COVID-19: Considerations and Implications for Digital Biomarkers in Clinical Trials

The use of remote digital measures — sensors, wearables, and other non-invasive remote measurement tools — is a key component of how researchers will respond to the COVID-19 pandemic. The FDA has issued two guidance documents in the space of one week — an unprecedented regulatory response. Adopting some elements of the FDA recommendations — remote monitoring, virtual labs, at-home assessments — will require technology tools already designed as fit-for-purpose clinical trial tools. The agency has detailed non-invasive remote monitoring tools that sponsor companies should be considering, such as devices for remote respiratory assessments, temperature monitoring, and pulse oximetry measurements.

The decision-making process for implementing a digital measure, as either an endpoint or a monitoring tool, into a clinical trial is complex. Issues regarding device selection, patient compliance, and clinical utility should all be considered. Designing a statistical analysis plan to convert continuous monitoring data and big data sets into usable clinical information requires careful planning and an understanding of how wearable data is translated into clinically meaningful information.

In this webinar, the speakers will review:

• The current regulatory environment, including guidance documents issued by the FDA and EMA on preserving the integrity of clinical trials while balancing the safety concerns associated with social distancing and the COVID pandemic

• Considerations when adding digital measures to your clinical trial

• Evaluation criteria when choosing a wearable or sensor to use in your trial

• What to consider for remote patient monitoring in your study

Speakers:

• John Wagner, MD, PhD, Partner, Foresite Capital

• Elena Izmailova, CSO, Koneksa Health

• Andy Coravos, Digital Medicine Society and CEO of Elektra Labs

References:

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

FDA Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency

https://www.fda.gov/media/136290/download

EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

UK GLPMA Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)

https://www.gov.uk/guidance/guidance-for-good-laboratory-practice-glp-facilities-in-relation-to-coronavirus-covid-19