The use of mobile technology in clinical trials is currently a hot topic of discussion across the industry. Advances in technology, both in terms of capability and accessibility, enable mobile and digital devices to be utilised to engage patients and collect their data in clinical research across the globe. Increasingly this approach is being implemented using a bring your own device (BYOD) approach, which not only provides an extremely cost effective means of communicating with and collecting data from patients, but also provides a familiar interface that is maintained by and carried with patients throughout their daily routines.
At the recent MCT Congress – the first conference in Europe solely focused on the use of mobile technology in clinical trials – Leonard Sacks, Heather Stone and Jonathan Schelfhout from the FDA joined a panel discussion to discuss BYOD in clinical research. They recognised the industry is ‘at the threshold of a clinical revolution’ and expressed their support for the movement towards mobile and BYOD in clinical trials, clarifying that BYOD strategies do not contravene 21 CFR Part 11, which had previously been speculated as a barrier to adoption.
Patients are inherently familiar with the user interface, keep the devices recharged and carry devices with them
Since 2004 Exco InTouch has used mobile technology in clinical trials, and in 2008 ran the first BYOD data capture in a clinical trial. Through this experience the company developed the following steps to enable sponsors and contract research organisations (CROs) to integrate a BYOD approach into their clinical research strategy:
1. A true BYOD approach is inclusive, not exclusive
To reach the maximum population the solution must be device independent. For some trials this can be achieved through browser based apps, for others native apps are required to pair with other devices, or to remove connectivity problems that may occur. This requires apps that are approved across operating systems (iOS, Android, Windows) as well as across versions within operating systems.
2. Device independent BYOD builds in usability and familiarity
Through enabling patients to select their own preferred device(s) for communication and data capture, patients are inherently familiar with the user interface, keep the devices recharged (a common issue for provisioned handheld devices) and carry devices with them as part of their daily routine. For many forms of outcomes measures the interface can be tailored to native controls (buttons, slides and date pickers standard to the operating system) to simplify diary or questionnaire completion for patients. Where validated instruments are applied, these can be standardised to meet validation requirements; additionally, device diagnostics can be applied to block use via devices if the screen size is outside the predefined acceptable range (determined during equivalence studies). In addition to these advantages, the use of apps enables updates to be deployed remotely, removing the need for patients to be recalled into site, saving time and effort for both patients and site staff.
3. Build in data protection and data security measures
There is a misconception that provisioned devices are more secure than use of personal devices. This is not true. Best practice is to understand data protection regulations and develop a platform that complies with EU Data Protection, Safe Harbor and HIPAA guidelines. Through ensuring separation of personally identifiable information (PII), the use of data encryption for locally stored data and study databases and the inclusion of permissions for data handling in the ethics/IRB approved consent process, it is possible to build all security and protection controls into software, whether delivered through a provisioned device, or the patient’s own mobile device.
4. Automate the data collection process
When designing the clinical study the range of data capture techniques must be agreed and incorporated into the user interface design. With advances in technology it is increasingly common to incorporate objective data from medical devices, or wearable technology such as activity trackers. The use of mobile in clinical strategies enables this data collection process to be automated, transmitting directly (in real-time) into an app via Bluetooth, removing the requirement for patients to transcribe measures manually. To support this, training should be incorporated into app design to walk patients through the device-pairing process and provide support throughout the trial duration.
5. Incorporate validated instruments into data capture
Until recently the use of validated instruments to assess patient outcomes has been a barrier to adoption of a BYOD approach pre-approval. However, the use of an advanced platform which can identify the device in use can overcome this barrier. To achieve this, an equivalence study should be conducted with the authorisation of the author, to validate the assessment across a range of devices. Once validation is confirmed, specifications can be set to limit completion to devices within screen size boundaries. To implement this sites should run a diagnostic check on the patient’s phone to assess compliance with specifications, meaning that devices only have to be provisioned to a reduced number of patients. Should a patient attempt to access the instrument with a device outside these boundaries, they can be blocked from the instrument and instructed to use an alternative device.
6. Plan ongoing monitoring and support
The use of mobile data capture offers enormous potential to automate and strengthen patient monitoring and support throughout the trial duration. The requirements for each study should be considered during planning, and methods for tracking, monitoring and alerting built in to software design. This BYOD approves a mechanism to create a full audit trail for data capture, identifying how and when data is entered. It enables monitors to track whether patients are using phones, tablets, laptops or other devices such as internet TVs to complete assessments, flagging if a device is changed, identifying whether this meets study constraints and implementing controls if patients attempt to step outside pre-determined boundaries. Connectivity and compliance can be tracked, such that if a patient loses connectivity, or fails to complete assessments, an escalation pathway can be set to send automated alerts, contact patients through alternative means (eg email or text) or flag to sites to make contact with patients.
Mobile technology is increasingly being implemented as a means of communicating in real-time 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 that is being conducted, region and demographic), makes the technology perfectly positioned to integrate into global healthcare markets.
The six factors detailed above enable sponsors and CROs to create an inclusive strategy for data capture, providing a means to collect data using the patients’ own devices. This approach is not only cost effective, but significantly reduces and often removes all need for provisioning of devices for electronic patient reported outcome (ePRO) collection. In addition this secure route to data capture simplifies participation in clinical trials for patients, and provides a valuable support mechanism to improve compliance to study or healthcare programme requirements. As a result, sites are able to focus resources on the small percentage of patients that require additional support, and the need to manually monitor full study populations is removed.
