How clinical trials benefit from wearables
Published: 03.12.2024
They measure your pulse, count steps and analyze various health data: Wearables such as smartwatches and fitness trackers have long since conquered the everyday lives of many people. However, these devices not only play a role in the leisure sector - they are also increasingly being used in clinical studies to collect more precise and comprehensive data. The ability to monitor patients remotely in particular opens up new opportunities for medical research.
Types and function of wearables
Modern wearables include a variety of devices that use electrodes and sensors to record and analyze various vital signs, either permanently or selectively. They can be roughly divided into two categories:
Medical wearable
Medical wearables have been specially developed for use in health monitoring and therapy support. One example of this is glucose or insulin meters for diabetes patients. These devices enable continuous measurement of blood glucose levels and thus improve therapy. Until now, these have been placed on the patient's skin to analyze the blood together with the insulin depot. New technologies now allow non-invasive blood glucose analysis using light measurements, which offers enormous advantages for digital clinical trials.
Non-medical wearable
Non-medical wearables, such as conventional smartwatches or fitness trackers, support users in their everyday lives and during sport by measuring activity and health data. They help to monitor heart rate, sleep patterns or oxygen saturation. While they are primarily intended for personal health monitoring, many people also use the small devices to send messages or surf the internet.
How do wearables work?
Most devices are connected to an app on a smartphone and transmit their data via Bluetooth. Software then analyzes the collected information and stores it in a cloud. This continuous data collection offers a great opportunity for medical research and enables patient data to be used efficiently in clinical trials.
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What opportunities do wearables offer clinical trials?
More and more people are using a wearable in their everyday lives. A development that can be attributed to the increasing awareness of personal health - this 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 centers, the devices collect all relevant data directly from the patient, no matter where they are. This spatial independence increases the scope of the study, as patient recruitment is no longer tied to a specific location.
Remote monitoring of patients in digital clinical trials
Thanks to wearables, clinical trials can be conducted from any location. Patients no longer have to visit study centers regularly to have their values documented. Instead, the digital devices continuously collect health data and send it to the study management in real time.
This has several advantages:
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Higher patient retention: As the burden on the patient is reduced, more subjects take part in the study and the drop-out rate is reduced.
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Accurate real-time data: Automatic recording minimizes errors as no manual documentation by doctors or patients is required.
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Faster response times: Study physicians can react to changes at an early stage and take medical action if necessary.
Increased efficiency through automated data collection
While traditional clinical studies rely on questionnaires or selective measurements, wearables provide a continuous source of data. This not only improves data quality, but also enables a more precise analysis of the effectiveness of treatments. For trial participants, 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 small devices guarantee a permanent overview of the state of health, and doctors can intervene at any time if participants' values are abnormal.
Further advantages of wearables in clinical trials:
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Reduced time and costs for doctors and patients
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Improved data integrity through continuous measurements
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Increased transparency and better comparability of study results
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Support for preventive medicine through early warning signals
Wearables in clinical trials: The challenges
Despite all the advantages, the use of these technologies is still associated with a number of challenges and issues. One key problem is the varying quality of the measurements. Not every device provides medically reliable data, which makes it difficult to compare study results. Although wearables inform their wearers about their fitness status, it is questionable whether they provide medically reliable measurements. Therefore, not every wearable is automatically suitable and approved for medical use.
In addition, the following questions arise:
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How do study directors and clinicians ensure that patients wear wearables regularly and without interruption or disruption?
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How can standardized data transfer be ensured when differently developed devices are used?
Standardization processes and close collaboration between developers, pharmaceutical companies and clinical researchers are needed to improve the integration of wearables into clinical research.
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Regulatory requirements for wearables in clinical trials
However, wearables used as medical devices are subject to strict regulations, particularly with regard to patient safety. For example, the introduction of wearables in clinical trials requires the cooperation of several interest groups. In the EU and the USA, there are clear regulations for medical wearables that may be used in a study.
To ensure compliance with these regulations, several stakeholders must work closely together:
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Developers and manufacturers of the technologies
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Pharmaceutical companies and study centers/CROs
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Regulatory authorities and ethics committees
The challenge is to optimally integrate this technology into clinical trial structures and services to ensure sustainable and safe use.
Future outlook: Wearables in clinical research
Increasing digitalization and technological progress will continue to drive the use of wearables in clinical studies. Advanced AI models, blockchain technologies to ensure data integrity and the further development of sensor technology promise even more precise and effective use.
Wearables are changing the way clinical trials are conducted. Through continuous data collection, improved patient monitoring and the possibility of remote monitoring, they offer numerous advantages for sponsors, study directors and patients. At the same time, challenges such as data quality, standardization and regulatory requirements must be overcome.
One thing is certain: Wearables will play an increasingly important role in clinical research in the future and help to make studies more efficient, precise and patient-friendly.