How to ensure quality and consistency in clinical trial labelling

Specifying clinical trial labels

Clinical trials on human volunteers are a vital step to bring new and improved drugs to market and for the advancement of treatment options. Trials have to be rigorously conducted meaning that every element, even a humble pharmaceutical label, must reach a high standard of quality and performance. The stakes are high and, even small variations in label size, design or print can potentially jeopardise months or even years of work for those involved in the trial.

There are two key elements to consider when specifying clinical trial labels:

Label performance

It’s essential that any drug labelling does not let down the trial due to non-performance. Here are some of the elements we consider when developing clinical trial labels:

  • Customised label shapes and styles –the type of clinical trial label needed will depend on the primary packaging of the drug to be tested. Cylindrical containers may benefit from a wraparound label, whereas a peel and reveal or blackout label would be more suitable for blister packs
  • Information to be conveyed – multi-lingual labels would be required for a global trial; either printed in a multi-page booklet or separate labels for each language. Where lots of information needs to be conveyed on a small package or container, specialist peel and reveal labels, wraparound labels or flag labels may be the best solution
  • Storage conditions – many medicines need to be stored in a cool environment, or even frozen for a period of time, so it’s essential that the label substrate, adhesive and print continues to perform whatever the environment
  • Possible contaminants – if the trial is conducted in a less controlled home environment it’s important that the clinical trial label can withstand possible contaminants such as grease, oil and water, and remain legible.

Consistency of label supply

As well as the requirement for high performance, if the clinical trial labels look and feel different across different drug packaging or different time scales, there is a danger that bias could inadvertently affect the trial. If a controlled, blind or double-blind trial is being conducted label consistency is especially important so that the control or placebo drug is not identifiable. Here are some of the ways we can ensure consistency:

  • Quality checks – cameras mounted on our printing presses check for minute colour and alignment differences in label batches and make automatic adjustments to ensure quality and consistency. Plus, cameras mounted to our label rewind machines can detect the smallest of differences to the label design; stopping immediately until the label has been removed and replaced.
  • Consistent label material supply – clinical trial labels can be produced in batches and held in stock until needed or label materials can be bought forward to ensure the same batch is used throughout the life of the trial
  • Label material trials – we routinely manufacture and test small quantities of clinical trial labels to ensure that the best possible materials, adhesives and techniques are specified to ensure optimum results
  • Tamper evident features – tamper seals are common in pharmaceutical labelling and alert any possible problems with the medicine. There are many different types of tamper seal; the right one for your clinical trial will largely depend on the primary packaging material
  • Blackout label materials – where primary packaging shows existing text or logos it may be necessary to ‘blind’ that detail avoid bias. Different types and colours of blackout label material are available to ensure that text is completely obliterated.

If you’d like advice on the right clinical trial labels for your trial speak to our experienced team.