August 2024 SOCRA Source Journal - Journal - Page 20
Clinical research site ef昀椀ciency
is tanking. Study participants
are being made responsible
for more things. As such, while
“patient centricity” is the new
buzz phrase and what we should
be working together to achieve,
many technologies create an
environment that is not patientcentric. At the same time,
because of the inef昀椀ciencies, site
income is decreasing and the
disconnect between sites and
sponsors is growing.
Most clinical research
coordinators may have a
background in nursing, medicine
or health sciences training, Now,
thanks to the technology used
in clinical trials, the new study
coordinator needs to be more
like an information technology
customer support specialist.
Clinical research coordinators
should probably be called
e-CRCs.
The technology that clinical
research sites are using is
causing more problems than it
solves (Table 2). There are too
many tools. Based upon the
Society for Clinical Research
Sites 2021 survey, most research
team members must log into 20
or more technology platforms
each day. These systems
are fragmented and rarely
communicate with each other,
creating data silos.
Research teams must constantly
maintain active rolodexes of all
of the critical contacts at both
the sponsor and the CRO. Staff
changes at the sponsors and
CROs create confusion and
inef昀椀ciencies at sites. Clinical
research sites do not have a say
in which platform is used nor
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TABLE 2
Technology Challenges in Clinical Research
•
•
•
•
Too many tools
Too little connectivity
Too many contacts
No site input or voice
a meaningful way to provide
feedback on the technologies
that they are using. A feedback
loop where sites can provide
information to sponsors on
technology used in trials is
nonexistent.
Solutions for Clinical
Research Sites
As always, clinical research
sites have developed their own
solutions to these problems.
They are organizing their
website links in spreadsheets
or using browser bookmarks.
Some sites use third-party
password managers that are not
built for clinical research.
Research teams waste
an enormous amount of
time searching notebooks,
spreadsheets, contact lists,
and clinical trial management
systems to 昀椀nd the necessary
information. They use giant
whiteboards to try to keep
critical information available for
all of their staff and are rarely
able to keep sponsor contacts
up to date. Some sponsors
send questionnaires at the end
of a study to obtain feedback
from clinical research sites,
however, this is rare. When
sponsors do ask for feedback,
the questionnaires rarely ask the
right questions.
SOCRA SOURCE © May 2024
Solutions developed by clinical
research sites add considerable
risks to the sites. The measures
used to manage the technology
are often not secure or
shareable. Often, the solutions
are tied to one staff member
and may be stored locally on
one device. They are dif昀椀cult to
manage and maintain. These
solutions are not scalable for
sites that are growing.
All of this creates ef昀椀ciency
bottlenecks, access issues,
communication de昀椀ciencies,
protocol deviations, and
ultimately, a less effective
clinical trial. It is critical for
clinical research sites to consider
risk management when using
technology in clinical trials.
Imagine that the lead study
coordinator at a clinical research
site leaves the site. With the
“Great Resignation,” this is
happening to an increasing
number of sites. It would take a
great deal of time to get a new
study coordinator up to speed.
Probity Medical Research has
more than 100 investigators and
300 study coordinators. Every
week, new study coordinators
start and need to get up to
speed. At the same time, staff
are leaving, most often for jobs
at CROs.