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International Clinical Trials

A Surprise Package

As global healthcare grapples with the problem of medication 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 trials; they are often unsuccessful when patients do not comply with their medication regimes. Furthermore, if the cost of recruiting patients to studies is high, the price of failing to keep them there is even higher.

Yet, despite long-standing efforts to ensure that patients remain engaged and motivated through the duration of studies, subject attrition is the norm as opposed to the exception. Research shows that these rates are commonly between 15-20% and can sometimes even exceed 30%. The factors that influence study dropouts are varied, but largely predictable. Despite this, one significant barrier to recruiting patients is often overlooked: the label.

The importance of labelling in clinical trials gets very little exposure. However, as the war for patients intensifies in an increasingly competitive trial market, pharmaceutical companies are slowly discovering that the packaging of their products can be a key determinant of keeping patients. The revelation stimulates an interesting question: when did the packaging become more significant than the actual drug? The answer: when the patient could not understand it and subsequently gave up. It sounds far-fetched, but it is happening every day on a global scale. As the cost of drug development escalates, perhaps it is time for the industry to review its labelling infrastructure to alleviate the expense and implications of subject attrition.

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Mark Cusworth is the Vice President of R&D 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, Mark 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 trials.
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