive consultation and deliberation that led to them.

As a CPM in the larger firm, I found responsibility to be diffuse and difficult to pin down, Adm. Rickover succinctly clarified its meaning1:

Responsibility is a unique concept: it can only reside and inhere in a single individual. You may share it with others, but your portion is not diminished. You may delegate it, but it is still with you. You may disclaim it, but you cannot divest yourself of it. Even if you do not recognize it or admit its presence, you cannot escape it. If responsibility is rightfully yours, no evasion, or ignorance, or passing the blame can shift the burden to someone else. Unless you can point your finger at the person who is responsible when something goes wrong, then you have never had anyone really responsible.

Adm. Rickover felt he was responsible for the ships he helped build from the moment they were approved to the day of their decommissioning. He believed strongly in institutional memory, as it resides in people, and had no use for what he termed “transients”, who remained on the job for only short-term assignments.

How then could the above apply to improving the management of clinical trials?

First, the various and traditionally circumscribed functions in clinical research ought to be re-thought, widened and even overlap. This applies equally to innovators and CROs, of whatever size. Serious thought should be put toward training personnel from one function to work in other functions, as needed and according to ability.

Second, a holistic understanding of an ongoing clinical trial needs to be fostered with all stakeholders. It is only from everyone’s shared understanding of the project, in its entirety, that people can work purposefully and effectively by keeping the right focus on the critical tasks that help the organization meet its objectives.

With advances in information technologies and their increasing ease of use, many functions in clinical research, such as monitoring and data management, could be more integrated and intertwined.One of the advantages that could accrue from this intra-organizational cross-pollination is a greater understanding of each other’s needs and priorities which, in turn, can bring more points of view to bear on seemingly intractable issues. This could also be an antidote to the blight of high personnel turnover by fostering a desire in people to remain in an organization where career growth, according to one’s abilities, is encouraged.

Admiral Rickover’s take on this is enlightening2:

Human experience shows that people, not organizations or management systems, get things done. For this reason, subordinates must be given authority and responsibility early in their careers. In this way they develop quickly and can help the manager do his work. The manager, of course, remains ultimately responsible and must accept the blame if subordinates make mistakes.

As subordinates develop, work should be constantly added so that no one can finish his job. This serves as a prod and a challenge. It brings out their capabilities and frees the manager to assume added responsibilities. As members of the organization become capable of assuming new and more difficult duties, they develop pride in doing the job well. This attitude soon permeates the entire organization.

Great accomplishments are made primarily with pride and enthusiasm. Most of us with jobs intuit that we are capable of much more. It takes leadership and humility to recognize that the people in one’s organization, if left to grow with engaged guidance, prodding and trust, do get to do amazing things with commitment and purpose.

 

Arthur Fernandez, M.Sc., MBA (January, 2017)

 

 

References:

  1. STATEMENT OFADMIRAL F. L. "SKIP" BOWMAN, U.S. NAVY DIRECTOR, NAVAL NUCLEAR PROPULSION PROGRAM, BEFORE THEHOUSE COMMITTEE ON SCIENCE,29 OCTOBER, 2003.
  2. Doing a JobThe Management Philosophy of Adm. Hyman G. Rickover; Excerpted from a speech Adm. Rickover delivered to Columbia University in 1982

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