Just-in-Time labeling may now seem old hat. It is by no means a new concept with many advantages that have been heavily discussed. So why are more trial sponsors not taking this perfect approach (albeit on paper) to clinical supply labeling?
Before we answer that question, let's address the advantages.
Trial design has become ever-more complex; the product classes and geographical reach being dealt with in many clinical trials mean that greater flexibility in your clinical supply can make a real difference to your timelines and costs. Whether you are conducting adaptive trials, multi-arm trials, or juggling multiple trials and protocols for one single product, the clinical trial process is becoming ever more convoluted.
Throw into the mix the current rise in the production of biologics alongside the increasingly global reach of clinical trials and suddenly the process seems overwhelming. Therefore, adopting a Just-in-Time labeling approach to handle these varying factors lowers the risk of uncertainty, leaving you to worry less about the inevitable waste you will be faced with. That in turn enables you look to other aspects of your trial supply that need attention.
Additionally, with a large number of trials now conducted in Latin America, for example, the option to pool your clinical drugs in a free trade zone, such as Uruguay, ensures companies can potentially face minimal hassle. From there you can implement Just-in-Time labeling and distribute your products after adding your booklet labels. In this case, Just-in-Time labeling can substantially aid you in tackling the complexities of geographical imports and regulations.
Furthermore, as "postponement" is now emerging in clinical trials, Just-in-Time labeling will move beyond a 'nice-to-have' luxury to a necessity as product differentiation is delayed until the time an order is received. The benefits associated with delayed differentiation are along the same lines as those found in Just-in-Time labeling - a greatly reduced inventory, vastly improved flexibility resulting in significant waste reduction and a big drive for profitability.
Of course Just-in-Time labeling is not for every scenario. This is not a fail-safe to ensuring that you will never have to worry about excessive waste or delays again. For example, in blinded trials, or those with very rapid enrollment, this would not be helpful. There are four main points to consider when debating the use of Just-in-Time labeling:
- What are your screening and enrollment requirements? Are you conducting a study with rapid enrollment?
- What is the complexity of your trial? How many are you conducting? What is the value of your product? Which geographies are you going to and what is the regulatory environment? What is the shelf life of your drug?
- What kit design do you have? How big is the surface area?
- Are you making use of electronic systems like IRT?
So when is it advantageous to use Just-in-Time labeling?
- When your site selection is in flux
- When the retest period is short
- When there are additional protocols planned
Ultimately, while Just-in-Time labeling is not a new idea, the complexities, and in some cases fear of the unknown, mean that adoption has not been as rapid as to be expected. Just-in-Time labeling could be the best companion for your clinical trial and if it seems like a good fit the benefits you'll reap will be a huge helping hand when it comes to the big two: your financials and your time.