Two years ago, a good portion of the U.S. population did not know what a supply chain was. Today, with stores shelves empty and inflation rising, it's safe to say we know now. Supply chain issues are having a negative impact on clinical trials too. These issues result in increased costs, reduced productivity, decreased patient retention, and ultimately threaten the success of a clinical trial. There was never a better time to take a good, long look at how we can improve our clinical supply chain management.
Many dynamic, moving parts go into the execution of a clinical trial. For example, the protocol design, protocol amendments, patient visit schedules, different procedures at different timepoints, IP, lab kits, clinical supplies, biological samples, and shippers.
There are a variety of stakeholders that keep everything moving—clinical operations teams, clinical research sites, IP suppliers, supply vendors, couriers, labs, and auditors. And each stakeholder’s staff has varied working hours and responsibilities beyond any single trial.
All of this takes significant coordination and creates logistical challenges that make it difficult to ensure sites are prepared for patients. It is no wonder issues arise such as sites not having the study drugs needed for a patient, expired lab kits, lost biological samples, and delayed resupply shipments.
Any initiative to optimize clinical supply chain management should address four key areas—compliance, traceable chain of custody, real-time visibility, and stakeholder collaboration.
Today’s clinical trials are increasingly complex. One study found that today’s clinical trials require 70% more procedures, 85% more endpoints, 88% more data points collected, and 60% more research sites. This complexity is amplified by the fact that protocols are dynamic. Another study found that 60% of protocols require one or more amendments, the average protocol has 2.3 amendments, and each amendment requires an average of 6.9 changes to the protocol.
This complexity creates confusion among research site staff and leads to biological samples that can’t be submitted for laboratory analysis. By embedding the protocol and its amendments into clinical supply chain management processes, workflows are streamlined, productivity increased, and protocol deviations reduced.
Biological samples are the most valuable assets that travel across a clinical trial's supply chain. But an over-reliance on manual coordination leaves clinical operations teams disconnected from all the steps in a clinical supply chain where different stakeholders take possession of IP, lab kits, and biological samples during their collection, routing, analysis, and reconciliation. Automating this process will increase valid samples, productivity, and meaningful data.
As the complexity of clinical trials increases, so does the amount of data and the number of data silos. Even though clinical trials generate data as their end product, trial records are kept in multiple spreadsheets, databases, and paper records, in various formats, and updated in different ways. Combining or reconciling them takes time, manual effort, and expertise that is not often available. Providing every stakeholder real-time visibility into the location and status of everything involved in the trial—in the form of a single version of the truth—should be a focus of any clinical supply chain optimization effort.
For a successful clinical trial, all the stakeholders—sponsors, sites, CROs, laboratories, vendors—need to collaborate and coordinate their efforts. An optimized clinical supply chain will have a standard operating procedure for procurement and communicating when supplies have been ordered, shipped, received, and stored and when shipping regulations, schedules, and requirements change. Automated emails, notifications, and alerts go a long way in keeping everyone productive, making cost-effective decisions, and knowing how to get what they need when they need it.
I urge those conducting clinical trials to start a clinical supply chain optimization initiative before we find our shelves empty and our costs prohibitive. The knowledge, tools, and technology exist.