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Decentralized clinical trials

A framework for “direct-to-patient,” “remote,” “site-less,” and “virtual” clinical research

What is a decentralized clinical trial (DCT)?

Note for crypto readers — “decentralized” as defined in this post is not blockchain-related. If you’re interested in healthcare blockchains, check out the Mt. Sinai’s Center for Biomedical Blockchain Research (CBBR) Op-Ed in STAT News and this crowdsourced biomedical blockchain project list.

Two components: “where” and “how” patient data are collected

We proposed that two features of data collection that determine how “decentralized” a clinical trial is:

Why are decentralized clinical trials attractive?

DCTs have a long list of benefits, many of which were published last week in STAT News First Opinion by Andreas Koester, M.D., the global head of Janssen Clinical Innovation. DCTs can recruit more people into trials, increase retention and engagement, collect more continuous data in natural settings, while shortening the study time (faster to market), and decreasing costs.

Should all studies be fully decentralized?

No — “fully decentralized” does not make sense for all types of research. Some studies may require an MRI or CT scan, and these technologies are expensive and are maintained at a clinical trial site. Also, the study protocol may require a blood draw, which is challenging to do at home with personalized tools (RIP Theranos).

Which organizations are supporting decentralized trials?

Pfizer’s 2011 REMOTE (Research On Electronic Monitoring of Overactive Bladder Treatment Experience) study is widely referenced as the first clinical trial of an FDA-approved pharmaceutical, which used digital technologies to recruit and manage participants entirely from their homes. This study also pioneered one of the first versions of electronic informed consent (eConsent).

Our landscape map updated September 2018. To see the most recent version, check out Elektra Labs.

Related Initiatives

Overtime, we hope to collaborate with other catalogs like eClinicalHealth’s EDCMarket to create a more holistic view of company offerings to support software-enabled clinical trials. EDC Market’s data is becoming out of date and the team is open to finding partners to revive and expand the database.

What’s next?

We believe that many clinically-validated endpoints used in research will eventually transition into clinical care. Historically, measures that supported research (“endpoints”) and care (“outcomes”) were siloed, but we are seeing examples of these measurements merging. Many companies are working towards a universal vision of human digital measurement across the continuum of research and clinical care.



HumanFirst (formerly Elektra Labs) enables better integration of digital health technologies (DHTs) in clinical trials for safer, more effective, and more equitable healthcare outcomes.

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Andy Coravos

CEO @ HumanFirst. Former US FDA. Decentralized clinical research. Curious about biotechs + psychedelic compounds. BoD @ VisionSpring. The party is now