How clinical trials benefit from wearables

They measure the pulse, count steps or display messages: More and more people are using wearables such as smartwatches or fitness trackers. Devices that also offer advantages for clinical trials. An overview.

 

Types and function of wearables

Many people are familiar with wearables as smartwatches or fitness trackers that count steps and calories and measure pulse or blood pressure. With the help of electrodes and sensors, these small devices record various vital signs on the wearer's body, either continuously or at specific times.

Medical wearables

Medical wearables support the treatment of diseases and improve the quality of life of people with chronic diseases. Glucose or insulin meters for diabetes patients are an example of this. Up to now, these have been placed on the skin of the patient to analyse the blood along with the insulin depot. But companies are currently developing wearables that measure the blood glucose level through the skin by means of light measurements.

Non-medical wearables

Non-medical wearables, such as smartwatches or fitness trackers, are used to check vital signs during leisure time and sports. In addition, many use the small devices to send messages or surf the internet.

How do wearables work?

Wearables are often connected to an app on the smartphone. The collected data is transferred from the wearable to the smartphone via Bluetooth. An app then evaluates this information and transfers the results to a cloud.

 

What opportunities do wearables offer clinical trials?

More and more people are using wearables in everyday life. This is a development that can be attributed to the increasing awareness of one's own health - which opens up opportunities for sponsors and companies in the pharmaceutical industry.

One of the biggest advantages of wearables in clinical trials is remote patient monitoring. Instead of long patient interviews and visits to study centres, wearables collect all relevant data directly from the patient, no matter where he or she is. This spatial independence increases the reach of the study; patient recruitment no longer takes place at a specific location.

Wearables offer data in real time

Wearables measure the vital signs of their wearers in real time. This means that data no longer has to be documented manually by patients and doctors. The devices transmit the collected information directly to the study centres. For those involved, the study is simple and smooth, the willingness to participate increases and the drop-out rate decreases.

At the same time, doctors can provide better care for patients. The wearables guarantee a permanent overview of the state of health; in the case of abnormal values of participants, doctors can intervene right away.

Other advantages of wearables

• Less effort for doctors and patients, participants save time and costs

• More valid study results thanks to high data integrity

• Patients have a better view of their own values and avoid behaviour that is detrimental to their own health

• Wearables help in preventive medicine by sending alerts when health deteriorates

 

Wearables in clinical trials: the challenges

Despite all the advantages, there are still some challenges and questions associated with the use of wearables in clinical trials:

• How do study directors and medical professionals ensure that patients wear wearables regularly and without interruption or interference?

• How can a uniform data transfer be achieved for differently developed products?

Another obstacle to the use of wearables in clinical trials is the accuracy of the measurements. How accurately data is collected varies from device to device. Wearables inform their wearers about their fitness status, but whether they take medically reliable measurements remains questionable. Therefore, not every wearable is automatically suitable and approved for medical use.

However, wearables used as medical devices are subject to strict regulations, especially regarding patient safety. Thus, the introduction of wearables into clinical trials requires the cooperation of several stakeholders. Developers, CROs, pharmaceutical companies and committees work together to integrate wearables into clinical trials, to digitise them permanently and to make them safer and more efficient.

 

^{Text: Alcedis-Redaktion}