August 2024 SOCRA Source Journal - Journal - Page 21
If a key staff member is out
of the of昀椀ce for a sick day,
vacation, or parental leave,
other research team members
may not have access to all of
the information needed to keep
things going. When a key staff
member leaves, the site is left
with huge challenges, such as
onboarding a new employee
to all of the technology. It is
critical to ensure that the right
personnel at the sponsor and
the CRO are informed of the
change.
Ongoing Technology Problems
for Clinical Research Sites
Simply adding more technology
has only exacerbated these
issues. Much of the technology
is not intuitively easy to use. It
does not work across all studies.
Often, technology does not
work for all studies even within
a given sponsor. Using all of this
technology requires signi昀椀cant
changes to work昀氀ow at the
clinical research sites. While
there is some technology that
adds value for clinical trials,
much of the technology being
used is poorly conceived and
designed. Companies often
offer terrible customer support.
The way in which clinical trial
technology is being developed
needs to be redesigned. Clinical
trial technology development
must move from sponsor-built
to collaboratively designed
with clinical research sites
engaged in every step of
the development. Heavy
information technology must
be replaced with lightweight
information technology. Elegant
design of technology must
replace complex and resourceheavy designs.
Technology that works for clinical
research sites must be study
neutral, not sponsor-speci昀椀c.
The pharmaceutical industry
has been making an effort
to develop a very expensive
approach to pull together data
across sponsors and studies.
In theory, this concept is great,
however, the execution has been
terrible. Sites have been left with
another piece of technology that
is more time consuming to use
than the old systems.
feedback than in the past. This is
a great start.
Clinical research sites need
technology that works around
how sites function and is intuitive
from the start, not technology
that requires more training.
Research team members do not
need more training modules
to complete.
Now technology is being
developed for sites with
solutions that work across all
sponsors. This technology is
simple yet elegant and designed
to collect feedback from sites
on the technology that they are
using and provide that feedback
to sponsors. This feedback is
not being collected in a single
survey at the end of the study. It
is real-time feedback when the
technology is being used.
In spring 2022, the author
(Trafford) started speaking up
on these issues. On LinkedIn,
he posted about decentralized
clinical trials, the need for
clinical research site-centricity
in studies, clinical trials training,
and other topics. The response
has been exciting. The author
has connected with other
people who are passionate
about these issues. All research
team members should join the
discussion about issues that are
important to sites. Research
team members who are not
comfortable posting can follow
people who are posting and
comment on or like their posts.
If enough people speak up
about these issues, there will
be movement in a positive
direction. Sponsors, CROs, and
technology companies are more
interested in engaging clinical
research sites and soliciting their
Also, a new paradigm for
technology development for
clinical trials is being built, in
collaboration with many clinical
research sites to gather input
from the end users. Clinical
research sites no longer have
to accept that technology is
only being built and developed
according to sponsors’ direction
and needs.
A New Paradigm for
Technology Development
Technology can solve problems
when considered in the right
way. Solutions are more than
a clinical trial management
platform, an electronic data
collection platform, or something
clinical research sites pay a
vendor to provide. They should
be considered more broadly.
Solutions can be as simple
as the research team sharing
information using a Google
spreadsheet. Some solutions
are for individual members
of the research team, such as
one person using a password
manager. Solutions can be big or
small, and paid for or free. There
are many solutions available,
SOCRA SOURCE © May 2024
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