Clinical trial drug packaging doesn’t look like commercial drug packaging. After all, its main aim is to spotlight the drug’s usability and functionality, not sell itself it consumers
Creating a clinical trial packaging centre is difficult as it is associated with different products being packed for multiple clinical sites and markets. This requires that suppliers have a complete working knowledge and understanding of global regulations, the specifics of different study designs, and the inner workings of clinical trial protocols. Suppliers must ensure that the right packaging strategy is used for the right product (based on its requirements) and that the materials are distributed to test subjects correctly and expeditiously. This makes clinical trial supply packaging an important factor to consider when working on a study’s design.
To help sponsors make an informed decision, here’s our brief guide to clinical trial packaging.
What You Need to Know About Clinical Trial Packaging
When it comes to issues or surprises that could jeopardize a clinical study or delay your product’s development, you want to respond appropriately. To help you make the right choices, follow this quick guide.
1. Plan Well
Finding a reliable packager early in the trial process means they can advise sponsors as to how to overcome the challenges of designing and carrying out a clinical trial study.
An important detail of your packaging strategy is to determine precisely how the drugs should be distributed to trial sites. But don’t wait until you have this plan in place to contact your drug packager, as doing so can negatively impact the patient/user experience by limiting your packaging options.
For instance, in trials with a complicated dosing plan, patients could use a wallet with blister strips to help them remember when and how to take specific medications. But preparing these packs can take time, so the later this information is available to the partner, the more difficult it will be to use this option. With prompt and proper planning, trial staff and sponsors can overcome these challenges and avoid unnecessary trial restrictions.
2. Be Consistent
While the packaging for clinical trial drugs may seem simple (after all, it’s designed to appear generic), some aspects are more complicated.
First and foremost, it’s vital that the packaging ‘protect the blind’. This means that all the packaging’s aspects, from the smallest printed elements to their positioning and colour, should be identical across all products. Even the smallest variations are unacceptable. This is to ensure that the packaging doesn’t influence the trial in any way and contribute to the placebo effect.
For instance, research staff or an investigator may see a dark blue on some packages and a lighter shade on others. This may lead them to think they’ve figured out which boxes contain the placebo and which have the drug. This guesswork could negatively influence how staff interacts with patients. A physician might unintentionally ask the patient a leading question that influences their answer and affects the trial’s outcome. This is why it’s vital that colour consistency is maintained both during the initial production phase and with reorders.
3. Blinding Is Important
Customers typically receive clinical trial drugs from suppliers with the packaging often ‘blinded’ by being altered or redesigned to ensure patients or trial staff can’t spot any differences. This is vital in trials that compare the effectiveness of two different drugs; most often a new one with something already approved for consumers. Sometimes, an existing drug is packaged in a vial and may have distinguishing features such as a unique stopper shape or specific colour. This is why it’s necessary for the packaging to have a blinding effect to ensure all vials are masked and colour differences aren’t visible to staff or patients.
4. Consider the Study’s Size
The size of your clinical trial (i.e. the number of patients along with the necessary dosing) will determine your required supply.
To accommodate the trial’s needs, its enrollment rate should also be considered. This can help determine each shipment’s size and frequency. For instance, a clinical trial could have more than 5,000 participants, but this enrollment rate could trend up or down over the study’s life. This means the supply of drugs should be monitored to meet ongoing demand. Example: if you have 20 patients enrolled in your study’s first month, it doesn’t make sense to acquire materials for five hundred.
Sites that handle multiple studies with varying protocols will require that each product be clearly labelled and delivered at the precise right time. In such instances packagers who can execute just-in-time solutions for trials are especially useful as they can pack, label and ship drugs as needed and therefore maximize efficiency.
A major challenge sponsors of clinical trials face is changing requirements, as initial planning can go by the wayside. Having a reliable clinical trial packaging expert on your side means your packaging needs can be adjusted according to regulations. They also help sponsors avoid local issues that could impact your budget and trial timeline. Since no two trials are alike, flexibility is a major factor of your clinical trial’s success.