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Clinical trials often place a significant burden on participants, necessitating regular travel to medical facilities, financial obligations, and time away from work, all while participants grapple with the uncertainty of whether they have received an experimental treatment. These challenges can be particularly difficult for specific demographics that are traditionally underrepresented in trials, such as the elderly, children, and individuals who may be cognitively or physically impaired.
Addressing these issues benefits not only patients but also the pharmaceutical companies by reducing dropout rates and enhancing the patient experience. These improvements result in decreased recruitment costs and associated delays. Additionally, increased accessibility expands the pool of potential participants, reduces the incidence of missing data, and bolsters the overall integrity of the clinical trial.
IoT and clinical trials
The Internet of Things (IoT) can be used in clinical trials to increase patient accessibility, often by decentralising the trials. Decentralised clinical trials (DCTs) reduce the number of patient visits through methods including telehealth, healthcare professionals visiting the patient, and IoT devices such as wearables. Wearables contain digital sensors for collecting biometric data including the patient’s heart rate, temperature, blood pressure, galvanic skin response, electrocardiogram (EKG) readings, and brain activity. The data gathered by wearable sensors is transmitted to external devices through connections such as Bluetooth and Wi-Fi. This can then be viewed and analysed by clinical researchers.
Examples of IoT being used in DCTs include remote continuous glucose sensing through wearables by Dexcom’s One+ and Abbott’s FreeStyle Libre. Others include Pfizer using smartwatches and Novartis using digital mobility biomarkers in its studies of LNA043 for knee osteoarthritis. Elsewhere, smart scales have been used in obesity trials.
The benefits of decentralised clinical trials
Roche has produced digital biomarker solutions for both Parkinson’s and Huntington’s disease. These digital biomarkers provide added benefits in Parkinson’s disease where symptoms fluctuate and patients struggle to accurately recall the severity and timing of these. Roche provides solutions to this by using smartphone sensor data to provide more frequent measurements, while reducing the number of clinic visits, improving the quality of the data collected, and reducing the burden on patients. Tests include performing manual dexterity tasks to identify signals of worsening disease such as tremors and slowed movement. Roche’s solutions have been used in-house in Phase II trials, and are now being offered to other companies, such as Neruon23 in its trial of NEU-411.