Risk-awareness is a critical component of successful clinical supply management; you cannot fix the problems you don’t know about. We see clinical supply professionals overlooking the same key risks time and again. Let’s address them now.
Expiry dating
- One of the biggest impacts to the success of clinical supply management is expiry dating, particularly of the product itself. As formulation changes, further stability is required. Therefore, the stability testing sets the temperature range for storage and distribution and the expiry dating of the product.
- As a result, the clinical supply professional must balance limited expiry dating against making sure patients receive adequate drug supply.
- We see a lot of instances of requesting to package all of the supply of a drug in one go, without factoring in the expiry dates. This increases the risk of drug and money waste. When the sponsor doesn’t factor in expiration dates it?s also more challenging to monitor inventory and maintain stock.
- Also remember that, in general, 25% of initiated sites never recruit a patient. Drug volumes at that site are then lost as the result of a lack of recruitment and short expiry dates.
- When sites do have patients, make sure to factor in the patient’s dosing schedule when thinking about expiration dates, such as a run-in or wash out period that would not require investigational product.
Documentation
- Not having the documents required to import/export product can result in significant delays.
- In particular, there are certain import permits required that can cause drug waste if the shipment is sent without them in place.
Timelines
- It’s critical that sponsors understand the timeline of the packaging process, from scheduling patients in advance to clinical supply being available. Make sure you stress the importance of a well-planned timeline from the earliest stages of planning. Drug supply is often not considered until very late in the game. Patient recruitment, regulatory submission, etc are all critical, but drug supply and availability also need to be discussed early and made a cornerstone part of the planning process.
- If drug supply is not present, it has wide reaching consequences. For example, the clinical supplies team cannot prepare supplies without the bulk drug. There can be delays in the manufacturing and delivery of the bulk drug, as well as in receiving the data to support expiry dating and storage conditions. The supplies team will also need to know dosing regimens and requirements, country selection, data for interactive response technology, etc.
- Delays in any of these areas can result in the clinical supply team not being able to initiate any activities. And the clinical supply team is often the bottom rung on the ladder, and must absorb the often-accumulating delays filtering down from other functions. If you expect them to be able to deliver on time, these delays must be anticipated and planned for.
Quality and Regulatory Requirements
- We come across a lot of people who are naive about the clinical supply process and the approvals required for packaging a product. Inert fillers, capsules and other products all need to be validated product. If they’re not, it can have an effect on regulatory approvals.
- Our practice is to ask for a higher level of quality for the clinical trial, to ensure the highest level of quality overall.
- Sponsors and vendors need to understand how regulatory responsibilities are divided, and sponsors must factor regulatory approvals into their timelines.
Compliance
- We ensure there is a clear level of communication between ourselves and the sponsor around label, process, and facility compliance. There must be contingency plans in place across the board to ensure compliance is always achieved.
General Best Practice
- We make sure to support study initiation. In the case of large multi-country studies, we typically initiate with a single panel label as we go through the process of generating booklet labels, which allows flexibility in drug supply.
- The number of kits manufactured can be reduced to allow the study to initiate, but bear in mind this can impact budgets.
- It is not common practice to take all supplies and prepare as many as possible at the study start. This is especially true for large global studies, as it means that as expiry dating is updated, the labeled supplies must be relabeled. Packaged supplies also require more storage space, and therefore increased costs.
- Remember: logistics and planning play an important role in clinical supply involvement. Good luck!
