Mark Cusworth, vice president of R&D at PRISYM ID, explains how labelling can improve patient retention rates in clinical trials
AS global healthcare grapples the problem of medicines adherence, C. Everett Koop’s famous observation has become a familiar retort: “drugs don’t work in patients who don’t take them.” The same concept applies in clinical studies.
The importance of labelling in clinical trials gets very little exposure. But with the packaging of products increasingly a key determinant of patient retention, combined with the escalating cost of drug development, perhaps it’s time for industry to review its labelling infrastructure to alleviate the expense and implications of subject attrition.
THINK GLOBAL, SPEAK LOCAL
The globalisation of clinical trials today touches more markets than ever before, and has brought with it a convergence of logistical, operational and cultural challenges. Moreover, it’s lead to an increasingly complex and evolving regulatory environment. A key component of this is the need to comply with variable local language labelling requirements, not least in the safe distribution of medicines for clinical trials. With the global map for clinical studies now extensive, information to support the safe and effectual use of trial medicines must be coherent and understandable to the patients receiving them.
That information is typically delivered through multipage booklets or IFUs (Information for Use), typically including information in multiple languages, and combining patient-specific, product-specific and country-specific content. Much of this data is often stored in disparate local systems, spread across a global organisation – making the labelling process a complex one, fraught with inherent risks. A labelling error can have substantial financial, reputational and, sometimes, human costs.
For the pharmaceutical company, the implications can be severe. Enrolling target patients is difficult enough, so to allow them to slip through your fingers because of poor labelling is both careless and costly. Patient retention is a major cause of trial delays, with associated financial and operational costs. But ineffective labelling is also a missed opportunity. In many cases, the label is not just the primary touchpoint, it’s the only touchpoint – the sole means of influencing the patient or helping to make things easier for them.
What’s more, in many therapeutic areas, particularly with treatments for chronic disease, the packaging presents an early opportunity to drive long-term brand loyalty. Getting the local, cultural and clinical nuances of the language right is therefore paramount.
LANGUAGE CHALLENGES
The challenge and complexity of local language labelling – including the visual inspection of Asian and Arabic languages with unfamiliar symbols and fonts – and of maximising the real estate of complex label designs shines a light on the strategic importance of an effective labelling infrastructure. Smart investment in innovative labelling technologies can lead to a significant reduction in the cost and operational impact of subject attrition.
The most effective systems will sit at the centre of an enterprise and take an integrated, data-driven approach to label lifecycle management. By focusing on the data, rather than simply the label, organisations can develop a 360° view of their master data assets, and enjoy the flexibility to adapt and tailor content to meet country-specific requirements, also ensuring local regulatory compliance. The smartest technologies will include language and phrase management tools that allow translations to be pre-agreed and pre-approved, and clinical trial-specific terminology to be specified and validated.
In the same way that drugs don’t work in patients who don’t take them, clinical trials don’t work when patients drop out because they don’t understand how to comply. It’s a contentious suggestion that the packaging of a clinical trial product may be more significant than the drug itself – but if patients can’t confidently get beyond the packaging, the true benefits of high-value medicines will never be proven.
