$ 8.1 Bn
$ 2.43 Bn
$ 2.51 Bn
Category Intelligence on Wearable Devices (Clinical Trials) covers the following
Macroeconomic and regional trends impacting cost, supply, and other market dynamics, wearable devices market research and wearable devices market news
Mobile Health Technology, though in early stages, has attracted the pharma industry to utilize them in clinical trials for better trial outcomes and also to shorten the trial timeline. In a survey, which included respondents from sponsors, consultants, CROs, academia, and labs said that the ~78 percent of them have been using mHealth in clinical trials for more than a year (Sources: Applied Clinical Trials, SCORR Marketing)
Accuracy, standardization and analysis of wearable-generated data
The data associated with wearables are voluminous. It has always been a challenge for the CROs and sponsors on how to handle wearable-generated data. It is important that the data received should be standardized and ready to be integrated in to the clinical trial platforms and data collected in an uncontrolled research environment should be converted into meaningful outcomes by laying structured guidance/procedures to be clinical trial-compliant
Data Security/Privacy Concerns and misuse
Cisco predicts that there would be 600 million wearables data online, globally by 2020. This demands the regulators and device manufacturers to pack in data security protocols into the wearable devices to prevent the patients from encountering cybersecurity attacks. As these data are stored in clouds they could be retrieved without the knowledge of the user. Activity trackers, are however considered as inoffensive, but the user maybe unaware of how those long-term collected data could be misused by a third-party. E.g., insurance providers, who can either cancel the policy or quote high health insurance price
Reluctance in adoption of wearable devices
Though the use of mobile phones and apps might advance, there will be only less than ten percent of clinical trials that will use wearables by 2017, according to Gartner. Wider adoption of wearables could be a challenge and barriers to recommendation to the patients are:
1) Unavailability of smart phones with all patients
2) Inconsistent device use leading to incomplete data
3) Integration of the wearable data with the existing e-health management systems
4) Reluctance showed by the physicians to adopt this technology as the data collected are large and data analysis is a challenge to them as they don't have time or does not have the skill set
Lack of guidance from FDA to use wearable devices in CTs
With the upsurge in use of wearables for health monitoring and social media for patient recruitment in clinical trials Association of Clinical Research (ACRO) has sked the FDA to update the guidelines for the wearables and softwares, so that the sponsor and CRO can be encouraged to use it.
Data from wearables can be valuable in personalized medicine when combined with the genetic data, aiding to identify right patients for the right treatment at the right time
Precision Medicine Initiative: The Precision Medicine Initiative launched by President Obama valued $215 million (for the fiscal year 2016), out of which, $130 million is allocated to create the database (participant group or cohort) and $5 million to facilitate clinical data inter-operability
The crucial of all the phases in clinical development is Phase-I, as it tests the drug safety on healthy volunteers. Incorporating wearable devices can:
Technology Innovation in Sensors
Wearables will become an essential part of everyday life, like smartphones and mobile apps, as technology becomes more affordable and reachable, paving a path for remote patient monitoring.
Wearable IoT in Healthcare
Wearable devices and apps are powerful tools to save both cost and time at hospitals by providing physicians with an easy track of a patient's condition, thereby allowing them to develop critical insights and provide an advanced diagnosis. Certain wearable devices are capable of measuring ECG samples on a periodic basis, aiding healthcare professionals to monitor the patients virtually and remotely.
GPS Technology in Smartwatches
Technologically advanced wearable devices and smartphones come with gyroscopes, compasses, accelerometers, and motion trackers. This combined data will enable wearable devices to calculate pulse, speed, distance traveled, and total calories burnt. This will further improve the accuracy of measurements and values obtained from wearable devices.
Data collection and Real-World Evidence (RWE)
Wearable devices will enable advanced data collection and the creation of more diverse datasets. This information can be aggregated, linked, and processed by digital marketers to understand key aspects, such as buying habits, location of the target audience, clinical trial-related data, and can be processed to produce key conclusions in the form of RWE.
Healthcare providers can collect data from patients, as well as use wearable technology to keep doctors connected to co-workers and data without the hassle of a pager or phone system.
The boom in wearable technology has been mainly fueled by fitness, such as wearable gadgets’ that monitor your heart rate or track your exercise. These gadgets have been successful because they are helpful to the user and easy to integrate into everyday life.
The market’s growth will be fuelled almost exclusively by activity monitors and wrist-worn fitness trackers. The market is observing the evolution and growing acceptance of wearable injectors emphasizing patient-centric, convenient, cost-effective, and user-friendly wearable drug delivery solutions in-home care settings.
Wearables are used in a widespread way to collect physiological touchpoints, this in turn can be used to monitor a patient's health remotely.
Virtual trials are on the rise, and FDA approved clinical-grade wearables are making it easier by collecting precise physiological measures
A medical device company is collecting data of patients at the risk of Alzheimer's and related disorders, by capturing gait and actigraphy measures. The sensor is present in the insole worn in normal footwear and a wrist-worn device for continuous monitoring. The wearable will also assess the difference between the data collected by the device and the standard function test data
Pharma is becoming more patient-centric and pharma companies are using mobile technology to make clinical development relevant to patient’s experience living with chronic disease
A top pharma company is in collaboration with a few universities, like the University of Rochester, Boston University, and the University of San Diego, and has a wearable motion tracker for a dermatological disease. They have included various measures like tracking of scratching during sleep, frequency, incidence, and duration to give real-world data of the patients.
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