Survey finds quality control is a major challenge in clinical labeling

Clinical Trials: When the Label became more Significant than the Drug Itself…

The importance of labeling in clinical trials gets very little exposure. However, as the global war for patients intensifies in an increasingly competitive trial 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.

The revelation stimulates an interesting question: when did the packaging of a clinical trial product become more significant than the actual drug? The answer? When the patient couldn’t understand it, and subsequently gave up. And, whilst it might sound far-fetched, the reality is that it’s happening every day, on a global scale.

Think global, speak local

So how did we get here, and how do we solve the problem? As we know, the clinical trial market is not only global, today it touches more markets than ever before.

The US National Institute of Health’s clinical studies registry,, currently lists registrations for over 225,000 trials covering more than 160 countries, all of which are enrolling patients today. The globalization of clinical trials has naturally 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 labeling 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. It needs to speak their language.

That information is typically delivered through multipage booklets or IFUs (Information for Use), which have become key constituents in a burgeoning portfolio of packaging and labeling 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 labeling process a complex one, fraught with inherent risks. A labeling error can have substantial financial, reputational and, sometimes, human costs.

Patient disengagement

In the case of clinical trials, sub-optimal labeling has ramifications that go beyond financial and regulatory risks. It’s a common, though unheralded, catalyst for subject attrition. Typically, patients can find the trial process complex and distressing. Their 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. Often, if patients are unsure or realize they have made a mistake, it’s easy for them to exclude themselves from the trial.

For the pharmaceutical company, the implications are severe. Enrolling target patients is difficult enough, so to allow them to slip through your fingers because of poor labeling is both careless and costly. Patient retention is a major cause of trial delays, with associated financial and operational costs. But ineffective labeling is also a missed opportunity. For study sponsors, contact with patients on global trials can be very limited. The only interaction a company has with a subject is often through the product packaging itself.

In a pharma environment dominated by aspirations of patient-centricity, it’s easy to underestimate the important role packaging can play in patient engagement during clinical studies. In many cases, the label is not just the primary touch point, it’s the only touch point – 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.

It’s an opportunity that’s often squandered. In the worst examples, the information provided via multi-language booklets may do enough to satisfy regulatory requirements, but it relies on translations that fail to appreciate local, cultural and clinical nuances. In the process, patients become confused, disengaged and, ultimately, decide to quit their trial.

Local language challenges
There are many reasons why local language labeling has always been difficult; outsourced translation services may not understand the context of clinical trial text, while dosage quantities and instructions typically rely on complicated phrases. Similarly, where companies rely on native language specialists as part of label design and approval, processes can be slow, leading to increased costs and delays. Moreover, visual inspection of Asian and Arabic languages, which use unfamiliar symbols and fonts, can be difficult and labour-intensive.

The challenge of local language labeling, and of maximizing the real estate of complex label designs, once again shines a light on the strategic importance of an effective labeling infrastructure. In an increasingly competitive global marketplace where drug development costs continue to rise, smart investment in innovative labeling technologies can lead to a significant reduction in the cost and operational impact of subject attrition.

The most effective systems will sit at the center of an enterprise and take an integrated, data-driven approach to label life-cycle management. By focusing on the data, rather than simply the label, organizations 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.

There are many reasons why a patient may abandon a clinical trial – but the label doesn’t need to be one of them.

Mind Your Language! Requirements for Local Language Labeling in Clinical Trials


mark cusworth - Clinical Trials: When the Label became more Significant than the Drug Itself…

About the author:

Mark Cusworth is the VP Research and Development at PRISYM ID. He has over 15 years of experience heading up a team providing off the shelf and tailored solutions to Clinical Trial companies. During this time, he has seen many changes to the industry including significant tightening of regulations, challenges of globalisation as well as the shift from Subject based to Interactive Response Technology (IRT) trials.