Clinical Wearables

Clinical Wearables Global Market Outlook:

Market Growth:

Expected to grow at a CAGR of 20-21 percentfrom 2020 to 2025
Market Value in 2020E: $18.4 Billion

Market Drivers:

• To address patient recruitment challenges
• Remote monitoring of patients

Industry Trends

• Wireless BSN technology: A mobile physiological monitoring system, which is able to continuously monitor the patient’s heart beat, blood pressure, and other critical parameters in the hospital. The system is able to carry out a long-tem monitoring on patient’s condition

• Data collected from wearables is used to understand buying habits, location of target audience, clinical trial-related data, thereby producing useful conclusions in the form of Real- world evidence Patient adherence Real-time data capture to amend clinical trial design, precision medicine

Challenges in Using Wearables

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 and sold to third party. User data like location, email, age or sex that is registered on the wearable’s app poses a huge threat to the users.
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) Device used inconsistently hence 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
5) During clinical trials asking the patient to charge the device or manage the uploads

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 asked the FDA to update the guidelines for the wearables and softwares, so that the sponsor and CRO can be encouraged to use it.
• Issue a public statement for the use of new technologies in a clinical trial conduct
• To analyze the barriers and benefits with the help of the industry (pharma, CRO, patients, and technology providers)

• Provide clear guidance documents for use of tech-driven solutions in terms of data security and monitoring parameters/requirements
• Proving the FDA that a clinical trial will measure RWD that corresponds to patient outcome without raw data is difficult