For too long, poor medication adherence has been the elephant in the consulting room. The common, age-old problem has the potential to bring a clinical trial to its knees, and yet, with no viable solution on the table, sponsors and CROs have been forced to ignore it.
But that is changing.
The integration of advanced technologies, including smart packaging and powerful data analytics, is driving a revolution in adherence monitoring that is accelerating drug development times, reducing clinical research costs, and making safer trials for participants.
The story so far
Poor adherence to investigational products during clinical trials is a costly problem.
The statistics are staggering: each participant in a phase III clinical trial is responsible for an average of $42,000 in fees again a third are non-members at day 100. In all phases, 50% of patients admit to not following the dosing protocol.
This is an issue that negatively impacts patient outcomes, leads to an underestimation of product efficacy, and may threaten study success.
The power of the study is essential in the design of clinical trials. The higher the power of the study, the higher the likelihood of detecting a drug’s true effect. However, when subjects do not take their medications as directed, this decreases the size of the effect and increases the variability.
As study planners know, any decrease in adherence must be accompanied by a costly and labor-intensive increase in the number of study participants if power is to be maintained. . Non-adherence therefore has a direct effect on the cost and duration of clinical trials.
Yet traditional methods of adherence monitoring, such as pill counting, self-reporting, or biomarker measurements, are simply not sensitive enough to provide actionable holistic information. They are open to bias, offer only a snapshot of medication-taking behavior, and impose additional burden on sites and patients.
None of this is new – sponsors and CROs have faced the same problem for decades – but in the absence of a workable solution, it has been swept under the rug.
Digital adherence monitoring, which combines the power of connected packaging and powerful data analytics, is changing the conversation.
Smart packaging, such as connected pre-filled syringes, for example, can collect essential information, such as the end of the injection, the time and date of the dose, the type of drug, the batch number and the date of expiration.
This data is then fed to a cloud-based platform for sophisticated analysis of medication-taking behaviors. The result is visualizations that allow study teams to spot erratic dosing patterns, enabling risk stratification and guiding individualized interventions that account for the complexity of poor medication adherence.
The approach can even be integrated with third-party apps, such as patient-facing apps designed to continuously encourage adherence and engagement with the protocol.
Basically, it provides a complete and accurate understanding of the patient adherence behaviors and risk indicators that matter most to student success.
Clinical trials are experiencing two separate but interconnected revolutions – and digital adherence monitoring is playing a central role in both.
In recent years, there has been a large-scale shift towards more patient-centered studies, at least in part, with the goal of improving retention.
For decades, sponsors and CROs have tried to fill this gap by recruiting replacement participants. However, this strategy is extremely costly and the era of personalized medicine, which restricts the pool of eligible patients, quickly makes it unfeasible.
Non-adherence can be a warning sign of discontinuation, and it offers clues to poor product efficacy, intolerable side effects, or administration problems, all of which can lead to poor retention.
At the same time, we are also witnessing the digital transformation of the sector. In recent years, a wide variety of digital health services and applications have been designed to shorten, speed up and make more efficient the long and winding road to market access.
From electronic data capture to wearable sensors, each has the potential to streamline or optimize an element of a clinical trial. But no element has a greater impact on the chances of success of the study than treatment compliance.
The literature shows that the main source of clinical trial failure over the past 30 years has been an inability to demonstrate its effectiveness.
Security is another major cause of failure, but this result does not necessarily mean that the drug is dangerous. Incorrect dosing due to poor compliance, for example, can lead to adverse events which do not accurately reflect the effect of the product.
Ultimately, the reasons for study failure are as varied and complex as the trials themselves. Yet there is a common thread that runs through the most common factors of efficacy, safety and dose selection – and that is poor medication adherence.
turn the tide
Technological innovation is the key to disrupting the status quo, optimizing clinical trials, and finally solving the decades-old problem of poor compliance.
To harness this potential, integrated, practice-changing tools, such as digital membership monitoring ecosystems, are rapidly integrating into routine workflows and helping to reshape the landscape to ensure efficient and robust research of the 21st century.
Photo: Warchi, Getty Images