Can Wearable Technology Allow For a Better Health Outcome In Clinical Trials by 2025?
Over the last decade, wearable technology has become a fixture within the consumer market. Brands such as Apple and Fitbit have invested heavily to lead this consumer subcategory in sales globally[1]. In short amount of time, there has been a dramatic increase in the number connected wearable devices worldwide, with an estimate of one billion devices by 2021[2].
The innovation in smart technology has provided consumers with unprecedented real-time data regarding their health and daily activity[3,4,5]. From a healthcare perspective, the functionality of these devices allows for patient behaviours, to be tracked with ease and moderate reliability[3,4,5]. Wearables are incorporating more sensors than ever before, measuring ones’ heart rate, blood pressure, cholesterol, galvanic skin response, oxygen saturation along with fitness and sleep information[3,4,5].
As a result of the foregoing, it is evident that wearables have provided clinicians and healthcare professionals with a remarkable opportunity to measure biomarkers digitally, in real-time and remotely providing unique insights into the long-term real-world impact of therapies and treatments[4,5]. Digital Biomarkers are consumer-generated physiological and behavioral measures collected through connected digital tools that can be used to explain, influence and/or predict health-related outcomes including but not limited to predicting a patient’s response to a drug through one’s fitness behaviours (e.g. physical activity, heart rate)[4,5]. Through the ability of wearables to collect real-time continuous data, this has allowed them to make its mark into the clinical trial space. Wearables offer the opportunity to collect data measurements outside of the clinical environment in order to provide an understanding of external factors that can influence one’s health and/or disease compared to a single behavioral questionnaire/test conducted during a site visit[5].
It goes without stating that the quality and efficacy of wearable technology varies from product to product[3,4,6]. As large corporations continue to make significant investments into this market, sensor technologies are poised to evolve, improving reliability and functionality[3,4,6]. Continued improvement in wearable technology breeds confidence within the healthcare industry as professionals have begun to embrace this data collection methodology, using the personal health indicators in a patient’s treatment related decision.
Collecting health related data has been a difficult proposition for healthcare professionals, whether it has regarded prescribing the continuous wear of a clunky heart rate monitor or the pain associated with undergoing constant glucose testing for diabetics. Wearable technology has reversed this concept with innovation, aesthetics, and functionality. As a result, a significant share of the population has invested into purchasing wearable technology of some sort. Advertising and marketing campaigns from big corporations such as Apple have normalized the attaining better health and wellness through the use of wearable technology products[7]. This has driven the average person to track their health data and become more health conscience, all with the ideal that it will lead to long-term health improvements[8].
Although in the past the adoption of wearables has been slow, the pandemic has certainly accelerated the adoption of collecting data remotely through digital tools and technologies within the healthcare industry[10,11]. This shift has impacted the clinical trial space where there is movement away from the “traditional” approach of conducting clinical trials through episodic, insensitive and subjective assessments taken during a doctor’s visit towards a remote approach; focused on collecting real-time, continuous, and objective, data[10,11]. This results in a more patient-centric approach, with an emphasis on how factors outside a doctor’s visit can impact a patient’s response to a drug or their quality of life, providing healthcare professionals and patients a better understanding of a disease/health[10,11].
“The COVID-19 pandemic has created a technological revolution that was never expected. This digital change will allow for a greater acceptance of wearable technology into healthcare and the clinical trial space, however, time is needed to figure out how this is all going to work”.
Wearable Technology That Can Generate Health Data Is On The Rise
The wearable technology market size was valued at 32.63 billion in 2019 and is expected to have a compound annual growth rate of 16% in the next 7 years[2]. With this growth rate, wearable technology has expanded to provide for customized products for various disease areas such as cardiology, obesity, chronic diseases[2]. The wrist-wear produce segment has expected to lead within this market in the years to come as it accounted for more than 45% of revenue in 2019[2]. Inherently with continuous production and purchase of these wearable technology products, the accumulation of personal data cannot be ignored. As we incorporate more wearables to measure and collect real-world longitudinal data, the amount of data being analyzed will continue to grow alongside with the development of AI and machine learning software’s. The global big data market size is expected to grow 10.6% by 2025 with 229.4 billion dollars[11].
