The need to collaborate with internal and external teams for a trial to be successful isn’t a new idea or concept. However, we still see the detrimental effects of a lack of communication between organizational teams; this is particularly true when the clinical operations team fails to communicate with the supply chain and logistics team about upcoming changes. Understanding how decisions made by one group ultimately impacts other groups is important for conducting a successful clinical trial.
Let’s use a global trial with sites in Brazil as an example.
Originally, two patients were to be enrolled per month at each site. This was updated to five patients per month at each site by the clinical operations team but without any communication with the supply chain and logistics teams. What were the effects?
The supply had been carefully managed for delivery to the depots so that the drugs were available to the sites per the enrollment plan. Based on the supply team’s forecasts, the logistics team had considered the import and customs requirements as well as the shipment duration to make sure that enough drugs were available, while also considering the drug’s shelf life.
With an additional three patients per month across all sites, supplies were sent to the sites quicker than expected, and the depot supplies were depleted, without the ability to immediately restock, ultimately placing the trial at risk.
It’s not as easy as just ordering more drugs when needed. There are a number of considerations to make when determining if/when to add more sites or increase enrollment. I’ve mentioned the import/export and customs requirements already, which vary by country and can add significant time to the entry of drugs into a country. This is in addition to the length of time to transport the drugs from the root depot. The depots’ capacity for storage and distribution constraints can limit the amount of drug available to the sites at a given time, and specific transport requirements must be managed within each country and region’s infrastructure.
In global studies, we need to be aware of holiday shutdowns (e.g., summer European shutdown, Carnival in Brazil and other countries, Christmas and New Year’s) that can shut down the supply chain to the sites during their duration. Each site needs to have enough supply to last the entire shutdown.
The supply chain and logistics teams are your in-house experts, with the knowledge required to help figure out how to effectively manage changes in trial. Understanding what a change in enrollment or the addition of sites in a given country does to the overall study drug demand is key to knowing how to minimize the risk of negative effects on the trial. Cross-collaboration with these teams and inclusion of key team members during meetings affecting drug supply and transport can reduce headaches later and ensure that you have the drug you need, where and when you need it. How is internal communication handled at your company? Are teams still siloed? Or are there open discussions and collaboration? How did your company transition from working in silos to working collaboratively?
Want to learn more about Bioclinica’s Supply Forecasting and Optimization Solutions? Contact me at firstname.lastname@example.org.