Nico Hoeler, Managing Director, TEC4MED LifeScience GmbH, explores the advances being made in home-based clinical trials and direct-to-patient deliveries
Home-Based Clinical Trials (HBCT) are the future of clinical trials. According to the CEO of Marken, Whes Wheeler, at least 10 percent of all clinical trials will take place at the patient’s home within the next two to three years. The greatest growth is expected in the areas of all cancer-related drugs, cell and gene-therapies, immunotherapies, and of course all biologicals and biosimilars.
Enabling HBCT increases the trial’s acquisition, compliance and retention rates, offering more choices on site and thus patient selection. As a result, HBCT facilitate a much faster overall conduction – risk of failure is minimized, study budgets are unburdened and the overall success is increased.
Transforming the industry towards a patient-centric approach, cold chain logistics will be more personalized and fragmented, requiring special and complex treatment. Therefore, the cold chain logistics behind the HBCT will be confronted with the following challenges:
- Low shipping volumes of high, sometimes even invaluable, monetary value
- Fragmented and thus unpredictable shipping process
- Reverse logistics, since not only the direct-to-patient Delivery (DtP), but also the direct-from-patient delivery (DfP) of samples requires professional care
- Involvement of many different parties: Mobile study nurses, doctors, pharmacists, third party logistics providers and patients
- End-to-end GxP compliance
- High time and cost pressure of a clinical trial
These challenges transform into a last mile logistics process that is often very complex and costly. Its expenses are mainly driven by the inevitable and correct implementation of the following aspects:
- Intensive training of non-cold chain specialists (such as mobile study nurses, doctors or even patients)
- Involvement of specialty logistics providers to master the delivery process with a strict observance of time frames
- High precision in scheduling, due to very limited time frames
- Manual and error-prone monitoring solutions, trying to match the full end-to-end visibility of the cold chain and logistics process
A Tailored End-to-End Process
The reason for such strict adherence to these aspects is the lack of an end-to-end cooling solution. As of today, the whole process is projected by various cooling devices, such as a passive shipping container for delivery, and an active medical fridge for storage at the patient’s home. Data are usually stored and processed offline and online, using integrated or external temperature loggers. These must be handled in person and cause many disruptions alongside the monitoring and protocol process.
Last but not least, many non-cold chain specialists, such as doctors, mobile nurses and patients are involved in the process – all with access to the Investigational Medicinal Product (IMP). To minimize the risk of the latter negatively affecting the cold chain and sabotaging strict timelines, intensive training, and the inclusion of professional but expensive specialty pharma logistics providers becomes essential.
All of these aspects, however, could be prevented by using a tailored end-to-end cooling solution. Introducing active parcel cooling and the Internet-of-Things (IoT) to HBCT could tremendously improve the process:
- No preconditioning of ice packs (incl. summer and winter packaging orders)
- No packaging errors (e.g. icepacks touching the IMP)
- No warehouse infrastructure
- Flexible and independent cooling at the push of a button
- Monitoring of temperature, humidity, shock, access and geo-location
- Fully automated Live Tracking, no required user interaction (No-UX)
- Automated protocol with browser access and APIs
- No false alerts, full end-to-end visibility
- Active and electronically controlled cooling between 2-8°C or 15-25°C
- Runtime of up to 24 hours
- Prolong runtime either by swapping the batteries or by recharging the device at various voltages and electrical plugs
- Personalized access
Active Cooling Systems
In addition, all of these advantages do not just apply to mobile use cases. Active cooling works perfectly in stationary use as well. Once the medication is delivered to the patient or picked up by them at the trial center or pharmacy, the active parcel shipping container can be used as a stationary refrigerator. That way, even larger amounts of medication can be safely stored and monitored at the patient’s home, minimizing the frequency of deliveries, interactions and potential failures. Futhermore, highly sensitive IMPs are not changing the cooling device, giving full end-to-end control and compliance back to the process.
Besides being the physically safest cooling solution for last mile delivery, all integrated IoT tracking functions offer various other advantages that come along with big data. First, none of the data are confronted with media disruptions: All information can be automatically stored and processed online and is safely provided to those in charge, no human interaction needed. Second, all data can be analyzed in direct correlation to their cause: e.g. a potential change of temperature due to an opened door. Third, all the collected data can be automatically analyzed and evaluated as follows:
- Temperature risk-profiles of different lanes can be processed, predictive maintenance applied
- Adherence of the patient monitored
- Reorders of deteriorated drugs automatically processed
- Timetables and logistics processes are analyzed in CAPA (Corrective and Preventive Action) before eventually optimized
In summary, smart active parcel cooling can minimize the risk of human misconduct and thus the risk of cold chain failure, since the technology itself and all data behind take care of it. It relieves all unnecessarily involved people in the cold chain process so they can refocus on their actual core business. Active cooling in last mile logistics offers various opportunities to minimize costs through process optimization, not only in medication safety, but also in terms of faster and less complex processing structures.
Consequently, active parcel cooling is giving full end-to-end visibility to third party logistics providers, specialty nursing organizations, CROs, and of course the sponsor. This unburdens study budgets and ultimately increases patient safety. In contrast to all passive cooling solutions, active cooling technologies make safe, cost-effective and GxP-conform HBCTs and homecare programs possible.