Commentary Contributed by Henk Dieteren and Lisa Li, Suvoda 

February 23, 2024 | Clinical trials have experienced tremendous innovation in the last few years. The introduction of new technologies such as wearable devices, machine learning, remote monitoring, and virtual clinical visits holds tremendous promise to expedite therapeutics to market and reduce the cost of clinical trials. This goal is important, as the costs associated with bringing a new drug to market have increased a staggering 140% over 10 years alone.  

In addition to these new technologies, it’s important not to overlook how current interactive response technologies (IRT) systems can be innovated and leveraged to manage expenses in one of the most costly aspects of clinical trials—the drug supply chain. Effective supply management throughout the drug development process can yield substantial cost savings, with estimates ranging from 15 to 20%.  

Untangling a Complex Web

The drug supply chain is a complex web that spans manufacturing, sourcing, logistics, and the management of unused medication. It’s further complicated by the unpredictable nature of clinical trials; the number and location of trial sites, participant enrollment at sites, participant variables, and withdrawal rate. These are all examples of some factors that impact drug supply forecasting (prior to trial start) and drug supply maintenance (during the course of the trial). 

To illustrate, a pediatric study that included participants aged newborn to 18 years in multiple locations required the initial shipment to include all treatment doses for a weight-based study considering worst-case scenarios and the uncertainty of which doses were to be assigned first. Only 6,000 kits were needed out of the 55,000 kits that were shipped, with the remaining kits destroyed.  

To identify how the drug supply chain can be optimized, it’s important to understand how each of the components of the supply chain contributes to overall costs. 

Manufacturing costs constitute a significant portion of clinical supply expenses. Without accurate predictions, study teams risk overestimating the number of kits required for a study. The surge in the use of expensive biologics in clinical trials accentuates the importance of meticulous forecasting as these therapeutics often are more expensive to produce and require special packaging, and intricate kit design, labeling, and assembly. 

Likewise, comparator sourcing, standard-of-care (SOC), or adjuvant therapies from the open market can be prohibitively expensive. A Tufts CSDD report revealed that the top 10 pharmaceutical companies collectively spend over $20 million annually on comparator sourcing. Study sponsors often pay retail prices, resulting in therapies accounting for a substantial 40 to 50% of total supply costs for a study. 

The growing globalization of clinical trials also introduces added complexity and cost. Multi-site trials across national borders often encounter high import taxes and complex shipping logistics, particularly for drugs requiring a cold chain. The global spending on biopharma cold-chain logistics is projected to reach $21.3 billion in 2024, emphasizing the need for better drug forecasting. 

Finally, many drugs have a finite shelf life. Those that have expired, along with excess drugs, must be destroyed. The cost of drug wastage includes all of the manufacturing and logistics costs, as well as the added cost of destroying unused medications. It’s estimated that 20-25% of investigational medicinal product kits can be wasted due to poor forecasting and planning, which may prevent companies from meeting Environmental, Social, and Governance (ESG) goals. 

Advance Drug Optimization

To address these challenges, a dynamic IRT system with a robust drug optimization tool emerges as a powerful ally for efficient supply management.  

Tailored to a study’s unique needs, an IRT system can enable study teams to make real-time adjustments, for example to Do Not Ship (DNS) and Do Not Count (DNC) values, even at the country level. This helps to prevent unnecessary waste and optimizes drug availability based on variable shipment times and shelf-life requirements at the country level. IRT systems also need to allow for control at the visit level to optimize expiry needs, especially for studies with variable visit schedules. Using a dynamic configuration resulted in $6 million in savings—about a quarter of the total supply budget—for one study. 

Traditionally, drug supply strategies have relied on static quantities of initial drug shipments and buffers, often leading to excessive orders to ensure enough medication is available during a trial. Buffers create average upper and lower limits for medication stock at all trial sites and automatically trigger medication orders if supplies hit the low limit. 

When used in combination with drug buffers, predictive algorithms can help drug supply managers fine-tune their supply strategies by creating advanced rules that factor in enrollment variables, such as participant weight, projected screen failure rates, and treatment titrations. The result is a more granular and dynamic supply forecast.  

Of course, technology must be paired with good planning and processes that include trial design decisions that prioritize the scientific integrity of the study while balancing supply and cost considerations.  

As the saying goes, the devil is in the details. The better the drug supply manager can control the relevant details of the most efficient supply chain in IRT, the better the results in waste reduction and cost savings. By utilizing innovative tools that enable more precise supply strategies, drug supply managers can better optimize supply to ensure the medication is available for patients who need it, when they need it, and can reduce the environmental impacts associated with manufacturing, packaging, and shipping site drug supplies.  

As the pharmaceutical industry navigates the challenges of rising clinical trial costs and the need to make their companies more sustainable, the optimization of the clinical supply chain stands out as a crucial strategy. With the integration of advanced analytics and dynamic IRT systems, sponsors and study teams can make informed decisions to manage clinical supply costs, minimize waste, reduce their carbon footprint, and ensure the availability of life-changing drugs for those who need them.  

Henk Dieteren is a clinical trial supply consultant at Suvoda. Lisa Li is the director of IRT product management at Suvoda.