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4G Clinical


This is the first in a series of posts covering our expert predictions for the clinical trial industry in 2022. Additionally, be sure to listen to the January 2022 episode of the Trial Trends podcast, "3 Trends That Will Shape 2022" for more insights for the coming year.


Real-time drug tracking will become a viable option for clinical trials by the close of 2022. Not just tracking a drug from the manufacturer to the clinical site, but true end-to-end tracking of every step of the drug’s journey.

This might be a difficult concept to grasp given that as recently as 2016, the idea of real-time drug tracking had just emerged as a "future innovation." So why now? We live in a world with a seemingly endless amount of smart devices.

According to the International Data Corporation (IDC), the Internet of Things (IoT)-connected machines and sensors over the next few years is forecasted to generate 79.4 zettabytes of data by 2025. For those less familiar, one zettabyte is equal to one trillion gigabytes, and IoT device usage is growing year over year, and the pharmaceutical industry is no exception.

Let’s also consider the evolving landscape of healthcare and clinical trials over the last two years during the pandemic. Telehealth became more accepted by stakeholders so patients did not have to go into the clinic. Clinical trial models shifted to allow patients to receive medications at home. And with that came a whole host of new technological innovations to move portions of the trial setting to a person’s home, safely, in a highly regulated environment.

As more decentralized trial models are explored, and more technologies become available to track portions of the drug’s journey in a clinical trial, all eyes turn to interoperability and audit trail. How can one utilize existing technologies and maintain true visibility into all touchpoints throughout a drug’s lifecycle? That’s where the concept of real-time tracking comes in.

In order for this to happen aligned with our prediction, there are several things to watch for over the coming year.

1) Technology continues to evolve. When you consider drug shipments, tracking, and storage, technology must provide more oversight, reporting, and supply solutions. As an example, shipments can include multiple sensors to monitor environmental indicators such as temperature, humidity, vibration, and light in real-time.

Connected technology has improved to a point where real-time tracking does not have to be a nebulous concept, but instead a potential foundation for monitoring drug delivery and communicating vital events, as the product travels through the supply chain from manufacturer to patient.

2) Transition is not immediate, but rather a process of improving aspects throughout the year. Building toward end-to-end tracking from current supply models can be overwhelming. But this doesn’t mean individual processes can’t be improved and updated.

For example, temperature data can be sent more frequently, to better illustrate environmental factors, such as humidity changes, air pressure variances, and even unexpected light exposure (such as when a box is opened, accidentally or intentionally). If delivery is negatively impacted due to changes that exceed established parameters, arrangements can be made to replace the shipment before the damaged product even arrives at a depot or site. This minimizes any delays in getting needed products to patients, ensuring correct dosing by a considerable margin.

3) Direct-to-Patient (DtP) trials are made safer with real-time data. Real-time tracking can regularly report conditions and potential excursions up until the moment the product is delivered. In turn, because direct-to-patient trials involve more oversight opportunities created by technology and information, it’s likely updated requirements will be established for those responsible for handling products.

New technologies can help ensure these requirements are met by each person involved, while also facilitating extra levels of caution and preparedness for maintaining proper temperature after the drug reaches the patient.

4) New regulations are likely to emerge. DtP trials bring drug delivery directly to patient homes, but new regulatory concerns come with them. Currently, there are some basic regulations centering on overseeing proper drug delivery and receipt. But, as real-time, end-to-end drug tracking comes closer to becoming a standard, new regulations will be necessary especially as it relates to patient privacy and safety.

For example, delivery process and blinding considerations need to extend to support practical at-home scenarios. If sensitive or unblinding information is not protected, the further participation of the patient and end-user can be compromised, risking trial success. The wider adoption of DtP in some countries depends on these processes, and expectations to more closely resemble those at-site.

5) 2022 will bring more questions and more possibilities. Of course, any prediction about pharma supply comes with a fair share of questions. How will increased tracking visibility affect pharma companies and clinical trials? How long will it take for updated delivery requirements to be standardized and enforced? Will there be any change management concerns for companies resistant to shifting approaches? Despite these questions, we remain confident in our prediction. While the global adoption of real-time drug tracking will extend well beyond this calendar year, 2022 will likely see a rise in real-time tracking as a viable option for trials.

The rate of adoption may vary, however, we believe increased use of connected technology will result in real-time tracking and reporting solutions becoming more commonplace. As a result, the influx of new data is likely to spur significant improvements for monitoring shipments and site storage, naturally leading to improved patient safety.