Most clinical trial managers outsource most of their supply chain activity (sourcing and producing trial materials, and the logistics of running the trial at sites). In addition, there is a trend toward direct-to-patient delivery, either from depots or from clinical trial sites. The practice is being conducted with 24% of trials today, and roughly a third of those not doing so today, expect to do so in the next 12—18 months.
These are the high-level conclusions from a just published study, Assessing the Current and Future State of Clinical Trial Supplies. Sonoco ThermoSafe, a thermal packaging-materials supplier, sponsored the study, working with Berlinger, a provider of temperature monitoring services, and Arena International, a conference company that sponsors clinical supply meetings. The survey is available at no charge at a Sonoco site,* and details of it will be presented at upcoming Arena meetings.
According to the 230 trial managers (working at drug developers, or at CROs or other service providers) polled, 61% of them spend more than 50% (53% to be exact) of their clinical supply-chain budget with outside providers. The survey breaks this down to six steps between sourcing raw materials and delivering finished goods; of those steps, the one from “drug substance to drug product” is the most challenging—just nosing out the final step “finished good to local depot.” That local depot step, of course, often involves international distribution, and the survey finds that a full 86% of trial managers use brokers (couriers, CROs, local depot managers, roughly in that order) to handle import regulatory tasks.
Respondents are mildly sanguine about clinical trial supply-chain practices, with almost half calling themselves “innovative” or “very innovative.” But challenges are recognized, especially around data collection and proactive management of the trial supply chain.