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International Clinical Trials

Get Personal

It is widely recognised that lack of patient engagement can have a major impact on clinical trials. A variety of concerns are associated with capturing data from patients who do not follow study protocols, such as inaccuracy in reporting, missing information and loss of interest in further participation – all of which can cause inconsistencies in findings and, ultimately, a trial’s failure.

In order to keep patients engaged in a study over long periods of time, pharmaceutical companies need to first understand their needs and expectations, as well as making sure that trial participation fits into their daily lives.

A patient-centric approach can be paramount to the success of a trial; however, engagement should be more than simply giving reminders to participants. Instead, they should be provided with the most appropriate technology and features which not only integrate seamlessly into their daily routines, but also make their involvement in a study enjoyable. Putting the patient at the centre of a trial’s design may reduce the probability of its failure and can significantly improve both the quality and accessibility of data collection.

Going Mobile

How, then, to ensure that trials avoid failure through patient neglect or apathy? Traditionally, data collection was conducted using paper diaries, due to the associated hardware costs of implementing electronic solutions. But 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 because of the difficulty of re-engaging with participants and the timeframes that elapse between recording and review.

The patient-driven approach increasingly being adopted by the clinical research industry recognises that, if they are supported throughout a study, higher levels of compliance and retention can be achieved (1). Indeed, listening to the patient during drug development and partnering throughout their clinical trial experience – together with simplifying methods to capture and report patient data – is now seen as vital to pharmaceutical R&D success.

Sponsors and CROs have demonstrated a growing desire to simplify clinical data collection by implementing innovative solutions that provide greater access, in real-time, to better quality data in a more cost-effective way (1,2) – while, in parallel, helping to facilitate continuous patient engagement for the duration of the trial (3,4).

Using mobile solutions, each study can be designed to include a relevant, tailored communication plan. Patients can therefore be prompted to take medication, record data and attend site visits; but additionally, through the inclusion of timely and relevant educational and informational messages, can be better engaged throughout.

This is not the future – mobile technology is now being implemented as a means of communicating directly with patients across broad demographics and multiple widespread geographic locations in clinical trials. Simplicity is the 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 instant access. As a result, physicians and sponsors can address safety risks as they occur.

Patient Reporting

The rise of electronic clinical outcome assessments (eCOA) – specifically, electronic patient-reported outcome tools implemented through everyday mobile technology – has transformed how patients can be engaged during a trial. Information can be presented in a way they understand, whether that be through SMS messaging, emails or in-app notifications. This now allows sponsors to incorporate a range of reminder, educational and motivational interventions within study protocols, where previously patients would have typically been left with no support between site visits.

In addition, sponsors are able to monitor safety, manage compliance – including visit attendance, medication, correct preparation for procedures and home-based actions – and closely ensure patient retention throughout the study period. This has not only made trials an easier and more useful experience for patients, but has also enabled researchers to collect and process fuller data quickly, accurately and reliably (5). Moreover, sites can follow up with participants if the data is not being entered in the correct manner, rather than waiting for a site visit.

Device Inclusive

The revolution in personal mobile adoption and advances in wireless data exchange technology offer alternative methods of data collection that can align with the needs of the target patient population, including the device provisioning model, as well as utilising participants' own devices. With clinical trials now commonly being conducted on a global scale, increasing efficiencies in data management is critical, and a device-inclusive approach can deliver return on investment through a number of avenues.

'Bring your own device' offers the eCOA market true scalability, and has the potential to greatly reduce the considerable cost and logistical effort of providing and maintaining traditional electronic patient-reported outcome (ePRO) devices for all those participating in studies. However, provisioning may be required; for example, when a validated instrument is being used to assess primary outcomes, or where Bluetooth® integration with next-generation home monitoring devices is included. Selection of simple smartphone or tablets can provide a cost-effective solution, while maintaining all the benefits of mobile ePRO. Furthermore, the use of regional devices can reduce the logistical complexity of device distribution and further enhance familiarity for patients.

