Wearable Technology Enters the Clinic
By: Nigel Whittle
Head of Medical & Healthcare
13th December 2017
Our continuing fascination with electronic gadgets and a growing awareness of health and fitness issues will, undoubtedly, drive huge sales of wearable fitness devices this Christmas. The range of such devices from FitBit, Jawbone, Garmin and the like is continually expanding, as are their capabilities. They can now routinely measure heart rate, blood pressure, step count, sleep quality and temperature, while integration and connection with Bluetooth-enabled smartphones allows further capabilities to monitor and analyse fitness data.
The rising prevalence of lifestyle diseases, such as obesity, has led to an interest from consumers and doctors in using wearables to alleviate these conditions, and also to a growing realisation that they can be valuable in monitoring patients in formal clinical studies. Although most wearables are targeted firmly at the commercial market, many such devices are now being specifically designed with a primary function of medical monitoring in mind.
The distinguishing feature of these devices, apart from the need to manufacture to the appropriate quality standard, is often the incorporation of embedded technology, which can facilitate the secure collection and transfer of large amounts of data wirelessly. This allows health data from the subject to be collected effortlessly in the background, in the ‘real world’, thereby increasing the validity of the data and lowering the impact on both patient and clinical centres.
Pharmaceutical companies are always on the look-out for ways to manage costs to meet the increasing complexity of drug development, and use of wearable devices in clinical trials represents one potential area where savings can be made. Perhaps, unsurprisingly, there are now over 300 clinical studies involving the use of wearable devices for monitoring a range of medical conditions. Wearable devices are arguably most useful in monitoring highly prevalent chronic illnesses such as diabetes, hypertension, congestive heart failure, and chronic obstructive pulmonary disease. But, in principle, wearables can also be used in all diseases where outcomes can be measured in terms of improved vital signs and enhanced movement.
An area that is likely to see a rapid expansion is in neurological conditions such as Parkinson’s Disease and Alzheimer’s Disease, where analysis of gait and movement can provide powerful insights into disease progression. In addition, wearables are also useful in clinical studies where the patient needs to keep a diary, by simplifying the record-taking process, and by providing prompts and reminders to improve compliance with the treatment schedule.
One fascinating development is the recent approval of the Abilify MyCite digital medicine/wearable combination, in which an anti-psychotic medicine is formulated within, in a pill containing a tiny sensor that, after activation by stomach acid, sends a unique identifying signal to a patch worn on the patient’s chest. The patch automatically logs the date and time of the signal and can transmit information via Bluetooth to a paired mobile device. However, a number of commentators have suggested that it is somewhat odd to attempt this medical approach with patients who may suffer from paranoid beliefs and delusions about being spied upon…
The primary benefit of wearable devices is access to real-world, continuous measurement of a patient’s health through unobtrusive tracking during their daily routines.”
With the prospect of developing richer and more complex patient health profiles, the primary benefit of wearable devices is access to real-world, continuous measurement of a patient’s health through unobtrusive tracking during their daily routines. Other benefits include reduced costs for visits to clinical centres, access to a wider pool of geographically dispersed patients, and potentially decreased variability of data – allowing fewer patients to be recruited into the study in order to achieve the required statistical significance.
More speculatively, developments in predictive analytics offer the potential of alerting researchers to damaging side effects (Adverse Events in medical terminology) before they occur, based on data analysed from individuals and patient groups. The continuous collection of data from wearables will undoubtedly provide valuable insights into a patient’s well-being, potentially by associating activity levels or spikes in blood pressure with drug dosing. But the real long-term significance is the opportunity to aggregate and integrate the data into a comprehensive and holistic model of patient well-being, generating new insights into a range of disease states, and suggesting new approaches to treatment.
There are, of course, problems associated with the use of wearable technology in clinical studies. This includes the uncertain regulatory status of the devices themselves, the overwhelming amount of data that will be collected for analysis, and concerns over patient data security and ownership. Moreover, the pharmaceutical industry tends to be a conservative and risk-averse industry, perhaps due to strong regulatory oversight and concerns over potential litigation. As a result, the use of wearable technology to study illnesses and their treatment has arguably lagged behind other industries.
However, this may be set to change as pharma companies start to engage, and more technology companies enter clinical research and drive the use of wearables. As the technology develops, the collection, aggregation, and analysis of data will surely transform our understanding of diseases and treatment options, to the benefit of drug developers and patients alike.
