Digital Tools Are Failing Patients: 3 Ways Clinical Supply Can Protect Data Integrity
By Elisha Lowe, RN, BSN, MBA, IRL Life Science Partners
In my previous column, I discussed the physical logistics of decentralized trials: getting investigational products safely to patients' homes across different climates, delivery windows, and living situations. We focused on what happens when the cold chain breaks.
But there's a second, equally critical failure point in 2026: when the digital connection breaks. As an industry, we've become experts at getting the box to the porch and building cloud infrastructure to receive data. Yet we're failing at the most critical juncture, which is the distance between the device on the patient's kitchen table and the data reaching the sponsor.
This is the human side of the digital last mile. It's not a software problem. It's a clinical supply failure.
In clinical research, we often mistake technical sophistication for operational readiness. Even the most advanced digital tool is only as effective as the patient's ability to use it. Clinical supply logistics (CSL) teams are increasingly tasked with shipping tablets, wearables, and sensors alongside medication. We must realize that digital connectivity is not just an IT problem. It is a supply chain responsibility.
The Data Reality Check
The industry's push toward digital is staggering. According to the ACRO 2025 RBQM Landscape Report, 96% of clinical trials now include at least one risk-based quality management component.1 Remote risk monitoring has become the industry standard. This makes the digital last mile the single point of failure for the entire monitoring strategy.
A 2025 scoping review published in PLOS Digital Health highlighted the fragility of this connection. In one study, 60% of participants never even installed the required trial app. Even more striking: in another trial, device engagement dropped to just 35% by day five.2 From a clinical supply perspective, when a patient cannot connect their device, we are experiencing a digital excursion. This is a failure just as critical as a temperature excursion for a biologic. Missing data is a protocol deviation that can invalidate the entire trial.
Regulators are no longer giving us a pass on technical glitches. Former FDA attorney Claire Davies recently emphasized that maintaining data integrity in a decentralized environment requires getting the fundamentals right. Specifically: confirming that the target population can comfortably use the technology and ensuring that technical support is available when needed.3 To resolve this disconnect, CSL leaders must adopt three human-centric strategies for the digital last mile.
Strategy 1: Audit For Digital Poverty And Cognitive Load
We often assume every participant has high-speed Wi-Fi and high technical literacy. Reality tells a different story. Many patients, especially in rare disease or elderly populations, face digital poverty. As a nurse and a patient, I know that a person's cognitive load is often already maxed out by their diagnosis. When a kit requires complex Bluetooth pairing, we are adding a tech burden to a disease burden.
The Actionable Tip: CSL teams should include a digital readiness assessment as part of the initial kit design. Think of this as analogous to the site surveys CSL teams conduct for refrigerator capacity before shipping temperature-sensitive drugs. Companies like ICON offer human factors engineering services that evaluate whether specific patient populations have the physical abilities, cognitive abilities, and technological literacy needed to successfully use digital health technologies in their homes.4 This includes assessing potential barriers: dexterity issues, cognitive impairments, and baseline comfort with technology.
If a patient lacks stable connectivity, the supply chain should automatically pivot to a cellular-enabled hub that requires zero setup. Companies like KORE Wireless provide managed IoT connectivity services specifically for clinical trials, including pre-provisioned hubs that eliminate the need for patients to manage Wi-Fi passwords or Bluetooth pairing.5 Don't just send a manual. Send a pictogram quick-start guide glued to the inside of the box lid, so it is the first thing they see.
Strategy 2: Solve For Box Fatigue Through Unified Provisioning
Phase 3 trials now routinely require three to five different digital devices per patient. From the patient's perspective, this is box fatigue. My nursing background tells me that a cluttered bedside leads to errors. If a patient has five different chargers and three different apps to manage, they will eventually prioritize one and neglect the others. The result? Fragmented data.
While a ClinOps lead might select the devices, the CSL team is responsible for the physical assembly of the kit. If CSL doesn't speak up and say, "This kit is too complex to pack and ship reliably," they are the ones who must manage the return/replace logistics when a patient gets confused. We must take upstream ownership to prevent downstream waste.
The Actionable Tip: Demand unified provisioning. CSL teams should push back on protocol designs that require multiple unintegrated devices and insist on consolidated kitting strategies. Where possible, work with clinical operations to select device ecosystems that can share data through a single connectivity hub. This reduces the number of separate interfaces a patient must manage.
I realize this is a significant operational lift. The cost of pre-pairing devices at the depot may seem high, but it pales in comparison to the cost of a return/replace cycle when a digital connection fails. Major players in specialty kitting for direct-to-patient services are beginning to explore advanced configuration capabilities for digital health technologies, though this remains an emerging practice rather than an industry standard. It is hard to implement. But it is becoming the gold standard for preventing patient dropout.
Strategy 3: Implement Clinical Hyper-Care
When a smart-shipper won't open or a sensor won't sync, a patient's first instinct isn't just annoyance. It's anxiety. They worry they have ruined their chance of treatment.
Currently, tech support is often treated as a peripheral service and is rarely integrated with logistics. If a device fails, the patient calls a tech vendor; if a shipment is late, they call the site. These systems rarely speak to each other. We need to move away from generic "I'll fix your password" support toward clinical hyper-care. This is tech support with a bedside manner.
The Actionable Tip: Move digital support under the umbrella of CSL and patient advocacy. We need unified dashboards where a coordinator can see both the shipment status and the device connectivity status. The person answering the phone should understand the clinical protocol and the patient's specific journey, providing a seamless human connection when the digital one fails.
The Bottom Line: Connectivity Is A Clinical Requirement
In the Inflation Reduction Act era of drug development, we are moving toward smaller, higher-value patient populations. Every single data point is precious. In a 20-patient rare disease trial, a single delivery failure is a 5% loss. That patient may be irreplaceable. We cannot afford to lose digital engagement because of a pairing error.
The digital last mile is not a software challenge; it is a human one. By simplifying the tech-stack, auditing for digital literacy, and humanizing support, CSL leaders can ensure that the innovation we ship actually reaches the science we are trying to prove. To unify the patient experience with technical execution, we must treat a broken connection with the same urgency as a broken cold chain.
References:
- Association of Clinical Research Organizations (ACRO). RBQM Landscape Report 2025. Available at: https://www.acrohealth.org/
- Koller C, Blanchard M, Hügle T. Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS Digital Health. 2025;4(6):e0000905. doi:10.1371/journal.pdig.0000905
- Davies C. How To Meet FDA Expectations For Hybrid And Decentralized Trial Oversight. Clinical Leader. January 5, 2026. Available at: https://www.clinicalleader.com/doc/how-to-meet-fda-expectations-for-hybrid-and-decentralized-trial-oversight-0001
- ICON plc. Digital Health: Why Evaluating Human Factors is Essential. September 27, 2024. Available at: https://www.iconplc.com/insights/blog/2024/09/27/digital-health-why-evaluating-human-factors-essential
- KORE Wireless. IoT Solutions for Life Sciences. Available at: https://www.korewireless.com/solutions/life-sciences
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.