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International Clinical Trials

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The pressures on sponsors and clinical research organisations (CROs) to demonstrate better health outcomes during clinical trials have never been more intense. Increasingly fierce competition, reduced pipelines, price pressures and rising R&D costs mean the subject of effective patient engagement is becoming ever-more important.

Clinical data from non-compliant or disengaged patients can affect trial outcomes to such an extent that they can make or break a drug candidate. With this in mind, the industry is seeking ways to improve in two critical ways: adherence to medication regimens, including the reduction of patients that are lost-to-follow-up; and ensuring the collection of high-quality, accurate data from patients. Furthermore, given the global nature of today’s clinical trials, increasing efficiencies in data management are critical.

Patient-Centric Approach

Patient adherence to treatment regimes during clinical research is crucial, as straying from a treatment plan can negatively impact outcomes, while also damaging a patient’s long-term health. However, it is estimated that as many as 30 per cent of clinical trials participants do not take their study medication correctly (1).

As a result, the industry is increasingly adopting a more patient-centric approach to engagement, recognising that if patients are supported, higher levels of retention and compliance are achieved. By ensuring that data capture methods fit seamlessly into to the daily lives of patients, not only is the process of reporting data simplified, but the data itself is of better quality.

Everyday Technology

Mobile and digital technology provide effective ways to deliver this approach as everyday technology can be used to capture clinical outcomes right at the point of experience. This can be achieved regardless of who is reporting the outcome (patient, clinician, carer), or what type of data is being captured – whether it be diaries, questionnaires, validated instruments, integration of data from medical devices such as glucometers and spirometers, or any combination of these.

The use of familiar technology enables such data capture services to be deployed on devices that are recognisable to patients and already integrated into their day-to-day lives. Engagement pieces can be built into the heart of a clinical programme alongside the plan for data capture. Including relevant and targeted content, as well as considering how, when and where messages are sent (for example, email versus SMS text, delivered at the most appropriate time of day) can increase compliance, reduce missing data and improve the overall quality of data.

Bring Your Own Device

As the prevalence of connected technology increases around the globe – as of 2013, there are 6.8 billion mobile phone subscriptions (2) – it is logical to utilise this connection with patients to capture data during clinical trials. Using a single platform designed for clinical application and to comply with global data protection regulations, solutions can be tailored according to demographics, geography and different cultures.

Data security and patient anonymity are, as ever, paramount, as is outlining who has access to the data. In addition, whether a trial requires provisioning of locally prevalent devices, or opts to use the patient’s own devices, the interfaces can be validated, retaining optimal familiarity for patients, and reducing logistical complexities for sponsors and CROs.

Moving into the post-approval arena, the use of technology in late phase clinical trials has been criticised as expensive and inefficient. Providing patients with hardware has historically been cost-prohibitive, due to the long timeframes and the large population involved in post-marketing studies.

However, now that the capability exists to recognise the device being used, optimise display accordingly and protect data, a ‘bring-your-own-device’ approach can be implemented to collect patient data. Keeping them engaged in this way is ideally suited to risk evaluation mitigations studies, registries and other long-term observational studies.

There are added benefits too. Patients are motivated to take care of their own devices – for example, ensuring batteries are charged and replacing lost items. Furthermore, this approach reduces data management compared to the previous method of collecting through paper diaries. Finally, motivation and support can be provided through emails and SMS messaging or, in even more cost-effi cient circumstances, in-app notifications which can reduce the number of patients that are lost-to-follow-up during long-term studies.

Managing Trials: Asia

Running clinical trials across multiple regions also poses challenges in ensuring local cultures are taken into account when planning engagement and data capture. The Asia region will be used here to illustrate cultural specifics.

Asia boasts the largest reach of mobile networks throughout the world; even outside of the main established commercial centres of Japan, Shanghai, Singapore and Hong Kong, the region’s technology is advancing at a rapid rate (3). As a result, it can play an important role in patient engagement and adherence to clinical trials.

Engaging in the right manner is vital; knowing when to collect data, share information or prompt a patient requires an understanding of the local population. While the use of technology offers the potential to engage patients and capture data regardless of location, race, age, gender, disability, health literacy or socioeconomic class, sponsors and CROs need to acknowledge the cultural expectations across the region and respond in the correct manner. For example, according to a recent report, only 40 per cent of Japanese mobile users send text messages, preferring instead to send emails – with 54 per cent of the population communicating in this way from their mobile phone.

Mobile Etiquette

There are further issues to consider around mobile and digital etiquette in different locations. In Japan, for example, eating etiquette sees a significantly reduced usage of all services on mobile during evening meal times. Furthermore, in the evenings, the Japanese are most likely to use their mobile phone to listen to music than any other activity (4).

In South Korea, SMS remains by far the most popular mobile activity throughout the day, while gaming and music are the most popular activities during the morning commute, and mobile social networking is most popular during the morning overall. In China, mobile internet usage peaks in the evening, which perhaps indicates that users in the country prefer mobile to fixed line, or simply have less fixed-line access at home. Gaming is the most popular activity in the evening.

All of these variables have to be taken into account when engaging with patients during a clinical trial. Another important consideration is the difference between internet browsers used in different regions around the world.

Provisioning standard devices to all countries included in a global trial could run the risk of alienating patients in many regions who would be unfamiliar with such a device or interface. Provisioning local devices and validating the clinical outcomes assessments using emulators – a tool set that can replicate the technology being used in the local environment – enables the patient-reported outcomes (PROs) to be completed using a familiar browser, and a truly local focus on a global scale can be achieved.

Smarter Interaction

Packaging all of these benefits together illustrates the reach and versatility of mobile PROs in the provision of high-quality patient interaction during clinical research. The isolation of patients can be a challenge, but digital technology offers the utility to share real-time information, reducing this remoteness to achieve heightened patient motivation during trials.

Technological advances allow for smarter interaction between patients, healthcare providers and sponsors, while the accessibility and familiarity of these devices is helping the industry to enhance the way it engages with patients in a cost-effective and secure manner – with solutions that are fully compliant with global data protection and privacy regulations.

As more than 85 per cent of the world’s population now owns a mobile phone, mobile and digital solutions enhance patient engagement, and therefore compliance and retention during clinical trials. This approach also allows large volumes of high-quality patient data to be securely transferred, managed and analysed, and makes the entire process more patient-centric – whatever locale they happen to be in.

The move towards this new way of collecting data from clinical trials has gained traction with the rapid advances of population connectivity over the last few years. The once cutting-edge personal digital assistants and device-specific data collection methods that were only a few years ago met with fervour and enthusiasm, are gradually being pushed aside in favour of more innovative methods, including the use of electronic PROs on web-enabled smartphones and tablet computers.

As the pharmaceutical industry embraces the rise of new media and the ways in which it can be effectively used to engage with patients worldwide, in any language and at any time, the move to utilising digital and mobile platforms in clinical trials is inevitable.

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Tim Davis is CEO and co-founder of Exco InTouch, the leading provider of mobile and digital patient engagement solutions to support clinical, late phase and mHealth programmes. As a wellregarded speaker and subject matter expert in the clinical technology arena, he is best known for championing mobile innovation in clinical and healthcare programmes.
Tim Davis
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