Turning site initiation into a performance multiplier
- Site initiation represents a psychological fresh start, when motivation and openness to change are naturally highest.
- Completing training does not ensure readiness; early trial issues often stem from gaps between knowledge and real-world execution.
- Readiness is demonstrated through scenario-based screening, consent role play, and simulated protocol workflows.
- Early use of retrieval, explanation, and confidence checks helps surface risks before first patient visits.
- Designing initiation activities to match how sites actually work can reduce early deviations and slow enrollment.
Every clinical trial has a birthday—I’m pretty sure that sentence has never before been written, but hear me out!
There is a day when a protocol stops being an abstraction and becomes a living project in the hands of coordinators, investigators, and patients. Most of us feel that moment instinctively as a clean slate. Behavioral scientists have a name for that feeling: the Fresh Start Effect.
The Fresh Start Effect describes the power of a milestone event. After traditional temporal landmarks such as a new year, a birthday, or the start of a semester, people are more likely to begin diets, visit the gym, or commit to long term goals. These landmarks help us mentally separate our “past self” from our “current self,” which makes it easier to believe that we can do better this time. These events also elevate our thinking to a higher, more strategic level where long term goals matter more than short term effort (i.e., ‘Slow thinking’).
Clinical trials have numerous temporal landmarks of their own. The first investigator meeting. The site initiation visit. First site activated. First patient in. These are natural fresh starts. The risk is that we treat them as operational milestones instead of effective change management potentiators. If we intentionally marry the Fresh Start Effect with rigorous readiness at site initiation, we can convert an emotional window into a measurable multiplier for trial performance.
‘Training completed’ is not evidence of readiness
Most sponsors and CROs already invest heavily in startup training. Travel is scheduled, slide decks are presented, sign in sheets are completed, training records are filed. On paper, the operational milestone is achieved. Yet across the industry we still see predictable problems in the first months of a trial: slow screening, uneven enrollment, protocol deviations concentrated in early visits, corrective training after inspection findings.
The root cause is not a mystery: training completion is not the same as site and staff readiness.
Readiness is the predictive ability of individuals and teams to perform the behaviors a protocol requires, in the context in which they must actually perform them. The launch of a new trial is when motivation is naturally highest and attention is most focused. That is precisely the moment to ask, in concrete terms, “Are we truly ready to execute this protocol?”
Consider a few examples.
- Readiness to screen. As an element of site initiation and training, coordinators should walk through realistic patient vignettes and decide who is eligible. They can identify tricky exclusion criteria and explain how they will find potential participants in their own clinic schedules. A short, scenario based assessment reveals whether they can apply the inclusion and exclusion criteria accurately, under time pressure and with imperfect information.
- Readiness to enroll. Investigators and coordinators can practice how they will explain the study in plain language, using the actual consent form they will have in front of patients. Role play exposes where explanations drift into jargon, where equipoise is not clear, and where common patient questions catch the team off guard.
- Readiness to execute the protocol. Nurses and pharmacists can simulate dosing and visit workflows, including visit windows, necessary labs, and safety reporting triggers. Simple checklists and job aids can be tested in these simulations, then refined before the first real patient ever arrives.
In each case, we move from “you attended training” to “you have shown that you can do the work.” That is the essence of readiness.
Fresh starts as multipliers
Why link readiness to the Fresh Start Effect? Because site initiation is more than an operational milestone. It is a psychological opening.
At the beginning of a trial, people are more willing and motivated to:
- Reconsider their habits.
- Accept new workflows and tools.
- Invest effort in learning activities that feel harder, such as retrieval practice, case discussions, and explanatory questions.
When you ignore this opening, when you default to passive ‘check the box’ training, old habits reassert themselves, overconfidence creeps in, and the planning fallacy quietly reappears in the form of optimistic assumptions about how quickly sites will “figure it out.”
If we embrace the fresh start, we can do something else. We can design launch activities that leverage the most well-established best practices from learning, cognitive, and behavioral science.
For example:
- Use retrieval and explanation instead of only presentation. Ask coordinators to explain key procedures back in their own words, or to teach a colleague. This exposes illusions of understanding before they reach patients.
- Build confidence-based checks into site initiation. Assess not only what a coordinator may or may not know, but also how confident they are in that knowledge. Where confidence is high and knowledge is low, you have found “errogance” that needs to be addressed before the performance risk emerge.
- Frame desirable difficulties as an investment. When role play, simulation, or micro assessments feel harder than listening to slides, acknowledge that effort is essential for learning and link that effort explicitly to fewer deviations, fewer reconsents, and smoother monitoring later.
In short, we can use the motivational lift of the fresh start to support exactly the kind of effortful investment and learning.
Fresh starts happen on their own. Readiness does not.Clinical research professionals have the opportunity, at the ‘birth’ of every trial, to combine the two. When we do, we respect both the science of human behavior and the professional obligation to run trials that are not only feasible, but truly ready for the participants who trust us with their participation.
Brian S. McGowan, PhD, FACEHP, is Chief Learning Officer and Co-Founder, ArcheMedX, Inc.
