So strong is the human allegiance to the status quo that it is rare for the momentum of change not to be accompanied by frictional forces of resistance.
Rather than running towards new ways of working, our natural instinct typically tends towards hesitancy and caution. We are predisposed to question the underlying rationale – to understand the what, the how and, crucially, the why. But it is only through an acceptance of change that we can explore new thinking and uncover the hidden pathways that lead to progress. In clinical trials, this can be seen in the transition towards today’s data-driven frameworks, which represent a clear departure from previously accepted models.
Indeed, for decades, clinical trials were centred more around the logistics of capturing participant data rather than the integrity of the data itself. Statisticians were effectively locked into a visit-based mindset, with data collection restricted to these scheduled moments in time. Visits also shaped the data recorded by Electronic Data Capture (EDC) systems, and the last visit of the follow-up period would typically provide the basis for assessment of the primary endpoint.
Over time, however, the flaws of this over-dependence on visits became evident. The resulting gaps in adherence data highlighted glaring weaknesses in the analysis of drug exposure and its relationship to efficacy and safety. Change was required to deliver better data, better analysis, and more efficient, effective studies.
That change arrived in the form of electronic monitoring. By facilitating a far more robust measure of adherence, this technology changed everything. Suddenly, trial co-ordinators had access to a continuous stream of highly granular, longitudinal data on exposure that was not defined by, or limited to, visits.
But the emergence of this rich stream of data also served to highlight a striking imbalance when contrasted with the comparatively sparse data on participant outcomes. And there was no simple way to integrate the continuous exposure data into the traditional visit-based trial frameworks, with the co-existence of the two approaches creating several areas of disharmony:
- Data overload
Huge volumes of time-stamped adherence events required new analytical approaches. - Misalignment of scales
Clinical outcomes are still often summarised in snapshots, while exposure is tracked daily or even hourly. - Operational barriers
Sites and sponsors must adapt systems, workflows, and oversight to handle longitudinal data streams.
Today, such difficulties are being overcome, and the underlying imbalance is being addressed, through a collective convergence on continuous methods of data measurement. The rapid uptake of patient-reported outcomes (PROs), wearable sensors and connected devices, for example, enables trial co-ordinators to gather richer outcome data, including the measurement of biomarkers, between visits.
Correspondingly, there is a reversal in the dynamic where detailed exposure data is considered the outlier; rather, it becomes a central parameter within a trial framework driven by continuous data, which delivers deeper insights, reduces risk and increases efficiency.
- Stronger causal insights
Aligning continuous exposure with continuous outcomes reveals patterns invisible in visit-based data. - Smarter risk management
Detailed adherence data supports Risk-Based Quality Management (RBQM), identifying sites, patients, or protocols at risk earlier. - More efficient trials
Understanding the true link between exposure and outcomes enables for the design of better protocols, reducing trial failure and accelerating drug development.
Such benefits underline the importance of moving away from legacy trial approaches characterised by visit-based snapshots and shifting towards continuous data streams that paint a far more vivid picture of the efficacy and safety of a given drug.
As with any change, it is inevitable that there will be points of friction on this journey. Even if there is understanding of ‘the what’, ‘the how’ and ‘the why’, there will still be a need to overcome inertia and encourage departure from existing norms. But with the potential to uncover life-enhancing, life-extending or life-saving treatments at stake, the price of progress far outweighs the cost of sticking with the status quo.
Establishing hard evidence for your trial…    
AARDEX has a best practice methodology, independent of any device package or software platform. Utilising our expertise and experience in medication adherence and patient compliance we acquire, monitor, analyse, guide and interpret data to deliver absolute clarity and bring confidence to sponsors, trialists, and ultimately, patients​.     
AARDEX is the only mature, robust and proven adherence solution on the market today, one that maximises the reward, mitigates the risk and delivers resolution for your clinical trial. All delivered with the clarity, integrity and certainty you need to proceed with complete confidence in the exposure-response.     quired to close this gap — ensuring that every dose, every patient, and every data point counts.
