Clinical Supply's Role In Driving Success In Decentralized Trials
By Elisha Lowe, RN, BSN, MBA, IRL Life Sciences Partners
Decentralized trials (DCTs) are no longer theoretical. Sponsors are moving forward whether supply chains are ready or not. Clinical Supply Logistics (CSL) teams must plan for variable delivery windows, patient home storage challenges, and temperature-sensitive shipments from the onset.
When you place investigational product directly into patients' homes across different geographies, seasons, and living situations, you've fundamentally changed what clinical supply operations must accomplish. The new question becomes whether your team can execute DCTs reliably at scale.
Why CSL Matters To The Enrollment And Retention Crisis
The clinical trial industry faces a recruitment and retention crisis that threatens the entire drug development pipeline. Nearly 80% of clinical trials fail to meet enrollment targets on time, and 85% struggle to retain enough patients to reach valid conclusions.
According to recent analysis from the Tufts Center for the Study of Drug Development, each day of delay costs sponsors approximately $500,000 in lost prescription drug or biologic sales and $40,000 in direct daily clinical trial costs.1
Patient dropouts consume a significant portion of trial budgets. When patients drop out, they don't drop out because of the investigational product. They drop out because the experience of participating was too difficult.
For many patients, especially those with chronic or rare diseases, the burden is logistical:
- Travel to site visits
- Time away from work or family
- Storage challenges at home
These burdens highlight where CSL teams can intervene: optimized shipping, clear labeling, and reliable direct-to-patient (DtP) delivery.
The Hybrid Model Demands Operational Precision
Patient preference drives decentralization. Research shows:
- 44% of study participants report traveling to a study clinic is burdensome.2
- 57% prefer participating mostly from home with only a few site visits.3
With so many patients preferring at-home participation, CSL teams must manage dual delivery pathways: bulk site shipments and DtP home shipments for the same patient at different trial phases.
The Logistical Pivot: Where CSL Drives Trial Success
This is where your expertise becomes central, not peripheral. The shift to DCTs is not a replacement for CSL expertise. It's an amplification of specialized skills.
The logistics strategy is now a direct extension of patient experience. You're moving from large, predictable bulk shipments to highly personalized DtP deliveries that must reach the patient's home with pharmaceutical-grade integrity intact.
The operational complexity multiplies across five key areas.
The Operational Complexity Shift
What CSL Teams Must Do Operationally
Start with geography. A patient in Phoenix in August doesn't face the same storage challenges as a patient in rural Alaska in January. Yet most thermal packaging protocols treat all home environments as equivalent. Your packaging engineer should be mapping patient locations by climate zone and adjusting specifications regionally. This isn't theoretical best practice. Cold chain failure at a doorstep is a protocol deviation that invalidates data.
During site selection conversations, work with coordinators to identify high-risk delivery zones before enrollment begins. In rare disease trials with 20 to 50 patients, a single delivery failure represents 2%-5% of enrollment loss. That patient may be irreplaceable.
Then rethink labeling. You can engineer the most sophisticated temperature-controlled shipper possible, but if the patient doesn't understand "Remove from shipper within 2 hours," the entire cold chain fails at the doorstep. Design instructions that account for patient literacy, visual acuity, and cognitive load in home environments where site staff aren't available to call.
Research on patient medication labeling demonstrates the importance of this approach. A comprehensive study tested patient package inserts with focus groups and comprehension testing, including participants with varying health literacy levels.4
Testing revealed that structured comprehension testing with a predefined target of 25% limited-literacy participants — using validated assessment tools like the Newest Vital Sign — identified significant clarity gaps. This evidence-based approach resulted in 96% comprehension among all populations tested, with 90% comprehension achieved even among participants with limited health literacy.
Include visual cues: color-coded temperature strips, pictograms, timer instructions. Recognize that patients with chronic disease often manage multiple medications. Your investigational product labeling needs to visually distinguish itself in a home medicine cabinet.
Labeling isn't administrative overhead. It's your patient safety mechanism in an uncontrolled environment.
Rethink delivery windows next. Traditional site models work around clinic hours. DtP models must work around patient life. Standard couriers offer 8 a.m. to 5 p.m. windows, which doesn't work for employed patients.
Forward-thinking CSL teams should negotiate evening or Saturday delivery options with carriers. It costs more but directly impacts adherence.
Build predictable delivery schedules into the protocol itself. A patient who knows medication arrives on the third Tuesday of each month can plan around it, reducing complexity and improving adherence.
When protocols incorporate wearables and remote monitoring devices, understand that you're no longer just shipping medication. You're coordinating delivery, setup, training, troubleshooting, and replacement of the devices generating trial data.
More than 130 pharmaceutical and biotechnology organizations capture clinical trial endpoints using connected, sensor-based digital health technologies that use AI/ML to process and analyze data, and this adoption trend is accelerating.5
Work with digital health vendors during trial design to build device replacement protocols into your supply chain workflow. Train your DtP logistics coordinators to troubleshoot basic device setup issues over the phone. Without proper setup support, patients are unlikely to use complex devices effectively, generating protocol deviations and missing data.
In technology-enabled trials, CSL teams are often the patient's first point of technical support.
Additionally, understand how rare disease changes the supply chain math. The Inflation Reduction Act has created strong incentives for sponsors to focus on small patient populations.6 In a 500-patient cardiovascular trial, a single delivery failure is a 0.2% setback. In a 20-patient rare disease trial, it's a 5% loss. And the patient may be irreplaceable.
This requires different contingency planning. Build higher safety stock into geographically distributed networks. The cost of excess inventory is lower than the risk of a failed delivery when patient numbers are this small. Develop rapid-ship backup protocols so replacement products can deploy within 24 to 48 hours if a shipment is compromised.
Create patient-specific inventory tracking. You should know not just how many doses exist, but exactly which patients have received doses, when their next shipment is due, and what backup capacity you have if a dose is lost.
The Moment For CSL Leadership
The clinical trial industry is accelerating toward decentralization. Sponsors designing rare disease and orphan drug trials are under financial pressure. They need partners who understand both the logistical complexity and the strategic urgency — not just the logistics but the patient reality that drives everything.
CSL professionals who understand these operational realities are positioned differently in sponsor conversations. You're not a logistics vendor. You're the partner who connects patient realities to supply chain realities to trial outcomes.
The question isn't whether your team will support DCTs. The question is whether your team will lead them operationally. That is where CSL drives trial success.
References
- Tufts Center for the Study of Drug Development (CSDD). "New Estimates on the Cost of a Delay Day in Drug Development." October 2023. PubMed. https://pubmed.ncbi.nlm.nih.gov/38773058/
- Center for Information and Study on Clinical Research Participation (CISCRP). "2021 Perceptions & Insights Study." November 2021.
- James Lind Care. "The Patients' Perspective on Decentralized Trials." https://jameslindcare.com/decentralized-clinical-trials-patient-recruitment/
- Jacobson KJ, Forney F, Margolis MR, et al. "An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling." Therapeutic Innovation & Regulatory Science. August 2021;55(4):755-765. https://pubmed.ncbi.nlm.nih.gov/34341945/
- ICON plc / HumanFirst. "Digital Endpoints Widely Adopted in Pharmaceutical and Biotech-Sponsored Clinical Trials." August 2024. Analysis derived from ClinicalTrials.gov data (2008-2022).
- Information Technology and Innovation Foundation (ITIF). "The Inflation Reduction Act Is Negotiating the United States Out of Drug Innovation." February 2025.
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.