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International Clinical Trials
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Engagement has been established as a key concept in clinical trials over
the past decade. The trend has delivered significant benefits for
participants who, rather than being unconnected from the study between
site visits, now engage in a continual technology-enabled dialogue with
their trial. Yet, having implemented systems that improve the patient
experience, the industry has overlooked the potential for engagement
technologies to benefit two other key stakeholders: sponsors and CROs.
Sponsors
and CROs have first-hand experience of the value of these technologies.
The rise of mobile devices has enabled them both to oversee a major
transformation in the relationship between clinical studies and the
participants they enrol. In the past, this connection has been
relatively distant. Once a patient signed up to take part in a trial,
their interactions with the study were limited to occasional site
visits. Between visits, participants were expected to continue to comply
with the study protocol and were given varying levels of support and
encouragement to help them with this sometimes onerous task.
Over
time, even well-intentioned patients can start forgetting to take their
medication, missing site visits or may eventually drop out of the study
altogether. The inability of a trial to retain participants marks a
failure to maintain the enthusiasm that drove individuals to enrol in
the study in the first place. In 2016, there is no excuse for not taking
steps to keep subjects engaged in a trial, and keep them aware of the
importance of their contribution. Since the rise of SMS text messaging
and, subsequently, in-app notifications, studies have had access to
technology capable of supporting a continual dialogue with patients.
Sponsors
and CROs use messaging, as well as the additional features available on
smartphones, to make it as simple as possible for patients to commit to
– and stay committed to – a clinical trial. While technology has
facilitated these advances, it has also created further challenges –
notably by dramatically increasing the volume and variety of data
sponsors and CROs need to manage. Clinical studies now accrue data on
site performance, compliance and multiple other metrics.
These
data are potentially very valuable for sponsors and CROs and, therefore,
the clinical trials they oversee. They can yield insights that can
improve the performance of an active study, or deliver lessons that
enable sponsors and CROs to design better trials in the future. However,
the sheer scale of the datasets can make it difficult to uncover such
insights and lessons without committing excessive time and resources.
Technology
has simplified patients’ relationships with clinical studies. Now,
there is an opportunity to do the same for sponsors and CROs.
What is Needed
The
challenge facing sponsors and CROs is one shared by companies in
multiple industries today. Organisations in every sector can – and are –
tracking a wider range of metrics with greater precision than ever
before. What is needed are technologies that can intelligently connect
and handle the large datasets generated by these activities. Currently,
the ability of CROs, for example, to derive insights that improve the
performance of an active clinical trial is hindered by the fact that
data are siloed within each module of a study, making it hard to monitor
overall performance.
As a first step, sponsor and CRO
engagement technologies must pull down unnecessary silos, enabling each
type of organisation to access all of the data they are permitted to
see. While such a system would remove some of the barriers currently
obstructing the data-to-insight workflow, it would still leave sponsors
and CROs to shoulder the burden of organising and making sense of the
information. Instead of just having access to a mass of raw data,
sponsors and CROs need tools that can sift through and package the
information in a way that is meaningful to their operations.
This
entails going beyond simply gathering and storing data. The next
generation of clinical trial tools must also process and analyse the
information in a way that yields meaningful insights and
easy-to-understand reporting. Even today, this is far from trivial.
Clinical studies are complex operations with multiple data inputs and
types of end user, each of whom needs access to different information to
do their jobs effectively. In some situations, the details staff are
permitted to access are limited by regulations, adding an extra layer of
complexity for technological solutions to consider.
As such,
the ideal system would distinguish between different types of data and
user, and adjust its response and output accordingly. By tailoring the
display to the permission level of each user, it will be possible to
ensure individuals never see information they are not authorised to
view. This has the added benefit of making it easy for users to access
the data that are of most relevance to their job functions. The idea can
even be taken a step further: instead of making users log on to check
for updates, a well-designed system would issue targeted alerts whenever
data, analyses and reports of relevance are available.
