In such a connected world, why are clinical trials so disconnected?

Why is there such a disconnect between EHRs, DHTs, and EDCs? And what can we do about it?

Man concentrating at computer screen

I recently read a statement by SpencerDorn, Vice Chair and Professor of Medicine at UNC, that got me thinking…

“It's wild how healthcare can feel both extraordinarily futuristic and unbelievably archaic at the exact same time.”

As a clinical research professional with a decade of experience under my belt, this hit me HARD. We continuously see major innovations in research and in clinical practice – we can find cures for the incurable, we can create devices that let us check our glucose levels and emails at the same time, and we can develop life-saving vaccines at light speed (among other amazing advances).

And yet, we still find ourselves having to deal with disparate systems and manual approaches that add immense burden to the already heavy workload of our research teams.  We have or can generate millions of relevant data points, but we can’t seem to access them when we need to, which slows down our progress and increases trial costs.  

Why, in such a connected world, are clinical trials still so disconnected?  Why in a world with such technological advancements do study staff feel like they’re stuck in the stone ages?  And, most importantly, what can we do about it?  

A recent FDA guidance on Digital HealthTechnologies (DHTs) provided a few key insights that may help answer this burning question.  

"Advances in technology, including sensors, general-purpose computing platforms, and methods for data processing, transmission, and storage have transformed the ability to remotely obtain and analyze clinically relevant information from individuals. DHTs used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research.”  (FDA: DigitalHealth Technologies for Remote Data Acquisition in Clinical Investigations)

Today’s DHTs (devices like apps, wearables,software, and sensors that generate a significant amount of data) need to be well-suited for their intended use. In other words, the design of the DHT should begin with its intended purpose, just like a building's design should be based on its intended use.

But this alone is not enough; DHTs should also be designed for seamless integration with other general-purpose computing platforms, including EDCs, data repositories, communication networks, etc.  One way to achieve this is to ensure that our DHTs and our general-purpose computing platforms are all speaking the same language (like HL7® FHIR® – thank you, 21st Century Cures Act).  

Taking it one step further, our general-purpose computing platforms must be flexible, adaptable, and agile enough to connect to and communicate with many different DHTs as well as with other general-purpose computing platforms.  We need wearables and other data collection devices to connect to the EHR and to an EDC; and we need the EDC to connect to the EHR and to a public health registry, creating a closed circle of accessible, easy to acquire (and difficult to manipulate) data.  With this system of continuous communication, we can minimize the need for manual transcription and dramatically reduce data entry errors.  This is one way to make clinical research more efficient, to get and stay connected, and keep clinical data where it needs to be.

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