This is an extract from an exclusive free whitepaper that explores whether clinical trials are truly patient-centric yet. Download the full report here.
The smartphone and tablet have revolutionized the way that we communicate, play, socialize, exercise, and amuse ourselves. They also dramatically increase our access to information. There are apps that measure anything and everything. Most of us cannot imagine our lives without them. Now it is possible to integrate patients’ phones for more comprehensive data collection as part of a clinical trial.
As of 2016, 87% of those living in developed countries own smartphones. In emerging markets (Africa & southeast Asia primarily) the use is much lower and directly related to income . Smartphones have many built-in sensors that recognize sleep patterns, follow movement, determine position, and measure distance traveled. One of the more tedious aspects of research is data collection. With the recent innovations in the sensors, data can be collected automatically, continuously and sent directly to the research site, making the potential applications almost limitless.
Anticipating this huge untapped market, major technology companies have entered the clinical research arena. The new Apple ResearchKit offers a software platform that allows researchers to create apps to manage data collected via wearable devices and smartphones. Apple is also developing a biometric headphone system to monitor vital signs while the wearer listens to music. Google recently developed a health-tracking wristband for use in clinical trials capable of measuring pulse, heart rhythm, skin temperature, light exposure, and noise levels.
There are numerous advantages to using this technology for patients. It is technology that patients as study participants are familiar with and in the research setting it becomes a data entry point with much more complete data sets, allows the patient to communicate with the research team, the team can send text messages to remind patients of medication and appointments, and obviates the need for the patient to travel to study sites, miss work, etc.
Research sponsors also benefit by having a continuous availability of data, including diaries, rating scales, and questionnaires, all easily completed. This technology saves many trees since all data is computerized. The ability to communicate remotely allows the sponsor to remind the patient of medications and appointments and to deliver motivation and education. Text messaging alone increases adherence to medication from an average of 50% to 67.8%.
Barriers to adoption include HIPAA protection of patient data, the heterogeneity of phone styles and manufacturers (are they or can they be compatible with the software?) and regulatory acceptability. Fortunately, the FDA has given their blessing to “BYOD” (bring your own device).
This extract is part of a whitepaper that asks whether patient-centricity is truly at the core of clinical trials. Download the full whitepaper for free here.