By Kamila Novak, KAN Consulting
As clinical trials get more and more complex, whether in design or due to an ever-increasing number of systems and technologies used during their conduct, sponsors and CROs alike agree we need more efficient trials to get new products, both medicines and devices, to patients faster and cheaper. Regulators as well encourage the industry to boost innovations, improve cost-effectiveness, and increase the speed of product development.
We often talk about leveraging data interoperability, machine learning, artificial intelligence, real-world data and real-world evidence, etc., to support our objectives. Although these are game-changers, they are not a magic wand to get us where we aspire to be.
We tend to forget to talk about the knowledge and skill silos in clinical trials that we have built over the years. Let me give you an example. When I started my career in clinical research in the ’90s, the monitor took care of everything related to study sites, from the feasibility to the site close-out. The monitor selected the sites and worked with them during the study start-up, including contracting, submissions, approvals, preparing documents, compiling the investigator’s Trial Master File (TMF), training, investigational product release preparation, collecting documents for the sponsor’s TMF, then initiated, monitored, and closed the sites. The monitor wrote progress reports for submissions, prepared site invoices and requested payments, kept an eye on study material and investigational product resupplies, and managed filing of documents. The monitor was the “project manager” of sites and countries he/she was responsible for. The monitor knew everything about the sites and patients they recruited. Clinical investigators had one point of contact for all questions and support – the monitor. Yes, those trials used fewer technologies and, from today’s perspective, were simpler, yet the monitor had a huge job and, often, several studies on his/her plate, travelling several times a week, writing reports, following up on data queries, and so on and so forth. The monitor could be dedicated to a whole program of a certain product and, thus, had hands-on experience in product development from an early phase to marketing applications.
When the monitor got promoted and became a team lead and later perhaps a project manager, junior monitors or clinical trial assistants were promoted and became monitors. We grew talent in-house, organically. Yes, there was a turnover, since an experienced monitor could easily move to another company, but it was not difficult to hire new assistants or junior monitors and promote existing staff to higher-level roles.
Over the years, the monitor’s job was split up and many specialized functions emerged. Today, we have roles such as:
- A feasibility specialist
- A start-up specialist
- A regulatory specialist
- A site contract specialist
- A specialist for document review and filing
- A central monitor
- An in-house (remote) monitor
- A monitor performing on-site visits
- A specialist following up on data queries
and probably more I am not even aware of. Count with me: A job that used to be handled by one person may nowadays be done by nine people. The start-up specialist does not know what the in-house monitor does, the in-house monitor does not know what the on-site monitor does, the monitor does not know what the regulatory specialist does, a data manager does not know what a person in clinical operations does and vice versa. Everybody is siloed in their own bubble with their own knowledge and skills; each person sees a tree and hardly anybody sees the forest. This specialization is not very common in small companies, as they simply do not have the headcount; however, the bigger the company, the more prominent it gets.
Let’s pause for a moment and think about the reasons, consequences, and what we hoped to achieve with such a narrow specialization, as well as its dark side.
The 3 Drivers Of Narrow Specialization
The first driver was likely financial. More people involved in trial execution mean more billable full-time equivalents (FTEs). In addition, having been relieved from many tasks, the monitor can be assigned to more studies and perform more monitoring visits, which used to be the main source of revenues for CROs. The latter has become obsolete once we implemented risk-based monitoring. The decreasing trend in the number of on-site visits was strengthened by switching to remote visits during the COVID-19 pandemic and we are unlikely to return to the pre-pandemic modus operandi.
The second driver was probably operational. People whose job is just a small segment of clinical trial operations become experts in what they do and do it very efficiently. While this is true and we reap the benefits in cutting many timelines, there are several dark-side consequences we will talk about later.
The third driver could have been, and this is only my guess, the wish to limit staff turnover. Or perhaps it was just a by-product or a side effect. While in the past an experienced monitor could easily find another job as a monitor or get an offer as a team lead, an experienced site contract specialist is very unlikely to get hired as a monitor by another company. This person’s options are very limited. I remember interviewing applicants, such as start-up specialists, site contract specialists, etc., who wanted to be hired as monitors or senior monitors, stating they have three, four, or five years of experience in clinical trials. They could not understand why I offered them a junior monitor role at a maximum, while they had all those years of experience. However, for the monitoring role, they indeed were junior, knowing nothing about site monitoring, having not done a single monitoring visit so far. They were disappointed and mostly did not accept the offer. Experienced monitors started to be in high demand, a situation that continues today, and companies even offer sign-on bonuses to attract them.
