The missing piece in clinical trial site training
Behind every successful clinical trial is a team of site staff working under immense pressure to manage protocols, meet regulatory requirements and navigate endless systems. Which leaves little time to strengthen the human engagement skills that make participants feel valued and supported.
Because when these particular skills are reinforced by training, the consequences are real. And the benefits go far beyond participants satisfaction. As people feel truly engaged, recruitment is smoother, retention increases and data quality becomes more robust.
In this article, the first of a 2-part series, we explore the daily challenges faced by clinical trial staff, the impact on participants, and why sponsors should be prioritising and protecting time for soft skills development alongside protocol training.
Balancing pressures while building connections
Sites need to meet tight timelines, leaving little room for meaningful interaction. Day to day task lists include meeting exacting protocol requirements, staying on top of documentation and maintaining regulatory compliance without missing a beat. So, there is no surprise that in such a pressured setting, there is little protected time to focus on the relationship-building skills that make participants feel valued and supported.
Administrative tasks consume the bandwidth needed for connection. Complex trial management systems, lengthy forms and continuous process updates can take hours out of a coordinator’s day. While essential, this work often pushes personal engagement to the margins, sometimes leaving participants feeling more like data points than partners in the research.
Training often focuses on the technical at the expense of the personal. Site staff training commonly prioritises protocol adherence, safety procedures and recruitment tasks such as eligibility checks and consent discussions. Research shows that while these are essential for compliance, they do little to prepare staff for the skills needed to support and engage participants, which are crucial for keeping them in the study.1 Retention depends on rapport, trust and an ongoing relationship built through regular, open communication. Without structured time to develop interpersonal skills such as empathy, active listening and reassurance, staff are left to learn them informally, creating inconsistency in the patient experience.
This is why programmes that protect time for building empathetic communication skills are so valuable. For example, the Duke University Engagement, Recruitment and Retention (ER&R) Certificate Programme provides structured blended learning for equitable and inclusive engagement, recruitment and retention, with assessments showing increased staff comfort with these objectives after completing the programme.2
Why the right training matters
When participants feel heard and respected, they are more likely to stay engaged in a study, follow instructions carefully and share accurate feedback. Conversely, feeling overlooked or unheard can lead to disengagement or withdrawal, creating costly delays in recruitment and gaps in data integrity. The ER&R paper also highlights that barriers exist at protocol, system and community levels, which training can help staff identify and address earlier.
This is not a reflection of staff commitment or compassion, but a signal that the system does not give them the time or space to develop and practise patient-facing skills that matter as much as technical accuracy.
And so, a question…
What could change if interpersonal and patient engagement skills were given the same priority and protected training time as protocol mastery?
Human-centric training is not about replacing operational rigour; it is about completing the picture. Programmes like ER&R show how structured time and practical tools can build confidence and competence, leading to more inclusive recruitment and stronger retention.
The challenge is not whether staff want more training to support their connections with participants, but whether the structure of trial preparation allows them to do so. And that is something that industry have the power to influence, and to change.
In our next article in this 2-part series, we will explore what sponsors can do to give site staff the tools and time to connect with participants as well as the protocol.
References
- Cranfill JR, et al. J Clin Transl Sci. 2022;6(1):e123.
- Coffey T, et al. BMC Med Res Methodol. 2022;22:231.
