Study non-adherence is an ongoing problem surrounding clinical trials. Noncompliance drives up research costs and increases the time it takes new medicines to make it to the market. One study suggests that costs associated with noncompliance are as high as $1.5 billion by the time the investigational product (IP) is fully developed 1. Considerate IP packaging is one way researchers can attempt to control compliance 2. Here are three things to consider when deciding on your clinical trial packaging:
Design: Studies indicate that blister packages, or unit-dose packages increase patient compliance 3. In fact, calendarized blister packs increase clinical organization and facilitate IP intake by providing patients with a clear protocol schedule 4. Package design is especially important when considering your patient group. For example, senior patients find it easier to follow a clinical regiment with unit-dose packaging. This preference is even more pronounced if they must take more than one drug at a time, or if they are required to take the drug multiple times throughout the day.
Volume: The amount of drugs placed per package and delivered to the patient can influence compliance. Patients might feel overwhelmed with the volume of IP given to them during the clinical trial. For example, if the clinical trial is supposed to run for the duration of 6 months, rather than putting all 6 months’ worth of IP in one package, dividing the IP into monthly increments can facilitate adherence. Furthermore, controlling the volume of IP released to the patient decreases the costs associated with study attrition.
Instructions: Clinical trials are constantly growing in complexity, and although research protocol instructions are provided during the informed consent procedures, by the clinician and are part of the insert brochure that comes with the IP, World Health Organization (WHO) recommends placing regiment instructions on packaging when space permits 5. Product specific details and protocol instructions on the package reinforce information regarding IP administration, and allow the patient to feel at ease with the trial procedures.
At Bay Area Research Logistics, we work with you to design the best packaging solution to accommodate your clinical trial requirements. We have expertise in handling all types of investigational products, and can assist with complex temperature requirements, including cold-chain and frozen secondary packaging (for vaccines or biologics).
Contact us today to find out how we can help with your clinical trial logistics!
1 Czobor, P., & Skolnick, P. (2011). The secrets of a successful clinical trial: compliance, compliance, and compliance. Molecular interventions, 11(2), 107–110. doi:10.1124/mi.11.2.8
2 Boudes, P. (1998). Drug compliance in therapeutic trials: a review. Controlled clinical trials, 19(3), 257-268.
3 Conn, V. S., Ruppar, T. M., Chan, K. C., Dunbar-Jacob, J., Pepper, G. A., & De Geest, S. (2015). Packaging interventions to increase medication adherence: systematic review and meta-analysis. Current medical research and opinion, 31(1), 145–160. doi:10.1185/03007995.2014.978939
4 Boeni F, Spinatsch E, Suter K, Hersberger KE, Arnet I. Effect of drug reminder packaging on medication adherence: a systematic review revealing research gaps. Syst Rev. 2014;3:29. Published 2014 Mar 24. doi:10.1186/2046-4053-3-29
5 World Health Organization. (n.d.). Annex 9: Guidelines on packaging for pharmaceutical products. Retrieved from https://www.who.int/medicines/areas/quality_safety/quality_assurance/GuidelinesPackagingPharmaceuticalProductsTRS902Annex9.pdf.