Remote clinical trials are especially important in light of the COVID-19 pandemic, and the U.S. Food & Drug Administration has issued guidance for clinical trials during this time. On March 24, a NASEM workshop on “The Role of Digital Health Technologies in Drug Development” covered these issues, and included Koneksa CEO Chris Benko as an invited speaker.

In discussing “Digital Tools for Recruitment and Safety Trials,” Chris was joined by industry colleagues from CDER, Duke, Otsuka, and Ciitizen Corporation.

He covered the ability of digital technologies to provide continuous data streams and help researchers understand the impact of treatments on real-world activity, in contrast to the extremely controlled circumstances of many early-stage clinical trials. Additionally, he pointed out the value of digital biomarkers in helping drug developers make efficient decisions earlier.

The workshop was held by the National Association of Sciences, Engineering & Medicine (NASEM)’s Health & Medicine Division, as part of their Forum on Drug Discovery, Development, and Translation, with the Roundtable on Genomics and Precision Health.

You can read the paper Chris referenced in his talk, “ ‘In-House’ Data on the Outside – A Mobile Health Approach”, which was published in the January 2020 issue of the ASCPT journal.

While the workshop recording is not yet available, the agenda and briefing book are available here.