Adoption of Wearables In Clinical Trials is Increasing Quickly
The potential of wearables in clinical trials has not gone unnoticed. There has been over 1400 clinical trials that have incorporated wearable devices, with 540 being completed and that number is likely rising as the healthcare industry increasingly conducts trials virtually, and gathers data remotely, in response to COVID-19[12].
Most of the data that has been collected using this technology has focused on activity (step count, calories burned) with more recent trials utilizing wearables to collect biometric data including physiological parameters (ex. Heart rate, ECG). Majority of these trials have utilized common consumer wearables including: Actigraphy, Fitbit, Garmin, Apple, and Empatica[12].
Of the clinical trials that have used and are using wearables, Cardiology was the top therapeutic area followed by metabolic disorders (diabetes and obesity), respiratory, and neuroscience related disorders[12]. Though less than 2% of trials have incorporated wearables, it is estimated that 70% of clinical trials will be incorporating such technology by 2025[12].
Regulation For Wearables
When considering the adoption and use of a wearable technology, it is important to understand the difference between device clearance for the purpose of legal marketing as a medical device and a tool for data collection within the context of human research[3,10,13].
The majority of common consumer wearable technologies, including Apple and Fitbit, were originally built for health and wellness purposes and marketed directly to consumers; they were not regulated by the FDA[3,10,13]. If a device has an intended use in diagnosis, prevention, cure or mitigation of a disease, in either humans or other animals, there will need to be FDA approval[3,10,13]. This Approval, within the United States, is obtained through the FDA 510(K) Pathway[3,10,13]. When a device goes through this pathway, they will need to prove that their device is substantially equivalent to a predicate, an already legally approved marketed device which often tends to be similarly engineered[3,10,13]. Under the FDA’s assessment, indications and intended use are the primary considerations[3,10,13]. Devices that are not regulated by the FDA can still be used in clinical trials[3,10,13]. However, the device used will need to show that it is analytically and clinically validated[ 3,10,13].
Barriers To Adoption for Wearables In Clinical Trials
“Wearables are being greatly considered as a way to track various outcomes and health-related parameters as they provide a huge benefit in capturing real-time data. There are many benefits to any new technology or any new development but at the end of the day we cannot forget about who is going to pay”
“The data being collected by these technologies will need to be secured and therefore we have to consider the infrastructure to be set in place to deal with privacy, compliance, and accuracy of the data. The industry has now begun to focus on these particular aspects”.
- Cost: Adding wearables to a clinical trial has the potential to raise costs depending on the wearable used, the type of data being collected, the number of participants and the infrastructure set in place. On average, a wearable is expected to cost one thousand dollars per participant[3,9,10]. Typically, a clinical trial often pays for the devices, however as the cost of the device increases as innovation changes, will this influence the number of participants a clinical trial will then have? This therefore brings into question the feasibility of these studies in the future.
- Adherence Rate: With adding a wearable, it is also important to consider the adherence rates of patients[3,9,10]. Will the patient wear the device? More often then not studies have reported that majority of patients have adhered to the device however, there tend to be a few participants that do not follow. This will influence both the amount of data being collected as well as the validity of the data. If patients are being enrolled in a study and they are not adhering to wearing the device, then how can we trust or use their data to draw conclusions? The adherence rate of a wearable is dependent upon the individual wearing the device. Certain limitations can include age of patients and limiations from one’s disorder (e.g. Dementia, Alzheimer’s).
- Data Infrastructure and Privacy: Another barrier to adoption to consider is if there is an infrastructure in place that allows the data from the device to be transferred to either a cloud or a trial database[3,9,10]. It is essential with collecting this amount of data that an infrastructure is set in place however, the processing and analysis of the data can also drive up the costs of clinical trials. The market has seen an increase in the number of investments being made in developing infrastructure for data to be collected remotely and housed for clinical trials and this has been seen for various disease areas including oncology.
“With patient data being monitored, we have to also think about security purposes. Data being collected and the infrastructure in place needs to be secured and protected. Patients are an important part of the clinical trials, privacy will always be a concern and patients will have to decide how comfortable they are sharing personal information with those involved in clinical trials”.
Can Wearable Technology Help Predict Long Term Outcomes In Clinical Trials?
Wearables offer the ability to collect patient data through measuring a variety of different health-related parameters. As time goes on, many users are becoming more health conscious and wanting to be informed about their health. The next frontier for wearables regards whether the technology can keep an individual accountable and thus provide insights into an individual’s long-term health outcomes and what that would look like from a user and clinician perspective for a specific disease area.
