Blockchain x Clinical Trials

Don’t worry, the data is sound

How we applied blockchain technology to enhance data quality in clinical trials. Alongside a customized user experience, we developed ePID, an app that simplifies the recording of clinical trial data for the benefit of patients.

Clinical trials are a crucial step in medical progress, serving as a bridge between drug development theory and real-world application. Successful trials are essential for bringing new drugs to market and ultimately improving people's lives. 

Understandably, it’s vital to get it right.

Traditional methods of conducting trials often present challenges related to titration, which involves adjusting doses based on data received, and consequently, data collection. This can lead to issues with efficacy.

In short: bad or insufficient data can result in delays and other adverse effects.

At Novo Nordisk, we aimed to find an innovative digital solution for collecting daily data from patients at home, specifically in obesity and diabetes clinical trials. We brought together a team of software engineers, UX/UI designers, cyber risk managers, solution and domain experts and other tech specialists to try to come up with a solution.

ePID:

the Electronic Patient Interactive Device. Patients use a smartphone to automatically record data from blood pricks and send it directly to the researchers, bypassing the need for manual recording.

The problem and the birth of ePID

Clinical trials, by their nature, involve humans taking drugs and recording the effects. Typically, this means participants have to record their data at home and make frequent visits to clinical facilities. As you can imagine, there are often travel inconveniences, scheduling problems, and unexpected health conditions that add to delays in recordings, or simply inaccurate devices. Add COVID into the mix and all those problems were further exacerbated.  

Furthermore, the traditional method of data collection involves using pen and paper, which, once again, frequently results in inaccuracies and delays in data submission. Even something as basic as unclear handwriting can lead to problems.

“Collecting data electronically is a benefit for most involved parties in a clinical trial – health care professionals, patients, and Novo Nordisk. It makes it easier for both participants and health care professionals to do their tasks, which again ensures higher data quality, thereby improving the labelling of drugs and the speed of getting them to market.”
Martin Thuesen, Senior Director, Head of ePID at Novo Nordisk

The birth of ePID

When developing ePID, the goal was to facilitate real-time data collection directly from participants using connected devices. This approach aimed to reduce obstacles for participants when recording data, making it more timely and accurate.

Using Microsoft as their techstack, the digital team created an app that effectively tackled the issue and resolved the inefficiencies associated with the traditional pen-and-paper data collection approach. This not only improved data accuracy, but also encouraged more interaction between patients and healthcare professional (HCP). The new digital solution also enables something that no external provider could offer – a digital and traceable method for managing the titration algorithms developed by Novo Nordisk's medical experts.

Block-unchained

Understandably, medical regulators see potential conflicts of interest when a drug company collects data directly from clinical trial patients to draw their own conclusions – it’s in a company’s interest to see data that benefits them. To address this, the software engineers at Novo Nordisk applied existing blockchain technology to ensure that the data hadn’t been tampered with or altered in any way. This was pivotal, as it meant full traceability and proof that the collected data has not been changed in the clinical trial.

“The ledger technology brings us in a position where we can mathematically prove data integrity. This a huge step from previous opportunities”
Lars Hyltoft, Digital Quality Director at Novo Nordisk

Streamlined and ready to go

Since its inception in December 2020, the ePID platform has already made a significant impact. It's been deployed in 13 clinical trials, encompassing over 12,000 participants across 43 countries and has collected over 3.8 million verified data points.

The platform's potential is not confined to efficiency improvements. By enhancing data flow and trial participation, ePID can contribute in making the drug development process more efficient and effective. It also serves an example of how to apply digital innovation to a relatively restrictive clinical trial space. By leveraging cutting-edge technology and applying a user-friendly interface the path is being paved for improving the process of clinical trials, faster drug development and better patient experiences.

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