My daughter is learning how to drive.
In the U.S., driving a car is almost part of our DNA. For most of us, we learn to drive in our late teens and then continue to drive for the majority of the rest of our lives. At some point, we sort of forget we had to learn how to do it. As a parent, I was reminded of the learning process when I recently had to teach my 16-year-old daughter.
“Left-right-left” was an early lesson I remembered after dusting off the cobwebs, and one of her first lessons from me. We did what most families do. We went to a vacant school parking lot on a quiet late Sunday afternoon. The multitasking of switching between using the gas and brake pedals, checking mirrors, and so on is best learned around as few obstacles as possible. As the sun went down, we practiced some other fundamentals like turning on your lights and using your high beams.
How quickly we forget about the fundamentals we once had to mind with such deliberate attention. It is hard for me not to draw constant parallels to my work with clinical research teams and how easy it is for anyone executing the same processes every day to take the fundamentals for granted. Left-right-left is a lesson in situational awareness and avoiding collisions. A “collision” in a clinical trial would be something like an inspection finding. As a fun exercise, here is how I combined these ideas:
LEFT – First Things First
I explained to my daughter that it's important to check her left side first as she approaches an intersection since traffic to her front left, direct left, and left rear is moving toward her the most quickly. Therefore, it’s most likely she’ll have a collision with a car coming from her left if she’s not paying attention.
For a clinical trial, looking left first is equivalent to focusing on these tasks at trial initiation: starting the site selection process; creating regulatory packages; training team members on the study details; requesting setup for all tools needed for the study, such as the EDC system, ePRO devices, CTMS, TMF, and Site Portals; sharing investigator essential document packages; and ordering the investigational product.
Conversely, “looking left” in a clinical trial is more about how to get started efficiently to avoid unnecessary challenges versus stopping safely to avoid a head-on collision. A sloppy approach to basic start-up activities is a good way to increase your risks.
RIGHT – Complete Awareness
After we shifted our gaze to the left and made note of any activity on that side, I guided my daughter to move her gaze to her right to observe traffic on her right front, right side, and right rear. I explained this was also a good moment to check her immediate rear as she was shifting her gaze across her windshield.
Obviously, potential collisions are not limited to any particular side. Getting the full picture of both sides is essential for safety. As drivers, we have to mind our entire field of vision. We could be pulling up to a stop too quickly and hit another car or pedestrian, or we could pull out too quickly and misjudge oncoming traffic. Our eyes give us the ability to collect information.
In clinical research, our systems afford us this perspective as we make decisions and acquire information for the upcoming execution phase of the clinical trial. We anticipate start-up timelines to understand the risks of moving ahead too soon or waiting too long to prepare for trial execution. We ask questions like:
- Are we getting the document packages back in time to go to the first patient and first patient visit for a particular site?
- Is site selection going according to schedule, or have we anticipated a risk and defined potential back-up sites?
- Do we have enough laboratory kits and investigational product for each of our sites?
- Do we have the required import/export licenses on file if shipping internationally?
- Are local IRB/EC approvals on track overall and by site to meet the study enrollment timeline we committed to our company?
- Real-time analysis of these variables, like a shifting glance to the right, keeps you operating on schedule and within budget.
We need to anticipate and synthesize this information quickly to make the best decisions and avoid missing a potential problem that appears in the distance but is in fact rapidly moving our way.
LEFT – Driving in Traffic
In the U.S., when driving on a road with more than one lane, it’s generally the rule that you stay right unless you are passing or need to be in the left lane to make a turn. That said, I explained to my daughter that she must keep a steady eye on her left as that is where traffic will frequently be closest. Also, I advised that if she is changing lanes or making a turn, she needs to return her gaze to this side to ensure a safe entry into her lane.
In clinical research, keeping the end in mind is important, but there is a concurrent activity that requires real-time oversight. These activities are the “closest” to us, and small misjudgments (like missing documents, misfiled documents, incorrect metadata, etc.) impact compliance and inspection readiness. This sets you up for a collision with regulatory agencies, out-of-control timelines, and increasing operational costs. Failure to double-check information and processes can lead to delays in site initiation and distribution of investigational medication; slow enrollment, which can cause an extended study timeline; an EDC database not available for the first patient's first visit; CRAs unable to conduct timely monitoring visits; and missing deadlines for database locks.
If you are currently working in an active study, all of this likely sounds elementary. I’m nearly 30 years into a career in clinical research, and it’s equally easy for me to operate on instinct from repeating the processes in a study so many times. It’s the very same as my ability to drive without even thinking about the steps I’m taking to observe the road I’m sharing with other drivers. The thing about effective approaches, though, is that they are repeatable. My daughter is able to learn how to navigate the road safely with tried and true methods of observation for situational awareness.
Clinical research professionals are in the business of situational awareness. Patient lives are at risk. So are millions of dollars. Fundamentals tend to remain relevant, even as the means to execute them evolve. We have seen so much change, from paper to complete digital document management, remote patient monitoring, and investigator product distribution and delivery, remote site initiations and visits, remote inspections, and so on. Similarly, we have cars that alert us to vehicles or pedestrians nearby.
However, mindfulness of the fundamentals ensures that evolutions in technology are effective, because the humans leveraging them are supplementing the limits of technology with trusted know-how.
Whichever way you approach your research, don’t forget to watch the traffic around you and keep your eyes on the road.
For help with your clinical trial documentation strategy, please contact us at firstname.lastname@example.org.