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Investigator Initiated Trials (IITs) – Forecasting Strategy

Robyn Meissner

By: Robyn Meissner November 28 2017

Tags: Clinical Supply Optimization

Investigator Initiated Trials - Forecasting Strategy

Collaborative forecasting for a successful IIT

Forecasting strategy is usually an afterthought when managing Investigator Initiated Trials (IITs). It’s assumed that the Sponsor-Investigator will forecast their demand and provide timely updates whenever a resupply is needed. This situation is rarely the case due to a busy study staff, inexperienced Sponsor-Investigators, or sometimes lack of supply chain knowledge. It’s important to discuss the forecasting strategy with the Sponsor-Investigator before the IIT starts enrolling in order to capture the appropriate data throughout the study’s lifecycle. 

The supply chain team is responsible for developing a robust forecast for each IIT within the program. A good starting point in creating a forecast is to build assumptions around drug quantities, dosage and patient enrollment. Collaborate with the Sponsor-Investigator and the Pharmaceutical Company’s clinical teams for insight on drug consumption in these types of trials. 

Once the demand is forecasted for each trial within the IIT program, review the demand with the clinical team and consider ways to minimize drug waste while mitigating expiry issues. Pooling Supplies can be an effective strategy for an IIT program when trying to significantly reduce the quantity of supplies. Pooling uses the same product batch and packaging design across multiple protocols within the same program. The central depot can package in bulk across several protocols at once and then apply variable text on custom labels just in time for shipment to the sites. The supply chain manager can monitor inventory levels of the pooled stock and trigger a new campaign once a certain threshold is reached. Using a pooled strategy allows the supply chain manager to manage supplies across an entire program instead of managing supplies for each IIT separately. The Pharmaceutical Company can utilize fewer lots and recognize cost savings while easily matching demand.

Once an effective strategy has been put in place to minimize drug waste, it’s important to determine how enrollment information will be gathered for each IIT in order to know in advance the timing for resupplies and new packaging campaigns. Here are a few points to consider:

  • Receive updates from each Sponsor-Investigator on a consistent basis, i.e. monthly or quarterly
  • Ensure the Sponsor-Investigator and study staff are made aware of resupply and packaging timelines so they can fully understand the need to provide a regular update
  • Create a monthly enrollment form for the study staff to complete on a regular basis. Include information such as:
    • enrolled vs. ongoing patients
    • number of screen failures
    • upcoming protocol amendments
    • updates to study timelines
  • Use the completed form to adjust the forecast as needed 
  • Keep a record of the enrollment history and challenges of each IIT in order to analyze trends in study enrollment and drug consumption when forecasting for future studies
  • Discuss the plan for gathering enrollment information upfront with the Sponsor-Investigator 

Forecasting will always play an important role when managing an IIT Program. Forecasting demand, finding ways to minimize drug waste, and continuing to gather information throughout the IIT program will ensure there are finished goods available whenever the Sponsor-investigator submits the next drug order.

Click here for more top tips on working with Sponsor-Investigators on IIT Programs!


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Robyn Meissner