The High Cost Of Zero Waste: Protecting Patients In Clinical Supply

By Elisha Lowe, RN, BSN, MBA, IRL Life Sciences Partners

In 2026, the clinical supply chain is no longer a back-office function of boxes and bottles. It has become a frontline lever in an escalating financial and regulatory battle. Between the first cycle of Medicare price negotiations under the Inflation Reduction Act (IRA) and a broader industry-wide push for operational efficiency, supply teams are being pressured, implicitly and explicitly, toward zero-waste models.¹

Historically, the industry managed risk with volume through the safety-stock model. Today, industry analyses estimate that several billion dollars in annual clinical supply waste, once tolerated as the cost of certainty, are being aggressively eliminated to protect R&D margins.²

While IRA price negotiations apply to marketed products, the downstream pressure on capital allocation has accelerated internal demands for leaner trials across the portfolio. Through the lens of patient advocacy and clinical observation, a zero-waste logic is emerging that increasingly shifts operational risk onto patients.

The Margin Squeeze

Medicare’s first cycle of negotiated Maximum Fair Prices (MFP) resulted in discounts ranging from 38% to 79% for the first 10 drugs selected.³ This has forced sponsors to seek radical efficiency in late-stage development. To meet efficiency and zero-waste goals, some supply chains are structured around just-in-time (JIT) distribution and release, reducing inventory buffers at the patient level.

On paper, this works. Interactive response technology (IRT) enables shipment only when a patient is randomized. In practice, razor-thin margins leave little room for error. A kit damaged in transit has no backup. A courier delayed by 48 hours means a patient’s supply hits zero. This risk is compounded by increasing variability in last-mile delivery reliability across U.S. logistics networks.⁴

In a clinical trial, that is a protocol deviation that can compromise endpoint integrity, trigger costly remediation, or, in small-n trials, jeopardize the entire data set.

The Cold Chain Hammer

From a clinical observation standpoint, efficiency often dies at the patient’s doorstep. When a zero-waste kit sits on a porch and a temperature sensor flags an excursion, the drug may be unusable. In a JIT model, replacement is often not immediate.

This creates what many operations teams experience as excursion anxiety. A thin supply chain is not just at risk of being late; it is at risk of being invalidated by a single hot afternoon. Eliminating inventory buffers may reduce carrying costs but shifts the operational risk directly onto trial execution.

The Blinded Study Problem

Data integrity in blinded trials is an operational risk that receives far less attention than it deserves. Industry analyses of FDA Bioresearch Monitoring (BIMO) inspection findings consistently cite inadequate drug accountability among common deficiencies at clinical sites.⁵ When inventory is razor-thin, there is less tolerance for documentation errors, delayed reconciliation, or emergency resupply.

Minimal on-site stock can reduce some operational variables, but insufficient buffers increase coordination failures during urgent resupply, raising the risk of accidental unblinding. Sponsors need to understand which dynamic applies to their specific protocol before finalization, not after enrollment begins.

Lean supply models can also introduce subtle allocation signals that teams strive to prevent. In a blinded trial, uniformity is protective: kit availability, shipment cadence, and resupply timing all preserve the integrity of concealment. Removing buffers makes supply reactive, introducing more variability in shipment timing and reconciliation patterns.

Even when no formal unblinding occurs, perceived patterns can influence site behavior, reconciliation scrutiny, or escalation decisions. The risk is rarely dramatic, but it accumulates. Zero-waste models compress tolerance for small inconsistencies precisely what robust blinded design aims to eliminate. Evaluating reduced buffers for new variability is critical before trial launch.

The Fourth Burden

Trial participation already burdens patients with demands on time (travel, clinic visits), physical effort (procedures, side effects), and emotional weight (managing diagnosis, uncertainty). As zero-waste models gained traction, reusable shippers followed, not as patient-centric innovations but as cost-containment tools. What was once framed as sustainability has become an operational necessity.

The shift toward reverse logistics effectively outsources operational coordination to the patient, a systemic hand-off that assumes physical and cognitive labor often at odds with the patient’s condition. Younger urban patients may adapt, but older or rural populations face documented barriers to adherence and retention.⁶ Sponsors must audit patient populations before designing reverse-logistics workflows and avoid assuming uniform capability.

What You Can Actually Observe And Act On

While the IRA creates the pressure, the strategic response lies in how sponsors manage the resulting volatility.

Maintaining trial integrity requires attention to the return-to-patient experience. Mapping the journey often reveals that a 75-year-old with arthritis cannot easily repack a complex shipper. Tracking days of supply on hand serves as a leading indicator of patient anxiety and potential dropout.

Integration of clinical supply leads into protocol design is essential. Determining what happens when a courier is delayed is a trial design question, not a logistics afterthought. By observing patterns across multiple trials, sponsors can create pooled inventory as a virtual buffer that protects patients without inflating the balance sheet.

Resilience in clinical supply is usually framed as redundancy, with more stock, more layers, more overage. Observation shows a different reality: removing buffers does not eliminate variability, it relocates it. Stress manifests as urgent resupply calls to coordinators, patients tracking shipments anxiously, and tighter reconciliation windows when temperature data flags late.

The savings are visible on the balance sheet. The redistributed pressure is not.

Prior to trial launch, sponsors can define what level of variability patients can tolerate without increasing anxiety or non-adherence. Determining in advance what constitutes a disruption that triggers contingency shipments reduces improvisation during active delays.

Zero waste does not require eliminating buffers everywhere. Targeted buffering at regional depots or across pooled protocols using the same formulation can preserve efficiency while protecting against predictable volatility. Placement, not excess vs. lean, is the operational question.

Environmental stewardship matters. But when reuse programs introduce complex reverse logistics, operational burden should be weighed alongside carbon metrics. Lower destruction rates and lower carrying costs are meaningful, but so are stable retention rates and fewer protocol deviations.

Ultimately, someone at the leadership table must determine where strain is acceptable and where it is not. Lean models are viable, but they require explicit recognition of where new stress points emerge and who bears them when they do.

The Bottom Line

The zero-waste imperative is here. Sponsors can treat it as a pure logistics exercise and watch retention erode, or they can lead within it by protecting the human reality of medication management. True leadership in 2026 starts with being honest about what zero waste actually costs and who bears that cost when the chain breaks.

References:

1. U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE). Medicare Drug Price Negotiation Program: Price Change Over Time Brief. August 15, 2024.
2. Meticulous Research. Clinical Trial Supplies Market: Global Forecast to 2031. 2024.
3. ASPE (HHS). Medicare Drug Price Negotiation Program: Initial Maximum Fair Price Outcomes. 2024.
4. American Trucking Associations. Trucking Industry Forecast: 2025 in Review. 2026.
5. Florence Healthcare. Top FDA BIMO Inspection Findings for Clinical Trial Sites. 2023.
6. Tufts Center for the Study of Drug Development (CSDD). Patient Burden, Logistics Complexity, and Clinical Trial Retention. 2022–2024.

About The Author:

Elisha Lowe, RN, BSN, MBA, is founding principal of IRL Life Sciences Partners building Patient Meets Science, a platform connecting chronically ill patients with life sciences leaders to bridge patient experience and commercial strategy. She brings 17+ years of experience in life sciences commercial and medical affairs across rare diseases, diagnostics, specialty pharmacy, and patient access programs. Her clinical background as a registered nurse in ICU and rare disease settings, combined with hands-on experience in patient logistics programs and medical device training, gives her a unique lens on how operational decisions in clinical supply management directly impact both patient experience and trial outcomes.