When a clinical trial progresses to later phases, there are significant considerations that can impact the packaging process. As the study scales in size concerns that may need to be addressed include packaging redesign, longer lead times, logistics challenges, increased risk . . . to name a few. By investing in some detailed up-front planning, we can mitigate the risk of unexpected impacts during the later stages.
What has the greatest impact when scaling clinical trial packaging?
- Multi-Language Support: Later phases of a clinical trial often include new countries / regions / patient populations. Additional languages need to be supported, and different regulatory requirements are in place. If there isn’t a well-designed process to support label translations and to obtain the required regulatory approvals, timelines can be significantly impacted. If there is a database with master label text, pre-approved translated phrases, and templates that address regulatory requirements the impact can be minimized. However, in the absence of this, the process will often take much longer than expected.
- Complicated Packaging Design: In the early stages of a clinical trial, sponsors are working with a small number of kits. A design that includes elaborate kitting techniques may be manageable in low volumes. When scaling into the thousands, issues quickly arise. What is the cost to produce in higher volume? Does the investigator site have the storage capacity as they expand enrollment? How does this impact shipping expenses? Using a simplified package design from the earliest stage of the trial will have a positive impact on overall shipping and packaging costs, as well as the required storage space.
- Risk Mitigation: With larger volume comes increased risk in the event of an unexpected outage. If a natural disaster causes a packaging facility to go off-line, how quickly can production be moved elsewhere so patients are not impacted? By working with a packaging supplier that has multiple facilities, they can manage capacity using their facilities interchangeably. To take full advantage of this capability it is important that the sponsor lists all sites on their application at time of filing, whether the site will be used or not. In doing so, it allows for a seamless production process that minimizes patient impact.
- Remote Global Locations: To meet enrollment targets, clinical studies are extending to include remote locations in emerging countries. Each location presents its unique challenges with respect to regulatory requirements and import/export timelines. If later phase trials are expanding to these regions, understanding these requirements is essential in order to factor sufficient lead time into the process. There may be value in working with suppliers with regional and/or in-country packaging capabilities to streamline end-to-end logistics.
- Changing Medication Delivery Device: If working with an injectable therapy, it isn’t unusual to use vials in the early trial stages. As the trial scales, and given better stability data, the sponsor might change the delivery device to a prefilled syringe or auto-injector. A critical consideration that guides that selection process is understanding who will administer the medication. Any change will introduce a unit cost change, as well as a start-up timeline to change the packaging production process.
- Product Shelf Life: As a study expands to include new countries, it’s important to understand that some mandate a minimal shelf life e.g. 6 months. This requirement can impact where and how often the product is packaged. In fact, if stability data isn’t well established, this requirement may even impact country selection. It might be necessary to firmly establish stability data before attempting to expand the study globally.
As with every aspect of a clinical trial, engaging with subject matter experts as early in the process as possible can lead to the best outcomes. Their expertise can help guide the team towards an optimal solution design that delivers cycle time reduction, pack design efficiencies, and better ways to manage the end-to-end supply chain.