Labelling expert Faubel on how individual solutions for blinding clinical trials are now gaining momentum
Faubel
About 5,000 clinical studies are initiated every year. Drug candidates are tested in the form of capsules, tablets, drinking solutions, salves, injections, sprays and even plasters depending on the area of application. In addition to the product under study, participants may receive a placebo, a comparator as well as an additional or substitute drug.
Complex situation
Research companies in the pharmaceutical industry are often faced with the challenge of appropriately blinding the study medication. The varied assessment of treatment results - often labelled as informational, judgment or ascertainment bias - is thus restricted. Furthermore, blinding can improve compliance in study participants and the willingness to remain in the trial, while reducing the use of additional care or treatment measures.
Either the primary packaging masks the shape, size, colour, texture, weight, smell and/or the taste of the drugs, or the secondary packaging takes on this task. Blinding is a substitute for repackaging, which is often not possible. Blinding can take place on a single- or double-blind basis; the term triple-blind is also used occasionally. The degree of blinding is determined by whether individual or multiple participants in the trial are unaware of the allocation of test subjects to treatment or control groups.
“Given this complex initial situation, the requirements for the packaging and labelling of study medications are extremely high”, said Anthony Morrow, business development manager at Faubel, serving customers in Northern Europe. Drinking solutions are often packaged in bottles or cans, capsules and tablets in blisters, wallets or tins, salves in tubes, jars or sachets, injections in vials, syringes, ampoules or bags, sprays in aerosol cans or inhalers, and plasters in boxes.
Labels for flexible use
Many primary packaging methods, e.g. syringes or tubes, can be simultaneously blinded and marked using labels. Not only are labels incredibly flexible in their design, format and scale, their material and adhesive properties can be adapted to filling, storage and transport conditions. Film, paper and ink give the package an opaque and lightproof cover. When it comes to multinational clinical studies, different country languages usually need to be factored in. In this case, the use of a booklet label is ideal, one that can hold up to 113 pages. Unusual container shapes require considerable effort in project-related development from packaging suppliers. Overall concepts integrating various secondary packaging materials are often used like for blinding syringes, for example.
Boxes – overall concepts
Complete masking of shape, size and weight of the primary packaging and the colour of the trial products can be achieved by using tailor-made boxes. These can be used in single- and double-blind studies primarily for cans, vials, bottles and bags. Boxes can be produced from rigid cardboard. Recently it has even become possible to make boxes from plastic using 3D printing. This way, a vast array of different shapes can be produced in extremely limited series. A built-in control window enables drug identification in case of emergency, meaning on first opening it becomes clearly visible.
As with labels, boxes can be complemented by optional properties such as tamper-evident elements using seal labels or attachment bands. One advantage of using boxes is that they can be further processed without using tools or even configuring the packaging line.
Efficiency in blinding
The requirements on blinding solutions for clinical studies will continue to grow. The possibilities described cover only a fraction of the day-to-day requirements with which packaging manufacturers are confronted. It is generally recognised that this constant confrontation with legally-mandated requirements, individual customer demands, new materials and innovative technologies is driving the capacity to develop. “After all, only those who can offer their customers sophisticated concepts can guarantee efficiency in blinding and the usability of treatment results, thus saving contract-research institutes and research-based pharmaceutical companies effort, time and money on a sustainable basis”, Morrow said.