“With the rapid advancement in technology over the last decade, and with the direction in which it is going, wearables will be able to predict long term health outcomes. With that being said, the extent of metrics measured are currently simple and few, but it is certainly possible to have wearables track clinical participants health outcomes and potentially play a role in their health long-term”.
In addition, experts have also expressed:
“There is always a leap of faith for predicting how someone will respond long term, there is no way to know for sure without testing it. It is also important to keep in mind that after the trial is over, will this influence a patient’s health outcomes. Will the patient be able to afford this device after the trial? At the end of the day, our patients are our priority, if they have been relying on wearables to motivate them to improve their health for the length of the trial, will their health begin to decline outside of the trial as they might no longer be using this device. This becomes a bit tricky as many patients, depending on the clinical trial and the disease area are often very ill, and might not have enough money to pay for the device outside of the trial.”
Disease Areas That Can Benefit From Wearables Prediciting Health Outcomes
- Epilepsy
Epilepsy is a chronic neurological disorder in which abnormal brain actitivity within patients results in uncontrollable seizures. [14]. Epileptic patients often experience discomfort when experiencing seizures but it can also result in harm as many often fall during this event and injure themselves. [14]. Recent evidence has shown that epilepsy is not properly controlled by current medications which has resulted in 30% of epilepsy cases to be non responders. Therefore, there is a medical need for an accurate and easy to use seizure predicting device to help improve the quality of life of these patients [14]. Wearable technologies address this need and are currently being used to predict seizures before they happen, influencing the quality of life of epileptic patients which can predict an upcoming seizure and allow them to take actions to prevent injuries[15].
“Expert Opinion-Wearable technologies are now being considered to be included in trials for new anti-seizure drugs as well as for drug-resistant epileptic patients. Typically, seizure trials ask patients to fill out a diary to track when they are having seizures and their frequency. These health-related parameters are often looked at to give an idea of how well the medication is working, if at all”.
Predicting Seizures Before They Happen: Embrace
Embrace, Empatica’s smartwatch is the first of it’s kind to be approved by the FDA[15,16]. It is focused on becoming a valuable tool in managing epilepsy through prediction and improving the quality of life of patients[15,16]. Currently, this smartwatch measures the skins electrodermal activity which is an indicator of neural activity and stress. During an seizure, the conductivity of one’s skin increases during sweating, which has been associated with the onset of a seizure[15,16]. The device is able to pick up on this conductivity, as it has accelerometers embedded which is able to detect long-term changes in skin temperature. In addition, the smartwatch also has gyroscopes, which is able to notify if an individual has infact fallen. Along with the smartwatch is an app which is able to track seizures as well as activity and sleep levels[15,16].
“Expert Opinion: By allowing a wearable device to monitor seizure activity can allow for the patient to prepare themselves in order to make sure they are sitting down and are not in any immediate danger if they need to drop to the ground while the seizure happens. This will ultimately impact their long-term health as this can result in less injuries and therefore impact their physical and mental quality of life.”
This smartwatch has been tested in clinical trials. In 135 epileptic patients, their seizure activity was monitored through the wearing of the embrace device and it was compared to a video-EEG . In over 6,530 hours of monitoring, the Embrace watch detected 100% of seizures- exactly the same rate as the video-EEG device, which if often only used for long-term monitoring if the patient is hospitalized[15,16].
Currently, Empatica is refining it’s smartwatch device through continuous user feedback and results from clinical trials. Their ultimate goal is to build a device thats capable of predicting when a seizure will happen and improve one’s long term health[15,16].
“User Commentary: I would happily wear a device that was able to predict and inform me before I have a seizure. Often, I have found myself in the shower or out at a restaurant where I would suddenly experience a seizure. This has influenced my quality of life as I am afraid of going anywhere or being near objects as this has resulted in injuries in the past”.
