The importance of labelling in clinical trials gets very little exposure. However, as the global war for patients intensifies in an increasingly competitive market, and with subject attrition rates commonly shown to be between 15–20%, pharmaceutical companies are slowly discovering that the packaging of their products can be a key determinant of patient retention.
Although it might sound far-fetched, the reality is that if patients are unable to understand the instructions within the IFU (Information for Use), they are increasingly likely to give up. Moreover, it’s happening every day, on a global scale.
Think global, speak local
The globalisation of clinical trials has brought with it a convergence of logistical, operational and cultural challenges.
Moreover, it’s forced the pharmaceutical industry to adapt 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.
That information is typically delivered through multipage booklets or IFUs, which have become key constituents in a burgeoning portfolio of packaging and labelling materials. In a global marketplace, these materials typically include information in multiple languages, 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.
In the case of clinical trials, suboptimal labelling is a common, though unheralded, catalyst for subject attrition. A patient’s ability to follow the right regimen and maintain the required frequency and dosage depends on a variety of factors, not least understanding how the product should be administered. For study sponsors, contact with patients on global trials can be very limited. Indeed, 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.
Local language challenges
There are many reasons why local language labelling has always been difficult; outsourced translation services may not understand the context of clinical trial text, whereas dosage quantities and instructions typically rely on complicated phrases. Similarly, when companies rely on native language specialists as part of label design and approval, processes can be slow, leading to increased costs and delays. Moreover, the visual inspection of Asian and Arabic languages, which use unfamiliar symbols and fonts, can be labour intensive.
The challenge of local language labelling, and of maximising the real estate of complex label designs, shines a light on the strategic importance of an effective labelling infrastructure. In an increasingly competitive global marketplace wherein drug development costs continue to rise, smart investment in innovative labelling technologies can lead to significant reductions 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. There are many reasons why a patient may abandon a clinical trial — but the label doesn’t need to be one of them.
