Contributed Commentary by Carol Alexandre, Lewis Prior, and Eduardo Tedeschi, IQVIA 

August 23, 2024 | In a post-pandemic environment, we know the emergence of another viral risk is inevitable. As such, the broader healthcare ecosystem has evaluated insights from drug development efforts in recent years to develop a shared focus on improving vaccine readiness and equitable access by populations of low-to-middle income countries, or “LMICs.”  

When we take a closer look at what healthcare stakeholders are doing to apply COVID-19-related knowledge to the next global health challenge, we find them working to help trial sites in LMICs prepare to operate effectively when the time comes and ensure a proficient local response with vaccine access.  

To become and remain prepared, the following key areas of investment for LMIC-specific clinical trial support have been identified as critical.  

Agile and Thorough Clinical Supply Chains  

When they encountered a lack of materials, reduced transportation options, staffing issues, and other challenges during COVID-19, industry stakeholders understood the critical nature of global supply chains and the importance of planning for the next public health challenge. We now recognize that an agile and robust clinical supply chain is more critical than ever for healthcare stakeholders who want to ensure vaccine access globally, especially in LMICs.  

Effective global supply chain management can be challenging, particularly in LMICs where clinical trials are increasingly complex, and there are unique regional challenges, such as lack of resources, expertise, and infrastructure, which can cause delays, potential treatment shortages and/or waste.  

In recent years, clinical trial sponsors, clinical research organizations, and other public health stakeholders have begun to address these challenges to optimize supply management strategies in these regions. The following solutions are being developed to ensure vaccine readiness in LIMCs.  

Cold-Chain Logistics  

One of the major challenges to conducting clinical trials and ensuring treatment access in LMICs is the condition of infrastructure and related logistics. From storage facilities for investigational products to transportation networks for drug distribution, the lack of infrastructure, particularly in remote or high poverty areas, can adversely affect treatment access. In many cases, trial sites are far apart, making it more difficult to store, transport, and distribute vaccines.  

Vaccines need to be stored and shipped at specific temperatures, often within 2°C to 8°C (36°F to 46°F). Certain vaccines (e.g., COVID-19) require ultra-low storage between –70°C and –80°C (–94°F to –112°F). Maintaining the required temperature range is crucial to ensuring their safety and effectiveness. 

Therefore, clinical trial sponsors and partners should plan to qualify and integrate cold chain experts into their plans to closely monitor and manage temperature-controlled vaccines and supplies. For some vaccines, monitoring for temperature control is necessary every 15 minutes. 

Related activities, including importing vaccines into LMICs, storing, and distributing between depots and sites, often over long distances, can prove challenging. Investments in cold chain logistics and related storage facilities and transportation networks in LMICs is critical. While there are still limitations in the local, regional, and national logistics networks across several LMICs, such as within Africa, there are several ways to mitigate these problems.  

Having a clear regulatory roadmap is essential to ensuring that drug products can be efficiently imported into specific countries. The responsibilities of the Importer of Record to ensure there is an appropriate import license for the initial country of import and for any ongoing product movements within the region are very important.  

Early planning and risk mitigation is key to ensuring that no delays occur during this key stage of the supply chain. Equally important is the identification and set up of logistics partners across the LMICs involved. For example, in Africa, common depot locations include Egypt, Kenya, and South Africa. While it is encouraging to see new depot locations, such as Ghana, slowly emerging, there remains a vast continent where supplies sent into a LMIC must go to specific clinical sites because there is no active depot in that country. Therefore, having logistics partners clearly identified and engaged with specific trial supply strategies as early as possible is key to successful trial outcomes in these developing regions.  

Drug Supply Management Technologies  

Being able to closely audit the trail of vaccine shipments from development to packaging, shipping and receipt, and to maintain the integrity of quality, temperature-controlled product requires trial sponsors, CROs, and related supply chain vendors to rely on tech-enabled support.  

Primarily, clinical supply chain managers use Interactive Response Technology to provide real-time views of inventory storage, dispensing, and shipping statuses. The IRT monitors these factors in relation to expected and ongoing patient enrollment activity to optimize the quantity of inventory stored and shipped between depots and clinical sites.  

IRT vendors have become more acutely aware of the need to reduce waste in recent years, which is likely influenced by the increase in cold chain therapies and long and costly manufacturing processes. Hence, some have introduced drug optimization tools to their platforms. Such tools offer significant efficiencies in drug waste reductions but also help improve patient retention by ensuring drugs are available on site when needed. There has also been an emergence of cloud-based temperature management solutions, which include GPS features, if needed, and are also integrated with IRTs. These solutions can automatically make disposition decisions if an excursion has occurred. This helps simplify site processes and mitigate missed dispensations due to time delays while awaiting decisions.