Remote Monitoring methods in Clinical Trials, using wearables and tracking devices in clinical trails, FDA regulations of wearables in clinical trials

Wearable Devices for Remote Monitoring in Clinical Trials

The uptake of remote monitoring is on the increase according to the latest data from GlobalData Healthcare. However, questions remain over how it should be regulated.

The number of studies using remote monitoring methods, including wearables and tracking devices, has jumped from an average of 60 per year between 2010 and 2016, to more than 250 in 2021, according to analysis from Clinical Trials Arena.

Wearables allow data to be collected automatically and digitally – reducing the need for patients to keep manual data records. Remote forms of monitoring also ease the patients’ burden in clinical trials by reducing the number of site visits required.

Wearables also have the advantage of allowing for real-time data collection, and increase the depth and breadth of data gathered. Successful clinical trials rely on rich patient data, and while a site visit may capture a snapshot of the patient’s experience, wearables provide continuous data that can potentially provide new insight to investigators.

However, in order to fully realize the potential of wearables to streamline clinical research, the processes involved in regulation must be simplified. Currently, there is regulatory guidance from the FDA, but it is quite demanding and arduous to navigate.

The future of remote monitoring rests upon increased regulatory guidance. In addition, there must be greater collaboration between device manufacturers, sponsors, and regulators to fully define how and when wearables can be used; they must agree on standardization in terms of use and validation.

About Cromos Pharma

Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management.

Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Türkiye to offer exceptional patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials.

We provide accelerated study start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data.

Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is located in Portland, Oregon, USA and its European HQ is in Dublin, Ireland.

If you have any questions or want to find out more about how Cromos Pharma can support your next clinical program please get in touch with us by emailing inquiry@cromospharma.com.

 

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