- Phase III multi-center, double-blind, randomized, placebo-controlled study
- 150 patients
- 80+ sites across 25 countries
The sponsor was concerned that the following factors would cause a very high level of drug wastage:
- Large number of sites
- Clinical supplies team did not have the capacity to closely monitor sites
Calyx supply chain experts recommended Calyx IRT’s automated supply strategy management to:
- Ensure each site is appropriately stocked by changing the IMP supply levels to match current recruitment rate
- Take the burden off the clinical supplies manager
- Minimize drug wastage
Identify which sites are active
Assess the site based on defined parameters
Switch the supply strategy, if needed
Generate shipment specific to the site’s needs
What is a supply strategy?
Supply strategies determine what stock is sent to a site; they combine site needs for both:
- for randomization & for unplanned needs, for example, replacing damaged stock
- quantities based on assumptions made at the start of the trial
- typically, for subjects from randomization onwards
- quantities based on subject treatment group, dosing regimen & visit schedule
Typical IRT approach
When the site is first activated, a strategy is selected based on the expected recruitment rate; this can be changed by the clinical supply manager via the IRT whenever the actual recruitment rate differs, so requires active monitoring
Advanced IRT approach
Automated supply strategy management differs as a site’s strategy is automatically changed to align with its actual recruitment rate.
The automated supply strategy management process:
For this study, Calyx IRT ensured that all subjects currently in screening could be randomized (and for this design received 1 kit of active or placebo).
The stock in the initial shipment was based on a dynamic count of subjects actively in screening at the site
The stock in the resupply shipments was based on a dynamic count of subjects actively in screening at the site
The quantities to ship per strategy were defined based on assumptions at the start of the trial with the support of the study’s dedicated Calyx IRT randomization and trial supply expert. Clinical Supply Managers were able to amend those quantities through Calyx IRT self-service tools, once real-world patient and site data was available.
The Calyx IRT design also included:
- The option for the clinical supplies team to easily override the automated supply strategy switch via our inventory management web system
- Country-specific opt-outs for the automated process
- Specific supply strategies for locations with a long lead time for shipments
By using Calyx IRT to automatically optimize the supply strategy for the site’s current recruitment situation, the sponsor was able to:
- Relieve the clinical supply manager’s burden of closely monitoring each site’s supply levels against patient recruitment
- Avoid failed patient visits due to insufficient medication
- Ensure that each site is on the optimum supply strategy for their current recruitment rate
- Keep drug wastage to a minimum
More on automated supply strategy management
Automated Supply Strategy Management is one of Calyx IRT’s advanced trial supply management options; it’s a flexible approach that can be tailored to specific protocol requirements and supply criteria.
The approach can be helpful for any type of study but is particularly useful at reducing the burden on the clinical supply manager when there are many sites.
Trials which benefit most
Large trials with many sites
Trials with a combination of local and central sourcing of IMP
- The greater number of IMP types, the larger the possible combinations for resupply strategies
- Automated switching would be used to assign a strategy based on the source settings for a site
Comparator trials where the comparator is known to be different based on patient characteristics
- Automated switching could be used to monitor the level of comparator medication based on the number of patients with the required characteristic
Calyx RTSM expertise
Our dedicated IRT randomization and trial supply experts are here to help with any questions related to advanced trial supply management.
If you are interested in using automated supply strategy management, Calyx RTSM experts can assess the suitability of the method for your design considering:
- Number of sites
- Recruitment rates
- Supply of future visits
- Medication costs
- Medication availability