When conducting a clinical study, the need for clinical trial materials (CTM) cannot be overstated. For some, to carry out a trial without CTM is close to impossible. Certainly, it can be argued the importance of having ample trial supplies is integral to a study's success. Furthermore, regardless of a pharmaceutical company's size, to run low on CTM is detrimental to their supply chain resources.
Therefore, in order for a supply chain manager to be successful in CTM supply, here are three things they should consider:
1. Define Clinical Study Requirements
Once a study protocol has been established, ensure it is made available to help clarify supply needs. The supply chain manager must bear in mind a multitude of factors, such as the number of patients projected to enrol, predicted drop-out rates, the required dosage, the number of participating sites, and so forth. What's more, bearing in mind the duration of the study is critical in evaluating your CTM needs. This would help the team understand what shelf-life or expiry issues there may be or it could support the use of a single-lot of material throughout the course of the trial. Failure to define such parameters could lead to over or under production of product and have a significant bearing on spending.
2. Acknowledge Manufacturing Processes and Concerns
Long before a clinical trial begins, it is important sponsor companies understand the nuances of the clinical supply chain. Simply supplying CTM to a participating site can be complex, not to mention laborious, and that should not be forgotten.
What's important to determine is whether your company can develop the product internally or if it needs to be outsourced. Once that has been decided, sponsors need to identify if they have the capacity to meet the demand within a set time frame. Additionally, the sponsor needs to determine what is required to manufacture the product, whether the use of a scheduled narcotic API, for instance, would need special handling permits, and so forth. These are some of the factors a supply chain manager must consider as the CTM manufacturing process is assessed before a clinical trial begins.
3. Structuring Distribution Effectively
After you've established requirements for CTM and production has begun, it's necessary to change tack and assess other parts of the supply chain to mitigate financial impacts. More often than not, it's vital to understand what clinical trial supplies are distributed to sites as well as CTM. That could include diagnostic supplies, rescue medications, and lab kits, just to name a few. Each of these tools is important to consider when it comes to reducing the number of shipments for each site and to easing the burden placed on site staff.
Supply chain managers should consider the size and weight CTM kits so the impact on limited shelf space at sites are minimised. Also bear in mind the volume of product that would be required at each site. While supplying large quantities of CTM may appear conservative, if the site is unable to enrol enough patients that could incur losses that otherwise could have been avoided. Nevertheless, by not providing a sufficient amount of materials, it could hamper the site's ability to enrol patients. So a fine balancing act is required by the supply chain manager when it comes to ensuring a site is well stocked and resupplied with CTM.
*For a more in depth take on waste reduction and logistics in domestic clinical trials, read Jonathan Lindberg's article here.
Planning for success: Best practices for waste reduction and logistics optimization in domestic clinical trials - bit.ly/1M9K97C