Wearables are devices with sensors which can remotely collect important health and fitness related data and send it off to a central database. The use of wearables in clinical trials has seen an increase in recent years, especially with the transition to virtual clinical trials during the COVID-19 pandemic. The popularity of smartwatches, smartphones and fitness trackers has made the accessibility of wearable devices more easy than ever before. Although wearable devices are originally marketed as being ‘lifestyle devices’, their powerful sensors have evolved to contain great potential for the future of clinical trials.
Monitoring is a crucial element of any clinical trial, with The National Statement on Ethical Conduct in Human Research 2007 (updated in 2018) stating that Sponsors, Investigators, institutions and Human Research Ethics Committees (HRECs) have a responsibility to monitor clinical trials. Novotech CRO have partnered with ObvioHealth which allows them to partake in Remote Patient Monitoring (RPM) via a participant dashboard which provides real-time monitoring thanks to wearable devices and smartphones.
The most popular wearable devices include Actigraph, Fitbit, Garmin, Apple watches and Empatica. Wearables often include software which measures:
- Neuroscience (the nervous system)
- Respiratory system
- Sleep length and quality
- Stress levels
- Metabolic conditions (leading to diabetes, heart disease and stroke)
- Rheumatology (rheumatic diseases)
The Benefits of Wearables in Clinical Trials
The benefits of including wearables in clinical trials include:
- Improved decision making: Having data available before participants visit clinical sites allows medical professionals to make faster decisions and provide more accurate alerts about non-compliance when patients aren’t in a clinical setting.
- New hypotheses: Data collection from wearables provides multiple opportunities for further observational studies that have not been possible before. This can lead to new hypotheses for future clinical studies which can be used to improve participant care by providing new treatments and protocols.
- Better overview of health: Participants can receive information that directly relates to their lifestyle and overall health that they may not have been previously aware of.
- Better understanding of a treatment’s efficacy: The collection of data and health outcomes reported by the participants themselves can provide a better understanding of a treatment’s efficacy.
- More accurate data: Sensors in wearables can provide 24/7 data streams on a participant’s health and activity levels. The data is collected in real-time which makes it more accurate and representative than data collected from a doctor’s office.
- Different biomarkers are measured: Wearables can measure the activity, steps, heart rate, sleep, stress, oxygen saturation of the blood and atrial fibrillation of a participant giving physicians and clinical trial staff a thorough overview. These biomarkers have played an important role in medical research.
- Improved engagement: Virtual clinical trials eliminate the need for clinical trial sites and in-person visits which can be a burden for participants (especially for those who have long travel times and who are unwell). The constant travelling can sometimes lead to dropout rates of up to 30% which can increase the cost and length of clinical trials. Virtual clinical trials lowers dropout rates, and improves engagement levels and adherence to protocols.
- Reduced costs: Turning to virtual solutions reduces administrative duties and streamlines data storage which lowers the cost of clinical trials significantly.
The Challenges of Using Wearables in Clinical Trials
Some of the challenges that arise during the use of wearables in clinical trials include:
- Access to raw data: Clinical trial staff don’t have access to the raw data collected by the wearables.
- Large amounts of data: Having access to large amounts of data can be both a challenge and a benefit. It can be a challenge because often there will be data that is not relevant to the clinical trial and it will have to be excluded from the data that is relevant.
- Data security: Sending all medical and personal data online can be a risk in case there is a security breach and the clinical trial central database system is hacked.
- Raw data: Access to raw data from wearable devices can be difficult to collect, and how the data changes after it is transferred from the wearable device can also cause issues.
- Data accuracy: The accuracy of the data collected and whether or not it supports an endpoint is critical.
Guidelines for Wearables in Clinical Trials
There have been a few initiatives which have provided a valuable framework for using wearable devices in clinical trials:
Clinical Trials Transformation Initiative (CTTI)
- Know what the endpoints are going to be and work backwards from there to select wearable devices. This ensures that the right device is chosen and money won’t be wasted.
- From a data collection, analysis and interpretation viewpoint, collecting the data necessary to address the clinical trial endpoints is crucial.
- Communication and transparency with participants regarding safety monitoring is a critical element of the clinical trial.
- Defining and testing processes for installation, operation and maintenance prior to beginning a clinical trial. Have a plan in place in the event of tech failure.
- Data capture should be put in place and practiced throughout the duration of the clinical trial (where source data comes from, how does it move from a wearable device to the central trial database, and source documentation on data and audit trails).
The Critical Path Institute (C-Path) ePro Consortium
- Offers recommendations for using wearable devices in clinical trials.
- Identify a wearable device that’s fit for purpose in measuring the identified endpoints within a clinical trial. Take into consideration these three factors:
- Is the wearable device and sensor safe to use?
- Is the device suitable for the trial objectives and participant population studied?
- Is there enough evidence of data validity and reliability to confirm that the wearable device provides content validity and reliability of assessment?
- Identifies the need for evidence to establish clinical trial endpoints that derive from wearable data (ability to detect change, and the primary, secondary and exploratory endpoints).
Proof of Concepts (POC)
Used by clinical trial Sponsors to test and confirm the feasibility of wearables in clinical trials. Sponsors work alongside device makers to establish endpoint data collection and validation.
This is crucial for getting a validated and verified look at how each wearable device works in clinical trials.
In future, there will be continued health-related and technological advancements, resulting in the evolution of wearable devices designed specifically for the medical and research industries. There will be improvements in battery life, connectivity and security. As well as more advanced sensor modules which will result in more useful data and insightful statistics.
Regulatory authorities will need to keep a balance between regulatory clarity and flexibility so that new technologies will continue to be tested and utilised in the clinical trial process.