The Dark Consequences Of Narrow Specialization
The dark side of super-specialization is multifaceted. Most people naturally want to progress in their career. This is healthy and desirable. I’m not talking about those who decided to be professional monitors and nothing more; they have their reasons, which I respect. Sponsors requesting CROs to provide them with, for example, monitors with six years of experience in oncology trials, overlook this human need to progress and achieve more. If a monitor is doing a great job, how come he/she has not been promoted in six years? If there was no promotion over the years, is the person really doing a great job and you want him/her in your study? As an auditor, I would strongly advise against this practice. I find most – and sometimes the most surprising – deficiencies during study audits not in the work of people with zero to three years of experience, but in the work of people with the longest history in the same position. Why? The very experienced ones get locked in routines, stop learning, and cease paying close attention to what they do. Of course, after having done the job for 1,249 times, they switched to autopilot. It is totally understandable.
A few days ago, I had a chat with a good friend who worked as a monitor for 12 years. He told me he was leaving his current employer despite being satisfied with his salary, car, bonuses, and appreciation, and he was about to move to another company to start in a completely different role. He said he realized he was not doing as great a job as before anymore, although nobody else had noticed anything. He simply could not continue doing the same thing. Fortunately, he understood that and took action to grow as a professional. Burnout, demotivation, and loss of innovation are the faces of the dark side. Do you remember the movie Modern Times with Charles Chaplin, in which his iconic Little Tramp struggles to survive in the modern, industrialized world, and which shows the effect of repetitive and time-stressed work at an assembly line? Yes, some people may get crazy. If you have not seen it, watch it. It is an excellent movie with a great actor and a message to learn that is still valid today.
We are at a crossroads.
We understand the need to break data silos to get truly actionable insights, but who is going to look at the data and understand what they mean? New specialists? With all the advanced technologies at our disposal, modern study designs, etc., we need people with a holistic view who embrace quality culture and drive innovations. How can we build this workforce of the future?
5 Strategies To Break Skill Silos
One source of potential new employees with a broader view can be graduates from talent development and training companies. Some of these companies offer discounted course bundles to people who wish to work in clinical trials; these include, for example, a course for clinical research associates (monitors) and a course in data management, remote and centralized monitoring, and monitoring oncology studies. People can create their own course bundles or register for all courses to gain in-depth knowledge in many aspects of clinical trials. Good training companies offer rather extensive courses (three to four months per course) and verifiable certificates. Not all course applicants pass, but those who do are well-equipped for their future roles and with the usual on-the-job training become a valuable part of sponsors’ and CROs’ workforces. This source is still underutilized.
Another and a rather complementary source of our process improvement is active listening to newcomers, those who have just joined our company. These people have fresh eyes and are not locked in our routines. We should encourage them to ask questions and challenge our procedures during their initial training on SOPs as well as on the job. The worst thing we can do is to turn them down, mock them, or answer, “This is how we do it. Just learn it and comply.” Some of their questions may be naïve, but we should still take them seriously. I found their questions very valuable when I worked in CROs.
We can organize cross-disciplinary meetings and trainings instead of keeping them siloed in functional areas. I can hear the objection that such things would be neither effective nor efficient. Not necessarily. If our training is traditional and old-fashioned, then yes, I agree. However, we need innovative approaches to training as well. I can easily imagine a training titled “The adventure of a data item in clinical trials” for monitors of all kinds and data managers and perhaps even QA folks together.
We can use gamification and create games such as an Innovation Week, perhaps quarterly. State a problem, e.g., a process or activity that typically causes delays in study progress, then encourage everybody across functional areas to think out of the box and employ critical thinking to propose solutions. Let people come with crazy ideas. The point is not that the idea is crazy; the point is, is it crazy enough to give birth to innovation? Every innovation was once somebody’s crazy idea. Do not be surprised if the best ideas come from people who are not involved in that process and, hence, are not bound by the existing routine.
Why not to get inspired by what hospitals do with young graduate physicians? They rotate through different departments before choosing their specialty. I know, we do not hire ahead of the curve and our headcount is usually lower than what we truly need to do the job. We do not have the luxury of sending people from one functional area to another; we need them to do the job we hired them for. Now. Perhaps our resource planning and resource allocation methods also need to be changed.
Yes, we need to manage change. Everybody with some experience in change management knows the first response is denial. People do not want to be affected by the change. Once they realize they cannot stop it, they move to acceptance and sink into depression. We need champions of change to help them start experimenting with the new process and motivate them to decide and get engaged.
Let’s start this year 2022 with a goal of becoming catalysts and champions of change. Let’s think how we want to conduct the clinical trials of tomorrow and how to get there. Let’s become visionaries of better clinical trials and make steps in that direction. One step at a time, steadfastly, with determination and grit. This is the only way. Do not wait for John or Jane to start. If it were not for visionaries, we would be still travelling on horseback. Let’s wake up the dormant visionary inside us and take the first step. Today.
About The Author:
Kamila Novak, MSc, got her degree in molecular genetics. Since 1995, she has been involved in clinical research in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant focusing on QA and QC, as a certified auditor for several ISO standards, risk management, medical writing, and training. She is a member of the Society of Quality Assurance (SQA), the World Medical Device Organisation (WMDO), the European Medical Writers’ Association (EMWA), the Drug Information Association (DIA), the Continuing Professional Development (CPD) UK, and other professional societies.