Our continuing fascination with electronic gadgets and a growing awareness of health and fitness issues will, undoubtedly, drive huge sales of wearable fitness devices this Christmas. The range of such devices from FitBit, Jawbone, Garmin and the like is continually expanding, as are their capabilities. They can now routinely measure heart rate, blood pressure, step count, sleep quality and temperature, while integration and connection with Bluetooth-enabled smartphones allows further capabilities to monitor and analyse fitness data.
The rising prevalence of lifestyle diseases, such as obesity, has led to an interest from consumers and doctors in using wearables to alleviate these conditions, and also to a growing realisation that they can be valuable in monitoring patients in formal clinical studies. Although most wearables are targeted firmly at the commercial market, many such devices are now being specifically designed with a primary function of medical monitoring in mind.
The distinguishing feature of these devices, apart from the need to manufacture to the appropriate quality standard, is often the incorporation of embedded technology, which can facilitate the secure collection and transfer of large amounts of data wirelessly. This allows health data from the subject to be collected effortlessly in the background, in the ‘real world’, thereby increasing the validity of the data and lowering the impact on both patient and clinical centres.
Pharmaceutical companies are always on the look-out for ways to manage costs to meet the increasing complexity of drug development, and use of wearable devices in clinical trials represents one potential area where savings can be made. Perhaps, unsurprisingly, there are now over 300 clinical studies involving the use of wearable devices for monitoring a range of medical conditions. Wearable devices are arguably most useful in monitoring highly prevalent chronic illnesses such as diabetes, hypertension, congestive heart failure, and chronic obstructive pulmonary disease. But, in principle, wearables can also be used in all diseases where outcomes can be measured in terms of improved vital signs and enhanced movement.
An area that is likely to see a rapid expansion is in neurological conditions such as Parkinson’s Disease and Alzheimer’s Disease, where analysis of gait and movement can provide powerful insights into disease progression. In addition, wearables are also useful in clinical studies where the patient needs to keep a diary, by simplifying the record-taking process, and by providing prompts and reminders to improve compliance with the treatment schedule.
One fascinating development is the recent approval of the Abilify MyCite digital medicine/wearable combination, in which an anti-psychotic medicine is formulated within, in a pill containing a tiny sensor that, after activation by stomach acid, sends a unique identifying signal to a patch worn on the patient’s chest. The patch automatically logs the date and time of the signal and can transmit information via Bluetooth to a paired mobile device. However, a number of commentators have suggested that it is somewhat odd to attempt this medical approach with patients who may suffer from paranoid beliefs and delusions about being spied upon…
The primary benefit of wearable devices is access to real-world, continuous measurement of a patient’s health through unobtrusive tracking during their daily routines.”
With the prospect of developing richer and more complex patient health profiles, the primary benefit of wearable devices is access to real-world, continuous measurement of a patient’s health through unobtrusive tracking during their daily routines. Other benefits include reduced costs for visits to clinical centres, access to a wider pool of geographically dispersed patients, and potentially decreased variability of data – allowing fewer patients to be recruited into the study in order to achieve the required statistical significance.
More speculatively, developments in predictive analytics offer the potential of alerting researchers to damaging side effects (Adverse Events in medical terminology) before they occur, based on data analysed from individuals and patient groups. The continuous collection of data from wearables will undoubtedly provide valuable insights into a patient’s well-being, potentially by associating activity levels or spikes in blood pressure with drug dosing. But the real long-term significance is the opportunity to aggregate and integrate the data into a comprehensive and holistic model of patient well-being, generating new insights into a range of disease states, and suggesting new approaches to treatment.
There are, of course, problems associated with the use of wearable technology in clinical studies. This includes the uncertain regulatory status of the devices themselves, the overwhelming amount of data that will be collected for analysis, and concerns over patient data security and ownership. Moreover, the pharmaceutical industry tends to be a conservative and risk-averse industry, perhaps due to strong regulatory oversight and concerns over potential litigation. As a result, the use of wearable technology to study illnesses and their treatment has arguably lagged behind other industries.
However, this may be set to change as pharma companies start to engage, and more technology companies enter clinical research and drive the use of wearables. As the technology develops, the collection, aggregation, and analysis of data will surely transform our understanding of diseases and treatment options, to the benefit of drug developers and patients alike.