How Sponsors Can Benefit
Patients
already benefit from systems that alert them to upcoming site visits
and other information relating to their participation in a study.
Translating this approach to sponsors will spread the advantages more
broadly. The specifics of how to carry this out are tied to the position
of sponsors in the trial process. Sites oversee patients; CROs oversee
sites; and sponsors oversee the whole operation. As such, sponsors
require a macro-level view of the trial's performance to carry out their
jobs.
Specifically, sponsors need quick and straightforward
ways of monitoring the status and progress of their clinical research
programmes on global, regional and national levels. Currently, clinical
trials are generating these data, but technological shortcomings are
rendering the insights they contain somewhat inaccessible to sponsors.
Opening up the data to them will yield multiple benefits. For example, a
sponsor that can easily pull up data on enrolment and compliance, and
compare them to targets set at the start of the study will have more
productive progress reviews with their CROs.
This workflow is
underpinned by access to real time data analyses on the status of a
clinical trial. For this to work, the system must be able to pull in
data as they are generated and, importantly, very quickly analyse the
information and package it in way that delivers meaningful insights to
sponsors. Without such a rapid system for analysing and visualising
metrics and key performance indicators, sponsors will struggle to
respond to issues quickly enough to have a tangible impact on the
running of their clinical trials.
What CROs Stand to Gain
The
data demands of CROs differ from those of sponsors. While sponsors will
benefit most from a macro-level overview of a study, the position of
CROs in the process makes more granular data of greater use to them. It
is normally CROs, not sponsors, that contract with sites. As such, it is
CROs that need data – preferably packaged into an easily digestible
form – on how a clinical trial is performing on a site-by-site basis.
Real time access to such data can make the difference between a study
hitting its timelines and falling behind.
For CROs, the
criticality of the data derives from their ability to support decisions
that alter the performance of a study. If a CRO can identify which sites
are struggling to enrol patients early in a clinical trial, it can
initiate training programmes and other support actions intended to bring
certain centres up to speed before they start to affect the timely
completion of the study. In parallel, a CRO can spot high-performing
sites, learn what tactics are working for them and transfer the lessons
to other centres. This approach to site management is a better use of
CRO resources.
These immediate, targeted benefits are
complemented by longer-term, broader gains. As well as giving CROs a way
to view the performance of individual studies, technology can provide
an overview of the collective status of multiple clinical trials. Such a
view provides a snapshot of the overall health of the activities being
overseen by a CRO. Retrospective analyses of these activities, both at a
study and CRO-wide level, can uncover learnings that enable CROs to
improve the design of future trials. This can cut the time it takes to
set up a study, and reduce the risk of problems arising once it is live.
Integrated Engagement
The technological
framework outlined above can end the uneven distribution of the benefits
that are unlocked by clinical trial engagement technologies. Over the
past decade, patients have, quite rightly, been the focus of trial
engagement initiatives. Prior to the emergence of mobile engagement
tools, it is patients who were arguably the most unconnected from
studies, despite them being the focus of the whole process. With mobile
devices bridging the gap between participants and clinical trials, the
sector is on a path that will lead to studies becoming ever-more attuned
to the needs of patients.
Now, there is scope to expand
engagement activities to improve the clinical trial experience for other
groups. Like patients, sponsors, CROs and sites can all benefit from
being given the information they need, when they need it. This
information already exists. What was previously lacking was a way to
collate, organise, analyse and visualise the data in ways that meet the
unique needs of each set of organisations. This technological gap has
recently been addressed, positioning the clinical trial sector to gain
from the efficient flow of data to those who need it most.
Once
such technology takes root, it will make the current system – in which
sponsors, CROs and sites are cut off from the insights they need to make
decisions – appear as outmoded as the pre-patient engagement era
appears to us today. The downstream consequences of this advance for all
groups involved in clinical trials are likely to be significant.
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