Rethinking Drug Procurement in Clinical Trials: Hedging Against Unpredictability

Rising global costs, tariff volatility, and increasingly complex study designs have sponsors reevaluating how they approach one of the most fundamental aspects of trial execution: drug sourcing.

Based on patient enrollment projections that rarely materialize, traditional sourcing models require bulk-purchase of comparator and commercial drugs upfront. This approach results in overages, waste, and sunk costs in inventory that will never reach a patient.

About 80% of clinical trials are delayed due to difficulties in patient recruitment, a challenge that continues to impact timelines and cost efficiency.
Source: Tufts Center for the Study of Drug Development. “Tufts CSDD Impact Report 2013: Study finds nearly 80 percent of clinical trials fail to meet enrollment timelines.”

In today’s environment, a traditional sourcing model no longer makes sense for some clinical trials.

The cost of over-preparing

Clinical trial budgets are being stretched by external pressures, including the recent proposal to impose U.S. tariffs on pharmaceutical imports from key countries like China, India, and Ireland. Sponsors continue to pay for drugs they may never use – protocol changes, site variability, and enrollment barriers all contribute to stock overages.

The inefficiencies aren’t hypothetical either. In a recent study supported by Myonex’s CTRx™ solution, actual enrolled patients compared to enrollment projections dictated a drastic difference in drug and total project costs. Under a traditional bulk model, the sponsor would have paid for all estimated doses up front with no insurance measure in place. Instead, with CTRx, the sponsor only paid for the dispensed drug, ultimately reducing the drug spend from $1.78m to just $556k – a savings of over $1.2m.

Demand for solutions like CTRx is only growing. The global comparator drug sourcing market is projected to increase from $1.34 billion in 2024 to $1.88 billion by 2030, underscoring the shift toward more strategic, cost-conscious procurement approaches across the industry (GlobeNewswire, 2025).

Sponsors and CROs should regularly evaluate their procurement strategy. Drug costs are not a single line item – other monetary impacts are associated and often overlooked.

Key Considerations Include:

• Total cost of unused drug tied to forecasted but unrealized enrollment
• Additional costs driven by drug resupply or stockouts due to outdated forecasts
• Operational burden of discarding expired inventory

According to insights shared by the Tufts Center for the Study of Drug Development (CSDD), as much as 40% of comparator drug supply in clinical trials may go unused. This not only reflects significant cost waste but also underscores the logistical burden of managing overage – from labeling and cold-chain storage to regulatory compliance and disposal.
Source: Tufts Center for the Study of Drug Development (CSDD), industry insights shared via conference presentation, 2024

By shifting to a usage-based solution, CTRx allows sponsors to mitigate these considerations in their procurement strategy without compromising quality and speed.

If the past few years have taught us anything, it’s that resilience is only as good as your strategy. From COVID-era supply chain shocks to tariff threats and regional instability, sponsors are being forced to build strategies that can adapt with the ever-changing market.

CTRx as a solution-based supply strategy only adds to your resilience and reliability needed, reducing the operational and financial rigidity. CTRx gives sponsors more control and options, and fewer sunk costs.

In a market where drug costs are rising and flexibility is paramount, sponsors should ask themselves:
Are we paying for trial supply reality or for assumptions that never materialize?