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The use of digital technologies to establish and measure endpoints in clinical trials offers enormous potential to bring life-changing treatments to patients faster and more efficiently. However, as with any still-nascent field, pitfalls abound, even perhaps especially when everyone thinks they’ve covered all the basic considerations. As the phrase goes, all too often, people don’t know what they don’t know.

First, a moment of background. When a medical device receives 510(k) clearance, it is intended for clinical practice and doesn’t qualify a device to be used in clinical trials.The clearance process is very different from the FDA’s drug approval process. The main requirement for clearance is non-inferiority to an already cleared product. To show non-inferiority, or substantial equivalence, a new device may be tested side by side with an old device, possibly in entirely artificial conditions (for instance, rather than a human testing a spirometer to measure airflow or an accelerometer to measure motion, calibrated machines may stand in).

This is sufficient for care management, in which limits or inaccuracies in the data are largely tempered by the clinical judgment of healthcare professionals who review the data of individual patients and make a judgment call on how to interpret the results. But clinical research requires different standards, such as analytical validity a comparison to a gold standard, which requires a human subject study and often access to the raw data to make this inference.

A Pharma Fairy Tale

A story may illustrate how this pitfall can appear. Once upon a time, a pharma company hoped to add a digital endpoint to their trial, but most of the devices available were old, clunky, and disliked by patients. A new company gained 510(k) clearance for a device that seemed to be an improvement in every way. After careful consideration, it was agreed that the new device would be used in the trial, and the work began.

But the board of the new device manufacturer decreed otherwise. They required their company stay focused on care management, due to its larger market potential and smaller investment of resources. (From a one-company business perspective of course, they were perfectly right.)

The clinical trial team at the pharma company kept their research alive with the new device but without support from the device manufacturer. And so, a great deal of unplanned work was needed to do what the manufacturer could not. The trial was completed, but at the end of the day, the results demonstrated the device’s suboptimal performance which deemed it unsuitable for use in clinical research.

Good Intentions Gone Awry

Digital clinical trials are a difficult, competitive business. Eager new manufacturers without experience in clinical research may not fully grasp what they’re up against. Pharmaceutical organizations may be accustomed to collaborating with the best experts and may be unused to digital biomarkers and so they may misunderstand both the capabilities of the vendors they select and what they will need from those vendors. No deliberate misrepresentation is needed to create confusion. The best of intentions can go awry, and people can talk past each other without realizing it.

How is this to be avoided? There are two answers.

1. It may indeed make sense to use an older, tried-and-true device, even when its form factor looks outdated compared to a newer technology. This may be the case when both the equipment and its device manufacturer have successfully demonstrated the capability to support clinical trials.
2. It may make sense to use a newer device, particularly if it offers benefits or features that older tools don’t. But it may be necessary to test it in a dedicated study and even develop purpose-build software tools and integrations that work with the device’s raw data, rather than relying on the off-the-shelf software tools provided by the manufacturer.

Either approach can be successful when chosen with intention and deep understanding around the intricacies involved in including digital endpoints in clinical trials. It may seem like the big hurdles are at the beginning of the process in creating a digital endpoint for a trial, but it’s vital to have experience on your side to see and avoid less obvious hurdles that can be just as difficult.

Learn more about using digital endpoints in clinical trials from leading digital biomarker company Koneksa at