Digital health, one of the biggest trends in 2015, is essentially the integration of technology in healthcare. There are many emerging solutions offering so much potential to innovate in delivery and streamlining processes in the healthcare industry.
Mobile Health (mHealth) is perhaps the most promising opportunity today. A subset of digital health mHealth encompasses any patient health information or service accessed using mobile technology, such as a smart phone, tablet, or other connected device. mHealth also has a potential role to play in enhancing clinical trial efficiency, by improving outcomes and ultimately reducing the cost. The emergence and popularity of patient-centric applications provides a great opportunity for pharmaceutical manufacturers to engage patients and create a customised, direct relationship with them.
The clinical trial space provides an excellent channel to leverage mobile technologies to increase patient engagement with the end goal of reducing the cost of clinical trials. A clinical trial patient who can see and interact with their own data is not only more engaged but also much more likely to see the trial through. A growing body of evidence demonstrates that patients who are more actively involved in their healthcare experience better health outcomes and incur lower costs. It is therefore clear how valuable patient engagement is to clinical trial outcomes. An example of how mHealth can be integrated in clinical trials is shown in Figure 1:
In addition to faster study execution and cost reduction, the integration of mobile technology in new clinical trial design and business strategy development also holds promise for aligning site and patient needs. In clinical trials that leverage mobile technology, a study could either incorporate a 1) disease specific solution, where the sponsor would provide the wireless tech device to the patient or 2) the “Bring Your Own Device” (BYOD) concept where the study would integrate it with the subjects own equipment; a popular and established concept in workplace IT today.
In reducing cost of clinical trials, the BYOD approach seems to be getting attention in reducing the cost. The assumption is that most people have a smartphone, and that trial subjects can possibly use their own devices, in this case a smartphone in a clinical trial setting. Because a specific device does not have to be purchased for the patient, it follows that clinical trial costs should be lower. Allowing participants to use devices with which they are already familiar improves take-up and response rates to study-related questionnaires. Moreover, the connectivity of such devices affords an opportunity for real-time data collection and reporting. This allows immediate visibility of any anomalous data and can contribute to a reduction in risk.
Whilst a BYOD approach offers many advantages, there are a number of considerations to weigh up. Of course, if not all patients have a device to use, the sponsor could provide it, but the cost of this hybrid approach is expected to be considerably smaller (provided that most clinical trial subjects own a mobile device). The security and compatibility of devices should also be considered carefully. Developing a bespoke medical application could entail an iteration of different versions; for example Apple, Android and Windows, each with different screen formats for mobile and tablet platforms. Compared to a dedicated device, the development efforts needed to maintain and support the whole spectrum of consumer technology could prove considerable.
Since clinical trials contribute the biggest cost percentage in drug development, reducing the cost of clinical trials will ultimately reduce the cost of medications for patients. Irrespective of who provides the device, mHealth opens many opportunities for improving clinical trials provided the concerns are overcome..
To capture mHealth’s full potential, industry stakeholders will need to act in a coordinated fashion to redesign their approach in streamlining the clinical trial process. Working with a trusted developer like FirstApp that has the experience and capability in medical deployment is also key to a successful outcome in mHealth.
Check out the 2015 edition of the Journal of Clinical Trials to read more of the article.
Published by Sarah Iqbal