REDUCING COSTS AND MAXIMIZING FLEXIBILITY WITH DRUG POOLING STRATEGIES

 In the complex and ever-evolving landscape of clinical trials, optimizing the supply chain is crucial to achieving success. One efficient clinical supplies management strategy that has been underutilized but holds significant potential is drug pooling. This approach can address several challenges faced by clinical supply chain managers, offering a more efficient, cost-effective and flexible way to manage clinical supplies. 

THE CHALLENGES OF CLINICAL SUPPLY CHAIN

Clinical trials today are global endeavors, often conducted in diverse regions with varying regulatory requirements and logistical challenges. Operating in diverse markets introduces complexities like managing multiple languages, sourcing local comparators, and navigating import/export regulations. These factors can strain timelines and budgets, making it imperative to streamline trial supply chain processes. The implementation of innovative strategies can greatly mitigate those complexities and risks.

UNDERSTANDING DRUG POOLING

Drug pooling involves maintaining open supplies availability for any patient, site, or study until they are needed. In other words, supplies are not allotted to any specific patient, site or study until the last possible opportunity. This flexibility allows for better allocation of resources, minimizing waste and ensuring that supplies are available where they are needed most. Drug pooling can be done at either the depot level, where supplies are centrally stored and distributed as needed, or at the site level, where supplies are kept undedicated until required for specific patient, site, or study needs. 

BENEFITS OF DRUG POOLING

Implementing a pooling strategy offers numerous benefits. Reduced risk of stockouts ensures that supplies are available when and where they are needed, avoiding delays in patient enrollment and treatment. This leads to significant cost savings, as it decreases the overall amount of drug needed, reduces waste due to expiry, and simplifies logistics and shipping processes. 

Moreover, pooling enhances flexibility, allowing for quick adjustments to supply allocations based on changing trial dynamics, such as enrollment rates and dosing requirements. For instance, in a Phase III program with multiple trials and numerous sites, pooling supplies at the depot level can significantly reduce costs associated with manufacturing, labeling, and shipping. If site-level pooling is also implemented, the cost savings and logistical efficiencies can be even greater, as supplies can be dynamically allocated to meet real-time needs. 

KEY ELEMENTS FOR IMPLEMENTING DRUG POOLING

To successfully implement a drug pooling strategy, several critical components are required. First, having a common supply platform is essential. Standardizing dosage forms and packaging enables supplies to be used across multiple protocols. Additionally, effective label design is crucial, involving strategies like multi-protocol labels or just-in-time labeling to meet regulatory requirements and maintain flexibility. 

 A robust Interactive Response Technology (IRT) system is also necessary for a successful pooling program. The IRT system must be capable of managing pooled supplies, tracking allocations, and ensuring regulatory compliance. It acts as the central hub for decision-making, determining when and where supplies should be allocated based on real-time needs. 

BARRIERS TO POOLING

While pooling offers substantial benefits, it is not always the right solution. Situations where pooling may not be advantageous include trials with no overlap in sites or significantly different protocols, highly predictive demand where the additional complexity of pooling may not provide sufficient benefits, or low-cost supplies where the cost savings from pooling may be minimal compared to the effort required to implement the strategy.  

Additionally, regulatory hurdles and the need for precise tracking and documentation can complicate the pooling process. Logistics challenges, such as coordinating supply shipments and managing varying storage requirements, can also pose significant barriers.  

Furthermore, the need for advanced technology systems to support real-time inventory management and the potential for increased initial setup costs may deter some organizations from adopting a drug pooling strategy.  

LABELING STRATEGIES FOR POOLING

Labeling is often cited as a barrier to pooling, but various strategies can be implemented to facilitate pooling, and to ensure compliance with regulatory requirements. One effective method is the use of multi-protocol labels that list all potential protocol numbers, allowing for flexibility in supplies allocation. Just-in-time labeling is another approach, applying protocol-specific labels just before shipment or dispensation, thus reducing the need for pre-labeled, protocol-specific supplies.

A POWERFUL CLINICAL SUPPLIES STRATEGY

The evidence shows drug pooling represents a powerful, yet underutilized tool in clinical supply chain management. By adopting this approach, clinical trial sponsors can achieve greater efficiency, reduce costs, and ensure timely and accurate patient dosing. As the industry continues to evolve, embracing innovative strategies like drug pooling will be essential for maintaining the pace and success of clinical trials in a competitive global market.  

Interested in learning more about drug pooling tactics? Check out our webinar, “Drug Pooling: An Untapped Clinical Supply Chain Strategy,” here.