Packaging is an important component of successfully getting a drug ready for its clinical trial. While there are a number of regulations surrounding drug packaging and labeling, packaging specialists have one of the most creative roles in the clinical trial industry because of unique and specific packaging needs. In this article, we break down the five most important aspects of packaging clinical trial drugs.
- Storage: Every clinical trial drug requires a specific temperature environment. At Bay Area Research Logistics (BARL), we have on-site storage solutions that allow us to keep any drug at its specified temperature requirement with appropriate packaging and labeling materials. It is also important to ensure that a clinical trial drug’s temperature is not compromised during transport by using the most compatible solutions.
- Labelling for Blinded Studies: When it comes to blinding a study, it’s important to pay the utmost attention to labelling details. Make sure that the active and placebo drugs have identical expiry dates and lot numbers. Some sponsors make the mistake of labelling all active samples with a lot number beginning in 1 and all placebo samples with a lot number beginning in 2. The expiry date on both active and placebo samples should also be identical. It is also important to properly re-label commercially available drugs that are being tested for new treatments. Missing tiny details such as these can unblind a study, resulting in time and drug wastage.
- Dosage Adherence: Packaging should be designed to coordinate with study visits so that patients are not given an overwhelmingly large supply of the drug, and those administering should always have an adequate emergency supply on hand. Patient demographics also need to be considered. If patients fall into an older demographic, labeling needs to be larger and numbers like 6, 8, and 0 – which are easily mistaken for each other when using a smaller font – need to be clearly marked. If a study comprises of two or more drugs taken concurrently, different bottle sizes and label colours should be considered to clearly differentiate the medication.
- Reduce Wastage: We recommend packaging clinical trial drugs in relatively small numbers if possible. If a trial requires 12 bottles of pills to be taken over the course of 12 months, packaging all 12 bottles in the same kit could prove wasteful. Patients could drop out of the study after the first month, resulting in their entire years’ worth of the drug as well as the supplies used to create the kit being wasted. If a drug is distributed in smaller packages, fewer dosages are wasted if a patient leaves a study prematurely. This also saves time and resources at the end of a trial or if a patient completes a study when unused dosages need to be counted. It is far more efficient to count one month’s worth of pills than it is to count one year’s.
- Don’t Underestimate the Packaging Process: Drug packaging should be considered, discussed and planned from the beginning of any trial’s development, not at the eleventh hour before the drug needs to be available for the trial. Every country has their own minimum requirements for clinical trial drug packaging and factors including language, sponsor information, and international shipment all need to be dealt with at a primary level. If the trial requires actives and placebos, additional labeling decisions will need to be made. Each clinical trial is unique, and while clinical trial drug packaging specialists approach each case systemically, adjustments and customizations should be dealt with proactively from the primary protocol stages of trial development.
At BARL, we take pride in developing drug packaging as unique and specialized as your clinical trial. Make sure you contact a BARL representative today to learn how to de-risk your clinical trial through our expertise in labeling and beyond.