If you see it in a dashboard, its too late.

Courtesy of Yaron Koler — friend, professional software engineer and liver cancer survivor

The future: tech-driven data and safety monitoring

Running clinical trials with the help of tech is becoming much more prevalent, but it’s unclear if data and safety monitoring has kept up.

COVID-19 accelerated use of digital tech in clinical trials

During COVID-19 (which now seems to be the new normal), drug companies started running so-called decentralized clinical trials (DCT) with the help of digital technologies like Zoom and mobile apps. Until now, pharma went to hospital systems and specialty research sites to recruit patients. With COVID-19 — that option became almost impossible.

The basics of technology risk

  1. Risk does not come out of thin air. You need to monitor and analyze risk.
    Suppose you’re the VP Sales of a chain of pharmacies. You might guess that you’re losing customers because of parking and public transportation. By analyzing parking capacity and bus stop locations, you can create an accessibility metric and measure the risk to losing business because the pharmacy locations are not accessible to people.
  2. Software products often promote new features (like being faster) without considering security.
  3. The world of tech is divided into camps. Application camps, database camps, cloud camps, AI camps and many more.
  4. People in the application software camp, almost never talk about the role of their software in data and safety monitoring. It’s almost always someone else’s problem.
  5. Application software is notoriously vulnerable. Buggy software is vulnerable software.
  6. The world is complex. Clinical trials have software running on patient phones, site coordinator tablets, on hospital systems and FedEx APIs. More complex means more things will go wrong.
  7. The world is is moving faster than the government. The latest FDA guidance for monitoring clinical trials was released in 2013. In other words, don’t expect regulation to effectively mitigate tech risk.

How patient data and safety monitoring fell behind

Clinical trial software companies typically tout the advantages of DCT for faster recruitment and availability to more diverse patient populations.

The challenges of data and safety monitoring in DCT

The risk-management loop — a tech-driven approach to patient data and safety monitoring

We now describe a tech-driven approach for monitoring data and safety in tech-driven clinical trials. We call this the risk-management loop.

A risk management loop — faster and more agile

A risk management loop provides a systematic and tech-driven way to think about decentralized clinical trial risk. The tech-driven approach is agile, and acknowledges the fact that decentralized clinical trials are technology-intensive and dependent upon reliability of complex software systems which are vulnerable in many different ways.

The clinical trial risk management loop

Creative Commons Attribution — Danny Lieberman — if you like it, use it and mention me.

Summary

Outdated data and safety monitoring processes have fallen behind the volume, velocity and variety of data in DCT.

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Danny Lieberman

Danny Lieberman

I am a physicist by training, serious amateur musician and everyday biker. Working in cybersecurity and AI-driven monitoring of clinical trials.