|International Clinical Trials
| Communication is what makes the 21st century world go round. Our lives
are now dominated by the way in which we interact with the
ever-advancing and accessible personal technology at our fingertips,
such as mobile phones, tablet computers and laptops.
rise in the use of global communications technology – there are an
estimated six billion mobile phone subscriptions worldwide – is changing
the face of clinical trials and how contract research organisations
(CROs) and sponsors approach patient retention and adherence.
Technology to the Rescue
of clinical trials is undoubtedly a challenge. Language barriers,
cultural differences and a lack of access to healthcare professionals
(HCPs) in certain regions present issues that the industry must
But is enough being done to fully support patients on
their journey through the trial? The persistent problem of patient
drop-outs and risk of trial failure suggest improvements are still
needed – and harnessing communications technology is the essential next
‘Engagement’ in clinical trials now goes well beyond simple
reminders to patients. In striving for increased patient adherence to
medication regimes, retention throughout the trial duration and,
ultimately, better patient outcomes, sponsors and CROs are implementing a
more patient-centric approach.
It is known that electronic
patient reported outcome (ePRO) data collection has transformed patient
engagement, but until recently, it was limited to the use of provisioned
devices. Now, the use of device-independent technology has opened the
door to a more cost-effective model: bring your own device (BYOD).
patient-centric approach is vital, and site-patient communication
planning should start with a full understanding of the patient profile.
This should define how messages are designed and delivered for greatest impact, to counteract lost to follow-up or early discontinuations.
have a choice to be part of a clinical trial, so it is often a very
fragile balance – clinical trials rely totally on the goodwill of
patients, so if they do not feel supported or valued in their
experience, it is inevitable that they will disengage. With today’s
complex study designs, and the burden often being passed onto the
patient, it is not always made easy for the individual to succeed and
stay the course.
But with technology playing a huge part in our
lives – some 85 per cent of the global population own a mobile phone,
for instance – mobile and digital solutions are playing an ever-more
important role in increasing patient retention, by capturing data and
enhancing patient engagement in a familiar and non-intrusive way.
in the right manner with the patient is critical; knowing when to
collect data, share information or prompt a patient requires an
understanding of the local population. While technology offers the
potential to engage patients and capture data regardless of location,
race, age, gender, capability, health literacy or socioeconomic class,
sponsors and CROs need to acknowledge cultural expectations throughout
different regions, and respond in the correct way.
towards this new way of collecting data has gained traction over the
last few years. As the pharmaceutical industry embraces the rise of new
media and how it can be effectively harnessed to engage with patients
worldwide, greater utilisation of digital and mobile platforms
throughout the industry is inevitable.
a device-independent approach in clinical trial protocols can deliver
return on investment through a number of avenues. The use of a familiar
and engaging method of capturing data can reduce the number of missing
data-points and thereby increase quality; this, combined with greater
retention of patients, can reduce the need to ‘pad’ the sample size to
minimise the impact of missing data and discontinuations – typically an
extra 10 per cent.
Moreover, in large events-driven outcomes
trials, by retaining the maximum pool of patients in which to observe
events, studies can be brought to an earlier close, reducing their
overall cost and duration.
Further cost saving can be leveraged
by planning across a programme, rather than just for individual studies –
the principles and messages are often largely the same – and can easily
be implemented widely, even if it requires slightly different
messaging, such as for sub-populations or sub-studies.
post-marketing studies, providing patients with hardware for ePRO has
historically been cost-prohibitive due to the associated long duration
and large populations. However, new technology enables secure data
capture from any connected device. By recognising the device being used
and optimising the content accordingly – as well as identifying
personally identifi able information – a BYOD approach can now be safely
This approach not only helps improve the quality
of data capture by fi tting the process seamlessly into patients’ lives,
but it also opens the door to an engagement plan to motivate and
educate patients throughout the process. Whether it is diaries,
questionnaires, validated instruments, integration of data from medical
devices such as glucometers, or any combination of these – device
independence expands the options for capture in a truly cost-effective
Through utilising patients’ own phones, tablets or home
computers, cost-efficient engagement messages can be delivered at key
time-points through a combination of email, SMS messaging and in-app
notifications. Incorporating engagement tools into late-phase planning
can increase data quality, enable quality decision-making for HCPs and
reduce lost to follow-up issues.
optimise late-phase patient engagement, technology solutions need to be
scalable and focus on ease of use for patients and HCPs, to ensure
accurate, secure and timely data capture across all patient demographics
Traditionally, late-phase data collection has
been conducted using paper diaries due to the associated hardware costs
of implementing electronic solutions. However, collecting and
consolidating data this way can be resource-intensive and a burden on
both timescales and budget. In addition, data reconciliation is
near-impossible due to the diffi culty of re-engaging with patients and
the timeframes elapsed between recording and review.
is key. A single system can be used to engage with patients, collect
data and enable real-time data review by all stakeholders. Patient
outcomes can then be integrated into a single data repository which
creates standard reports for speed of access. As a result, physicians
and sponsors can address safety risks as they occur.
summary, including a device-independent approach in clinical research
planning is not just an industry trend, it is vital to the future
success of clinical trials. Such an approach delivers an extremely
cost-effective patient-centric strategy for sponsors and CROs, and also
enhances patient engagement and adherence to medication regimens. This
technology will infl uence the success of clinical trials, both
economically and socially, and is a progressive approach to patient
retention and adherence.
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