The Challenges of Trial Supply Management

Clinical trials are expensive, and the investigational medical products (IMPs) are one of the important elements in the cost.

 

The complexity comes from many aspects starting with the labelling that needs to meet the different country regulations, the numerous interferants (Sponsor, distributors, sites…) for which supply visibility is mandatory, the temperature control requirements with quarantine management, and the forecast of the product quantity that needs to be manufactured and stocked at depot or at clinical site.

RTSM solutions allow tracking and managing the drug supply. They allow integration with distributor’s applications (PCI, Catalent…) to ensure a better visibility and control. They offer T° excursion management tools as well as accountability features and support country specific labelling to ensure the right labels are shipped to the right countries.

One challenge remains related to site supply and resupply. Shipping the optimal drug quantity to avoid supply shortage and overstocking at the same time may quickly become a complex exercise where different aspects must be considered:

Complex study designs greatly impact the drug supply management. For instance, resupply quantities should not be considered for discontinued participants or discontinued treatments. Previous dosing (titration, weight-based…) should be considered to predict upcoming dosing’s. Parallel dispensing schemes for IMP and companion drugs may require differentiated resupply arrangements. Last example affecting the supply are protocol amendments that may require additional treatment groups, additional visits, additional countries or different drug packaging.

Initial and resupply quantities will differ between high- and low-enrolling sites. Predictive resupply, based on the number of enrolled participants, is one of the approaches RTSM solutions take. The advantage of considering the enrolled participants is the fact that the treatment group is known, each treatment can thus be optimally resupplied. Unfortunately, this does not consider registration peaks. Other approaches like kit-level resupply settings or buffers can then be applied. They can also potentially align with the variable number of screened participants.

 

A third element to consider is the cost of the IMP. When the drug is expensive to manufacture, sponsors prefer avoiding overstocking and prefer just-in-time shipments. This approach requires a close look to the available stock at site to avoid that participants must reschedule or worse must come back because their treatment is not available. These kinds of misadventures impact the participant retention and may delay and increase the total cost of the trial.

One need to balance the cost of the drug with the cost of the shipping. When shipping is expensive (temperature-controlled shipments, Asian sites…) it might be preferable to ship higher quantities to reduce the number of needed shipments. Some sponsor may also prefer regrouping shipments to reduce cost and reduce CO² footprint.

The optimal at-site quantity will also depend on the drug expiry dates. Sponsors will avoid over-producing and over-stocking when expiry dates are short. Same when drug is manufactured based on biological samples (marrow bone…). In such case, one may prefer pre-ordering the drug and plan next participant visit based on the manufacturing and shipment lead-times.

 

 RTSM solutions offer different tools allowing sponsors to manage their supply chain, proposing basic floor-ceiling kit-level controls, providing more advanced predictive supply algorithms or even modeling the resupply by using trial supply optimization tools. RTSM solutions complement this trial supply management with reporting and alerting capabilities improving supply visibility and with integration possibilities with distributors’ platforms to provide a clear, faithful, and real-time situation of their stock and supply.

 

 With over 20 years’ experience in RTSM, IDDI advises sponsors in defining the best supply/resupply strategies. Our RTSM specialists propose the optimal scenario, and through our partnership with Sitero, configure their Mentor RTSM solution to meet sponsors requirements, ensuring that enough stock is available for site visits while reducing inventory and shipment costs and improving participant retention.