Adaptive trials are a hot topic of discussion around Fisher Clinical Services these days as we are starting to see an uptick in their use. This approach does pose additional challenges for a clinical supply team that must be considered. These trials need to be approached very differently than the traditional protocols. Traditional inventory management techniques won’t work and we need to determine a balance between making sure there is enough of the right medicine at sites while minimizing the overproduction of expensive medications.

For example, our planning needs to take into account the potential adjustments to quantities, treatment arms, or randomization. We need to stay closely connected to the forecasting data and plan for the ability to adjust given different sets of scenarios. A critical challenge is planning to ensure the medication for the next cohort is at the site in a “just in time” manner.