2. Oncology
There have been three main health outcomes that are often assessed when it comes to clinical trials in oncology patients[17,18,19]. Quality of life, survival, and treatment progression have been the main health outcomes that have been measured and evaluated, providing an indication of a patient’s response to a treatment[17,18,19]. Often, these health outcomes are measured through various questionnaires which are self-reported and behavioural tests which are conducted at a specific site visit, capturing data at a single time point[17,18,19]. Due to this nature, many trials have found that the reporting and evaluation of health outcomes in oncology patients is often limited and not accurate and the health status of the patient may be misinterpreted, which could influence the evidence provided of a cancer drug working or not and if the patient is in fact improving[17,18,19]. Therefore, the use of wearable technology may be an option to capture real-time, objective continuous data and use such data to provide insights into a patient’s health outcome.
Emerging data from various clinical studies has shown that data measured and collected from wearable devices can positively impact outcomes for a patient with cancer[18,19,20]. These studies will be discussed below. Through patient monitoring of physical activity levels, heart rate or nutritional uptake, such data can help inform about treatment decisions and for appropriate medical intervention.
“Patients that often take part in oncology trials are very sick. Often the last thing they want to do its recall how they felt or fill out a questionaire about their health. Wearable technology offers a benefit to these patients and also to the healthcare practitioners as real-time data is able to be collected objectively and patients are able to be more informed about their health, which can play a role in their quality of life”
Clinical evidence has shown that physical activity is associated with increased quality of life and self-care in cancer patients that used consumer wearable, Fitbit to track health-related parameters such as sleep, steps taken and heart rate[17,18,19,20]. It was found that the more active the patient was over the course of the trial, resulted in a positive course of disease with a lower risk of hospitalizations, reduced adverse events, and increased survival [17,18,19]. In addition, a study on 37 advanced cancer patients found that a higher daily step count using Fitbit was also associated with reduced hospitalization and death [17,18,19]. Additionally, Garmin smart watch was used to measure activity levels during outpatient chemoradiation therapy. It was found that lower levels of activity were associated with greater hospitalization risk, lower likelihood of completing treatment without delays and shorter survival [17,18,19].
Currently, wearable devices are being used to measure various health related parameters in cancer trials and has the potential in the next 10 years to inform on what interventions will look like across different stages of cancer, how treatment will differ among patient populations, and how patients will be able to function after treatment and beyond.
Predicting Health Outcomes: Fitbit
Net Worth: 2.1 billion, acquired by Google
Value Proposition: focused on tracking health-related parameters through design and convenience
As one of the leading consumer wearable technology brands, Fitbit cannot be ignored as one of the best in class examples in capturing real-time health related data and providing evidence in predicting a patient’s health outcomes. Within this year alone, there has been countless amounts of use cases in which this device has shown its ability to complete with their competitors.
Early this year, Fitbit was able to detect COVID-19 in patients before they experience symptoms[19,20,21]. With the collection of patient data, they have begun working on developing a machine learning algorithm to be able to identify early signs of disease and potentially prevent its spread through early detection[19,20,21]. Preliminary findings have also shown that Fitbit was also able to use its wearable technology to measure health-related parameters such as sleep, heart rate and activity in order to develop an algorithm to predict flu outbreaks[19,20]. The reliability of this technology has been acknowledged and applied to one of the most stringent fields: the army. It has recently been announced that Fitbit will begin a study with Northwell Health’s Feinstein Institutes for medical Research to further advance its early detection algorithm[19,20,21]. Its watch will send notifications to employees that exhibit early signs of infection and prompt them to get tested[19,20,21]. Wearable devices such as Fitbits are providing a window to information that even a few years ago we wouldn’t have had access to.
Final Remarks
The healthcare field is rapidly evolving with the advancement of wearable technologies that are helping in improving patient health. As the healthcare industry is moving towards becoming patient centric, patients are now more than ever wanting to be informed about their health and how they can improve it. It is positive that this trend will continue to improve and grow, however there is no clear forecast of the exact growth of wearable technology in clinical trials nor its impact. There are promising technologies that can help patients be more informed on their health and also provide healthcare professionals more information about the health of their patients in order to make better decisions regarding treatment. However, in terms of the impact of clinical trials and its’s adoption with wearables, there is still a long way to go. There are many concerns that need to be addressed such as the infrastructure that will be housing data from participants within trials and the algorithms being used to ultimatley provide evidence of prediction of health outcomes. In addition, patient privacy will always be a concern. As an industry, we are moving towards the right direction, but the author believes that we cannot rely one hundred percent on the data wearable technologies provide. Healthcare professionals and patients can learn from these metrics and then should utilize them to make informed decisions.
References
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