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4G Clinical


5 Supply Chain Impacts Resulting from Master Protocol Amendments – And How to Prepare


Protocol amendments can create a ripple effect on the supply chain, especially within master protocol oncology studies. Imagine you are starting a dose finding study with multiple combination therapies, which by definition uses two or more IMP for each. On top of that, you have numerous cohorts testing the effectiveness of each dose – and it could even be across different patient populations. As you transition to dose expansion with the recommended dose, the supply chain “ripples” again as cohorts are added to test different tumor types.

Now imagine again that you added new countries to the mix, started to pool supplies or add depots. The complexity of the supply chain is directly impacted by the complexity of the master protocol. It is critical that sponsors not only focus on the change itself, but the downstream impacts of that change, in this case – the supply chain.

Let’s dive into 5 supply chain impacts resulting from Master Protocol Amendments:

1. Redistributing Existing Supply

As changes are made to the protocol, many times supply managers need to redistribute existing lots to added regions/countries. If a new label is needed for that lot, it adds another element of complexity to get the supply to the right sites. The ability to sublot within the RTSM helps manage the re-label effort to specific regions.

2. Updating Supply Network to Support New Countries 

When new depots are added to the study, the integrations between the distributors and the RTSM need to be updated. How quickly or seamlessly those integrations are implemented can be critical to managing supply.

3. Different Supply Forecasts for Each Cohort 

Each cohort may have different supply projections. A dynamic RTSM can see which cohorts are open and project demand that is specific to the current status of the study.

4. Projecting Demand - Seeding Cohorts Before They Are Open

Often during dose escalation studies the demand will change as the dose increases, and you may need simply more kits or even a different configuration of kits. The ability to project cohort-specific demand outside of the current cohort status will give you that control.

5. Minimize Waste of Expensive Comparator/Combination Therapies

Many oncology studies include IMP from other companies, which can cost an arm and a leg. Amendments can change the kits to be dispensed, the doses to be used, the frequency of dosing…the list goes on. A system with robust forecasting capabilities will allow you to supply sites with precision, reacting the changes in your dispensing schedule, by doing the math for you.

Complex oncology studies like Master Protocols are critically dependent on a modern RTSM for the flexibility and agility needed to adjust as the study progresses. It is also just as important to look for a solution that has integrated forecasting to dynamically manage supply chain impacts.