Irrespective of which model is used, the device-inclusive approach can ensure that the technology for capturing and disseminating clinical assessments is both practical and effective in addressing protocol requirements – as well as being engaging and convenient for study participants.

Quality and Time

The use of a familiar and engaging method of data capture can reduce missing data-points and thereby increase quality; this, combined with greater retention of patients, can reduce the need to ‘pad’ the sample size, specifically to minimise the impact of missing data and discontinuations – typically an extra 10%.

Furthermore, 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. In a recent cardiovascular outcome event monitoring study, for instance, a mobile communication service was included to help keep in contact with patients between visits, with a view to increasing the likelihood of patient reporting if and when an event occurred. The use of this mobile service provided a 5% increase in visit compliance and a 4.5% reduction in early patient withdrawal, compared to those not using the service. In a study of 13,000 patients, it is estimated that if used across the entire trial, this would have equated to a four-month earlier finish – resulting in over $14 million savings for the sponsor.

Access to Results

If a trial is to be successful, those taking part need to feel appreciated and connected to the outcomes – as well as how it might help the wider world population. Abandonment is a common complaint within the clinical trial patient community, and so it is not just during the study that they need to feel engaged and wanted, but also when it ends. Delivering a rounded experience to patients is one of the key ways of boosting enrolment in any future trials.

A 2008 literature review of 15 separate studies found that some 90% of participants wanted to be told the results of their trial (6). Looking across studies that assessed the psychological impact of receiving the results, both benefits and consequences were found; and, as the authors noted, “the vast majority of participants reported feeling that it was important to receive study results even if they experienced negative emotions”.

At the same time, there is a growing drive in both the EU and US to allow trial patients access to their own data, so they can see physical evidence of their own contribution to the outcome of the study and become part of the wider drug development story.

However, one of the easiest ways to ensure patients feel wanted and engaged is to simply thank them for their time and efforts. Throughout a trial, they can often feel they are at the bottom of the 'food chain'. Appreciating their participation and involvement can have a substantial effect on morale, and affect their decision on whether or not to enrol in another research study.

Universal Tool

To ensure that clinical trials do not fail, sponsors and CROs must look to the drivers of engaging with patients, as well as their needs, and then deploy technology to deliver these through an easily identifiable interface – rather than making patients feel constrained by a specific technology.

Mobile technology is increasingly being implemented as a means of communicating directly with patients across broad demographics and multiple locations in both clinical studies and healthcare programmes. The familiarity and universal nature of mobile devices – and the ability to select the right tool according to the type of study being conducted, the region and demographic – means the technology can be smoothly integrated into global markets.

The use of mobile technology in clinical trials is no longer a distant dream, nor is it a curio or fad; CROs and global health organisations are actively searching for opportunities to incorporate mobile solutions into their initiatives to increase the probability of success.

1. Donahue M and Henderson L, Pfizer’s REMOTE virtual experience, Applied Clinical Trials, 2012. Visit:
2. inVentiv Health Clinical acquires equity stake in Mytrus, CenterWatch, 2013. Visit:
3. Petrie K et al, A text message programme designed to modify patients’ illness and treatment beliefs improves self-reported adherence to asthma preventer medication, British Journal of Health Psychology 17: pp74-84, February 2012
4. Anderson-Foster DL, Global issues in patient recruitment and retention, CenterWatch: pp133-146, June 2012
5. Bolling J, A patient-centric approach to adherence, Journal of Patient Compliance 1(1): pp28-31, 2012
6. Shalowitz D and Miller F, PLoS Medicine 5(5): pp714-720, 2008

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Tim Davis is Chief Executive Officer and Founder of Exco InTouch, a leading provider of digital patient engagement and data capture solutions for clinical research and healthcare providers. A respected clinical technology subject-matter expert, Tim has been recognised through many accolades, including the PharmaVOICE 100 annual list of the most influential people in life sciences, for his vision to utilise mobile technology to engage patients during clinical studies and real-world healthcare programmes.
Tim Davis
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