VP Clinical Trials Global Sales, Loftware

Warren Stacey

As it stands, labeling is not a priority for most C-suite executives, indeed it's unlikely to even be on their radar, however, this is, in all probability, something of an oversight. Ultimately a label is a pharma company's primary communication mechanism, providing a channel for direct engagement with health care professionals and patients. It is a touch point that can be used to generate insight into customer behavior that is invaluable to top-level decision making.

We know that adherence is of critical importance to pharma at all stages of a drug lifecycle, but it is especially relevant during the clinical trial process. The primary cause of Phase III trial failure continues to be the inability of sponsors to demonstrate efficacy, often as a result of participants diverging from trial protocols, muddying the data. Research has even indicated that almost a third of Phase III participants are no longer adhering to their intended regimen by the 100th day of a trial.

A failed trial will slow a drug's path to market, while all the time the patent clock is ticking, shrinking the profit-making window. Plus, poor adherence can have economic repercussions even when trials are successful if it leads to a drug not living up to its full potential—underwhelming results make it considerably harder to demonstrate value to health systems, impacting the price that a drug can command. Therefore, it is easy to see the significant value associated with methods to encourage greater patient adherence during a trial.

Working in harmony with other smart packaging technologies, eLabels have the potential to provide an additional robust source of data, while also helping ensure the cleanliness and completeness of the overall dataset.

Given their ubiquity following the pandemic, it is easy to forget how QR codes had struggled for many years to gain a foothold in the minds of many consumers. Now, everyone knows how to scan a code for all manner of purposes, from ordering a round of drinks, to checking into a venue for contact tracing purposes.

These simple matrix barcodes, which can link to digital environments containing a veritable treasure trove of information, are being seized upon by many industries, from healthcare to hospitality, where companies are eager to experiment. However, in the clinical trials sector, QR codes and the resources they connect are still not commonplace, despite being relatively simple to implement. Why are we not seeing a surge in the adoption of eLabeling to complement some of the other smart packaging technologies that are now on offer?

Much of this hesitancy can be ascribed to the reluctance of regulators to allow information to be provided exclusively in digital form, coupled with the fact that they are unlikely to change their stance any time soon.

This position is understandable when you consider how difficult it is to wean people off physical forms of information. Decades after they were first mooted, the vaunted paperless office remains a chimera for most organizations, even with significant changes to working habits and digitally savvy generations making up an ever-greater proportion of the workforce. Organizations continue to shuffle around mounds of paper due to legacy systems or the preferences of various teams, and in many ways, a typical clinical trial is like most workplaces—good stratification means that you need to cater for everyone, not just those who are adept at using the latest technology. With that in mind, physical IFUs (Instructions For Use) are going to be a fixture of clinical trials for the foreseeable.

So, if there is a continued requirement for physical assets, where is the incentive for organizations to invest in new digital alternatives which would supplement rather than replace traditional labels? To understand, we first need to stop looking at labels as simply a compliance issue and consider their intrinsic value.

When you strip it back to its foundation, a label is a medium of communication between a manufacturer and the intended recipient of a product. In a clinical trial, the label on a device or IMP (Investigational Medicinal Products) is normally intended for two key audiences; the health care professionals overseeing the trial and the participants who are the end consumers. What is often seen as banal and simplistic is a valuable touchpoint that can be used to enhance the flow of information and deliver efficiencies and improved trial outcomes.

By untethering this information from a printed booklet in a trial pack, we can offer additional information in different formats and regularly update this in response to patient feedback. From interactive administration instructions to prompts for real-time feedback, a scan of a QR code linking to an eLabel can initiate a range of measures designed to improve the patient experience and improve adherence.

This is particularly valuable when you consider the growing popularity of decentralized trial models, especially those that involve direct to patient dispensing. Organizations delivering clinical trials need to adopt all of the tools at their disposal that allow for more effective communication at a distance.

Furthermore, given their essential nature, labels are also the ideal vehicle for integrating additional smart technology into packaging to improve adherence, something which clinical trial supply specialists RxSource is increasingly offering to customers. An array of sensors can be embedded into the label stock, from RFID tags for tracking purposes to temperature nodes that check drugs have remained at safe temperatures during transit. The packaging gurus at Essentra, have also been keen advocates of using RFID sensors to log data, enhancing tracking and traceability, and improving the security and robustness of the supply chain.

Working in partnership with regulators to drive innovation

While their focus is rightly on patient safety, regulators need to stay abreast of the potential opportunities afforded by bleeding-edge technology. Currently, sponsors bear the entire burden of demonstrating potential benefits to health outcomes, and this is achieved by running processes in parallel to generate supportive data for regulatory change.

However, only the biggest trial sponsors have the resources to justify the costs of a twin-track approach to trial management, allowing them to experiment with new ways of working. This means that it takes much longer to gather the data necessary to demonstrate the potential benefits of technology to patients. We need to take a risk-based approach to remove roadblocks, allowing more organizations to experiment so that we can rapidly gather more data on how the latest technology can work in practice.

For example, the growth of personalized medicine is creating a new set of challenges for the clinical trial supply chain with every label requiring patient data to ensure each tailored drug arrives in the hands of the person it has been designed to treat. Understandably this data requires careful handling to protect the privacy of patients, however, it would be beneficial if regulators could provide greater clarity on what is permissible and sensible when it comes to data handling processes, to avoid unintendedly stymying innovation.

Additionally, there would be a huge benefit from regulators working with labeling system providers to create a digital roadmap of upcoming regulatory changes. Labeling systems designed for a clinical setting will offer regulatory rule validation based on the latest regulatory intelligence, however, even the best systems take time for changes to trickle down. An automated syndicated feed of pending regulatory changes designed to be integrated into labeling systems would benefit all stakeholders, providing greater assurance that the latest rules are being followed.

Labeling is absolutely critical to pharma—an unlabeled or incorrectly labeled product is unsaleable and margins remain wholly theoretical, and as we’ve discussed, labeling is so much more than just a compliance issue. It is time for the c-suite to start paying greater attention to labeling, appreciating the value it offers to the business and applying pressure on regulators to create an environment where innovation is encouraged.

Regardless of whether you want to push boundaries or simply get the job done, your labeling system is a crucial cog, that needs to be kept well-oiled to ensure that it doesn’t become a hurdle to the realization of your organization’s vision.

, VP Clinical Trials Global Sales, Loftware

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