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International Clinical Trials

Personal Touch

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.

Indeed, the 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

Globalisation 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 overcome.

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 step.

‘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).


A 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.

Patients 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.

Effective Engagement

Engaging 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.

The move 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.

Driving Cost-Effectiveness

Implementing 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.

Late-Phase Research

In 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 implemented.

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 way.

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.

Scalable Solution

To 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 and geographies.

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.

Simplicity 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.

Progressive Approach

In 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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Judith Teall is Director of Clinical Excellence at Exco InTouch. She has over 20 years of experience in the clinical research area of major pharmaceutical companies in a variety of therapeutic and functional roles, including patient recruitment and engagement. She originally graduated from the Sheffield School of Nursing and spent her early career as a Registered General Nurse. From this multi-faceted background has stemmed a keen interest in the patient-centric approach to all clinical research activities. As a well-regarded speaker and subject matter expert in the clinical research industry, Judith is best known for championing the role of the patient in clinical and healthcare programmes.
Judith Teall
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