Wearables and e-health devices for clinical studies

The clinical trials industry is changing. As an equipment provider for clinical studies, Clinichain identifies that the industry is operating more remotely, more data-driven, and has become paperless. We experience an increasing amount of studies involving a wearable (wearables) monitoring device and a connected app, through which patients can receive feedback from their researchers and site personnel. The personalized data generated by the app itself is used to read out clinical outcomes. Throughout this innovative approach, the journey from lab to patient will be shortened. This means faster development of new medicines and treatments.

Article Written by: Erik Hoddenbach

Wearables have the potential to overcome several challenges related to clinical trials. They improve execution by increasing patients’ ability to participate, driving patient engagement, and creating more opportunities for decentralized trial sites. Measurements can be done continuously and result in more reliable clinical result outcomes.

 

E-health devices

Clinichain believes that remote measuring will be fundamental in the future of clinical studies and has done much field research on a suitable type of rental solutions for wearable and connected devices. After several years of experience in the clinical study field, we have selected the following wearable and eHealth devices suitable for clinical studies:

  1. Connected digital scales: Over the years we have seen a growing demand from customers in having their digital scales able to connect to real-time statistical process control software and apps. With connected scales, it is possible to perform on-site monitoring of weight remotely.
  2. Fitbits & medical watches: Our clinically validated Fitbits track activity, heart rate, and sleep. Researchers track patients’ step counts as well as standard measures of performance status. For one of the metabolic studies, Patients are monitored during the entire study from a distance. Real-time data captures all the above measurements. These devices help measure performance continuously when patients are away from the clinical sites, resulting in reliable study outcomes.
  3. M-health devices: Patients use mobile phones to acquire data throughout a clinical application. For example, patients enter the level of pain during the studies. This will be read out centrally by the CRO and data manager. With this digital mHealth solution, patients don’t have to fill in paper questionnaires. Questionnaires can be collected centrally and analyzed from a distance.
  4. Wearable glucometers: Wearable glucometers can remotely monitor patients’ blood glucose levels between appointments and site visits. Individual targets can be set for patients, and an automated alert system will let professionals know when deviations occur. Results are ingested in a cloud storage environment by the site’s personnel, benefitting diabetic studies.
  5. Wearable spirometers: With the newly developed spirometers, linked to a smartphone, patients can be measured without cables. The wearable device converts exhaled air into a measurable signal. Afterward, this device is linked to a disease management platform for both the patient and the care provider. Again, the central reading of this respiratory data generates efficiency for the CRO.
  6. Connected blood pressure meter: A blood pressure meter is one of the most traditional clinical study equipment. For clinical trials, we have selected a high-end medical device that measures blood pressure remotely with clinical accuracy around the wrist. All physical and sleep activities are measured at home, which enables continuous monitoring at night. This virtual data is continuously visible and can be read out, resulting in a reduction of clinical site visits.

 

Clinical trial service

Biotech companies are facing more and more global logistics needs and local purchasing challenges for home trials. They need to ensure timely delivery at the homes of the patients. For clinical projects the CRO has a need to rent these wearable devices and let them be picked up after the site closes down, compliant with the Sunshine Act. Timely re-supply service of ancillaries and disposables ensures studies continue smoothly without any delay.

Managing devices for home trials means the calibration process needs to be arranged ahead of deployment. With a sophisticated strategy for calibration exchange services, all on-site devices stay calibrated for the entire study and conform to the quality guidelines.

Tablets and mobile phones are needed globally to perform the clinical application, sites require a local Wi-Fi hotspot or 4G capability. To simplify the process, pre-configuration service will make sure sites receive ready-for-use equipment. For the safety of data integrity and the Sunshine Act, data recovery and disposal service will be needed after site closedown.

Sponsors request flexible and transparent rental solutions for these wearable and clinical devices, to help clinical budgets stay on budget and adapt to early terminations of clinical sites.

Would you like to know how Clinichain can support your studies remotely and digitally? Feel free to contact us for an eHealth device solution and/or global clinical equipment rental options. We look forward to getting in touch!

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