Clinical research supply chains ensure trial sites have the supplies needed throughout the study. This allows patient visits to occur without delays due to missing drugs, supplies, or equipment. This is an update to a blog post from last year: Clinical Trial Supply Chains: The Key To Avoiding Disruptions.
The COVID-19 pandemic was a stress test on supply chains. The Capgemini Research Institute’s 2020 Supply Chain Survey noted that, among other issues, 74 percent of organizations experienced delayed shipments/longer lead times, and 68 percent had products held up in ports or at borders.
While current supply chain disruptions are significantly lower than three years ago, they remain more than double pre-pandemic levels. The immediate impacts of COVID-19 have been mitigated for many organizations, but disruptions throughout the supply chain continue to create risk. In addition, levels of reported supply chain disruption have been higher this year, with 11.5 percent of respondents reporting at least 10 disruptions in the past 12 months. While this number is significantly less than the 2021 peak of 27.8 percent, it is still more than twice as high as pre-pandemic levels (4.8 percent).
Let’s explore ways to position your organization’s study supply chain to be less vulnerable to disruption.
What is a Supply Chain?
A supply chain is made up of all the participants in manufacturing and distribution channels. This includes the producers and logistics providers that move inputs from one stage to the next, along with wholesalers, distributors, and retailers who ensure products are available to the consumers who want them.
Supply chains are shaped by a complex network of relationships. These relationships affect the movement of supplies from place to place and also the incentives for companies to invest in producing new products.
Recent Changes to Supply Chains
Supply chains have become more complex, interconnected, and global than ever before. While the increased globalization of production has helped reduce consumer prices in the United States, it also means these supply chains are more vulnerable than ever to disruption. Organizations have seen a significant increase in the number of supply chain disruptions since 2020 compared to prior years.
While COVID-19 was the major force driving up the number of recent incidents, other events were part of recent major supply chain disruptions and can potentially cause future disturbances. These events include:
- Natural disasters
- Transportation disruptions in both container shipping and trucking
- Political instability and wars/conflicts
- Talent and labor shortages
- Rising costs
- Product discontinuation or supplier closure
Understanding how to promote quick recovery is increasingly important. It is also vital for companies to have the incentive to invest sufficiently to make their supply chains more resilient. This is vital even when they may not be able to monetize all the benefits of these expenditures due to spillovers to other parts of the networked system.
Supply Chain Issues
As networks become more connected, the frequency and size of supply-chain-related risks rise. To help mitigate the impact on production, organizations have had to:
- Reassess their supply chains to ensure product availability
- Review manufacturing models
- Stockpile strategic inventory
- Reduce reliance on just-in-time manufacturing
In addition to outsourcing or moving production overseas, companies hold less inventory on hand. Companies that had previously relied on acquiring goods quickly for a just-in-time manufacturing model have seen delays and, in some cases, the inability to deliver goods at anticipated or contracted levels. Some 25.3 percent of organizations reported that this had a major, serious, or catastrophic impact on their business. The BCI Supply Chain Resilience Report, published in January 2023, reported that 18.8 percent of suppliers are reassessing just-in-time manufacturing. While it is highly unlikely that just-in-time inventory models will ever truly be abandoned, the pandemic has fundamentally changed many of the assumptions around the ability to source quickly and efficiently. The most fundamental change relates to inventory stockpiling, with 29 percent of organizations reporting they plan to stockpile more goods as a result of supply chain interrupts, up from 19.6 percent in the June 2020 study.
Study Supply Chain Impact on Clinical Trials
By July 2020, almost 200 companies had stopped or delayed their clinical trials because of the pandemic. It’s estimated that about 80 percent of non-COVID-19 clinical trials were interrupted or stopped.
As with other aspects of the global supply chain, the COVID-19 pandemic impacted clinical research supply chains. As the pandemic continued, delays continued for months, and trials that were in progress were hampered as any inventory redundancies built into their supply chain eroded. Sustained, high-level supply chain shortages stretched across all areas of health care, with 8 to 10 times as many items in short supply compared to pre-pandemic levels.
While many of the governmental allocation restrictions have been lifted for medical ancillary supplies, there has been limited improvement in the availability of many study materials, particularly medical ancillary supplies, and equipment. The increase in study startups from studies delayed or canceled by the pandemic has created sustained high levels of demand for these items. This demand, combined with ongoing material shortages, problems with hiring and retaining labor across all industries, and rising material and capital costs for manufacturers, means there are fewer products available, and the time required to receive those products has greatly increased.
These factors, along with ongoing transportation disruptions, have increased the need for stronger supplier and courier relationships. Every delay, from equipment and supplies not arriving at a clinical site on time to patients being unable to complete their visit, creates an avalanche of effects. These effects can range from decreased patient retention to increased time to market.
Making Clinical Research Supply Chains Resilient
It’s important for the management team to focus on mitigating supply chain risk through supply chain resilience. Supply chain resilience is the ability of your organization to plan for, respond to, and recover from disruptions in a timely and cost-effective manner.
Practices to make your clinical research supply chain more resilient include:
- Understanding the structure of your organization’s supply chain
- Investing in backup capacity
- Diversifying your supplier base
- Improving the ability to substitute items
- Employing technology to analyze risk and reduce manual processes for managing the supply chain
The downside is that these strategies, especially redundancy, increase costs. Unfortunately, there is no cost-effective measure for your company to invest in to completely remove all risks from your study supply chain.
Strategies to Mitigate Risks to Clinical Research Supply Chains
There is no single optimal way to organize a supply chain, and even within the same industry, many companies will often choose different strategies. Some best practices to consider in mitigating your clinical study supply chain risks are:
- Business continuity planning – Your organization’s plan to continue critical business functions in the event of an unplanned disaster
- Diversification – Expand your network of suppliers and transportation affiliates
- Agility – The speed at which both product and decision-making shifts can occur
Business continuity planning that includes a focus on supply chain risk is essential to proactively identify threats to your study supply chain before they occur, so alternatives or relief efforts can be identified in advance. This planning should be ongoing and continual to have the best efforts at mitigating arising threats, and to meet the business needs as they change.
Diversifying your supplier base can also help reduce inventory shortages by creating a wider network of suppliers to provide goods and services. It is important to have a robust vendor qualification process to ensure new vendors are reputable, product quality is satisfactory, and inventory levels are adequate. Due diligence on all key suppliers is vital to ensure suppliers will meet the appropriate quality and safety standards and supply needs.
The more agility your organization has to:
- make purchasing decisions quickly
- prepare and source equipment early
- spot-buy strategic inventory as it becomes available
- approve new vendors
- select acceptable product substitutions
- build as much product and equipment flexibility into the clinical trial protocol as possible
…the easier it will be to navigate many clinical trial supply chain challenges.
Strengthening Your Research Supply Chain
While we’ve seen improvements to the supply chain over the past year, delays and disruptions continue at levels much higher than pre-pandemic, and sustained focus on strengthening relationships with key suppliers remains important. This, along with opening the doors to new suppliers, product flexibility, and contingency planning, will help you meet your ongoing demand for goods and services.
Imperial’s management team has made the resilience of our supply chain a priority and taken the needed steps to ensure continuity and avoid disruptions. We continue to focus on expanding our supplier network and mitigating risks to provide the products and services our customers need.
Van Dorn, A. 2020, August 22. COVID-19 and Readjusting Clinical Trials. The Lancet. DOI: https://doi.org/10.1016/S0140-6736(20)31787-6.