At clinical study sites, technology can be both a boon and a burden. When implemented well, technology solutions help staff to be more engaged with patients and more effective in their work. But that work can also be hindered by less-than-optimal approaches to technology.
When site professionals discuss technology-related burdens, we
hear most often about:
Duplicative technologies, which lead to wasted time and frustration.
Insufficient user acceptance testing, so sponsors miss out on end-user input from the site
staff who will use the solutions in the field.
A lack of adequate support from service provider help desks.
Across-the-board training requirements that result in seasoned site staff repeatedly
participating in rudimentary education.
So
when it comes to technology, how can sponsors and CROs be better partners to
their sites?
Consider site preferences for technology systems.
Sites
often invest in technology solutions, such as an eConsent platform, that staff
learn thoroughly and use across studies. When sponsors and CROs insist on
different software for specific trials, site staff must master new platforms
and processes—a time-consuming and redundant task.
When
sponsors accept and adopt site-selected technology solutions, they benefit from
the time and resources sites have invested in those platforms. Staff feel a
sense of ownership in the system and gain proficiency that only increases as
studies progress. That proficiency and institutional knowledge help curb
protocol deviations that result from technology failures.
By
adopting a site’s technology, sponsors and CROs will benefit from greater
efficiencies throughout a study. Because clinical trial solutions are designed
for interoperability, sponsors and CROs that share their APIs make site
partners more effective in their work. They also strengthen the sponsor-site
relationship.
Prioritize user acceptance testing.
Before site staff begin using study software to enroll
patients and capture critical data, sponsors and CROs should prioritize user acceptance
testing. This gives sites the opportunity to provide feedback on technology readiness
and reliability and allows sites to familiarize themselves with technology before
introducing solutions to patients.
Once sites offer their feedback, technology providers must be
willing to address concerns through product updates. This process could be
built into contracts, with sponsors and CROs requiring that technology partners
offer satisfaction surveys at sites and report the results. Vendors would then
be asked to develop and follow a plan to mitigate user-reported issues.
Expand technical support.
We have heard from our site partners that service provider help
desk techs are often unfamiliar with the clinical aspects of study protocols.
Help desk support is also often available only during business hours, even for
sites that see patients in the evening or on weekends. To bridge this gap, sites
should have access to a sponsor-affiliated expert with deep knowledge of both
the protocol and the systems and who can serve as a liaison between site staff
and service providers. Sponsors and CROs could also provide training so support
techs better understand the clinical requirements of a trial and how those
requirements impact the ways their software will be used.
Make training requirements more flexible.
To demonstrate site staff competency, sponsors and CROs often resort to requiring even experienced professionals to complete rudimental technology training. Often, training courses are designed as if every staff member is research-naïve.
Site staff frequently tell us that required training does not meaningfully improve their performance. It does, however, divert focus from their core responsibilities. In the 2023 Site Landscape Survey, the Society for Clinical Research Sites (SCRS) surveyed its members regarding training requirements. Forty percent of respondents reported that, on average, each site staff member spends five to 15 hours on training per study, while 25 percent of sites say they spend between 15 and 20+ monthly hours on training per person per study.
When developing training requirements, sponsors and CROs
should be working from a strategy. If the aim is to impart knowledge, they need
to know what kinds of education would be most valuable to the site staff. If
the goal, however, is simply to prove to regulators and others that site staff
are competent and qualified to perform their duties, such demonstration can be
accomplished through means other than mandatory training. For example, site
staff would welcome the chance to self-attest to technology competence to
fulfill competency requirements.
40% of sites said each site staff member spends 5-15 hours on training per study.
When selecting clinical trial technologies and creating
policies around their use, sponsors and CROs are learning to consider more
fully the needs of study sites. As we reduce technology-related burdens, we will
free site staff to focus on their core mission. As a result, these
professionals can spend more time recruiting and serving patients, using
systems that they understand well and trust to be reliable. All of this can lead
to faster startup and fewer protocol deviations. It also helps site staff feel valued
by their study partners, which can positively impact productivity and
performance.
As sponsors and CROs, we select sites based on their experience and demonstrated capabilities. Remembering that, we need to take advantage of expertise within the sites, allowing site staff to contribute to decisions about technologies. Site expertise should also be a factor in determining training requirements, which should be customized based on staff experience. By including sites in technology strategy, sponsors and CROs can select systems and processes that best serve the entire study team.
By Karen McIntyre, Vice President of Global Site Alliances, Parexel
