Keeping tabs on trials

Paul Peach, pharmaceutical sales consultant at label specialist Denny Bros, discusses the use of leaflet-labels in ensuring international clinical trials are completed successfully

Clinical trials are clearly a crucial element within drug development. The trials process, however, has a number of complex issues to deal with; not least those concerned with international clinical trials – the logistics and costs, in terms of both time and money. One solution that has helped reduce this complexity is the development of the leaflet-label, and suppliers around the world report growing interest from contract research organisations (CROs) in their products, in particular where global trials are required.

In a clinical trial the transfer and testing of vital product information is a key element. The information must be accurate and deliver the correct instructions in order for the drug to be effective. Equally, the labelling must not identify any difference between the active drug and the placebo – otherwise it would unblind the clinical trial and render it ineffective as a reliable test.

Carried out on a global scale, the logistical problems can be, at best, time consuming and add extra cost. Taken to its extreme, the concern must be that vital drugs are withheld or, at worst, never become licensed due to the impact of these added complexities.

The clinical testing of new drugs is carried out in three phases:

Phase I starts with testing a small group of patients. The number increases as initial findings are fed back to the investigators. Larger groups of patients are recruited for the next two phases in which the trial may spread over several years and across many countries.

Traditionally the labelling and packaging has been done on a 'by country' basis, including distribution. However, predicting the patient enrolment for the trial over long periods of time in different countries is no exact science. Sufficient materials in each language need to be produced to allow for the most 'likely' outcome – which inevitably means higher material usage and, therefore, more waste. It also entails higher labour costs throughout the process.

The impact may be the same as far as other consumable products are concerned: stocks of plain labels, thermal printing ribbons, printing heads and label printing software will all add to the costs – something that could be avoided, if only a suitable system could be found to rationalise the labelling.

positive impact on distribution

Many of these unwelcome elements associated with clinical trials can be solved by a leaflet-label system. A leaflet-label (traditionally, a combination of a printed folded leaflet with a self-adhesive label) is applied directly to the container. It occupies the same space as a standard label but its many pages multiply the available space.

This means that many languages can be included in the same leaflet for the same product – one 'label', one printing and application process and one stock level to manage – greatly reducing the level of complexity and cost.

The positive impact on distribution is clear and waste levels are reduced since the CRO does not have to overstock in the various languages. Small excess stock levels can still be used, redistributed to anywhere where further trials require. With one leaflet-label and one packaging solution, the trial can easily be extended at any time to new countries not on the original list. Most leaflet-label suppliers claim to be able to produce formats in up to 36 pages, and it is unlikely that the multi-lingual requirement would exceed this.

There is also a knock-on security benefit. With one leaflet-label type, already scanned to verify correct leaflet-to-label match, only one variant needs to be checked – inventory time is drastically reduced, as are any risks of mislabelling. Time is such an important factor and leaflet-labels reduce handling times and improve delivery times thereby reducing yet another complexity.

A key element in the relationship between CRO and label supplier is flexibility. On the face of it, the leaflet-label appears to be a standard product – and so it is, in the sense that it improves the efficiency of the information transmission part of the clinical trial and at the same time creates the other benefits discussed above. Solutions, however, are constantly being developed to fit the precise nature of the clinical trial and the requirements of the particular applications.

For example, leaflet-labels can be designed to apply to virtually any type of container, regardless of shape, size and container material. As far as application goes, leaflet-labels can be applied using standard label applicators but equally applied by hand where this is a more practicable solution.

The leaflet-label is best known as an 'on-pack' solution – it is applied to the container directly. This removes the need for and associated costs of cartons, where their principal purpose is to house the leaflet. However, there are also 'in-pack' solutions where the leaflet element resides within the packaging. Denny Bros has developed PackXtra, which combines the benefits of a leaflet-label with those of a carton. Applied automatically to the inside of the carton, a simple opening device reveals the leaflet-label to the patient.

Matching GMP standards

Security features, common to any pharmaceutical labelling, can be included in the leaflet-label. They might include any type of pharma code, security printing techniques and holographic devices. Overprinting (and backprinting) of batch codes, unique and randomised numbering are all standard features. Each of these elements can be added to the trial product so that the total testing is complete.

There is another important reason why CROs have turned to the leaflet-label supplier so readily: it is because the leading label suppliers can match GMP standards within their own production environments. It is only reasonable that if clinical trials are carried out under strict standards of quality and security, the leaflet-label suppliers must themselves set similarly appropriate standards.

Companies such as Denny Bros have invested in dedicated manufacturing facilities for clinical trials and many of its processes are tailored to satisfy the rigours of pharmaceutical audits.

The role of the clinical trial is essential to 'prove' the drug. This process need not be comprised by the challenge of communicating the vital information that must now form part of that testing process. Leaflet-labels create the solution to reduce the complexity of clinical trials.