Moving into the Future of Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2021, Volume 30, Issue 7/8

COVID-19 provides unique opportunity for overhaul of logistics.

From Prague to Minneapolis to Dubai, clinical trials are increasingly global—and that makes logistics, now more than ever, a mission-critical factor for conducting a successful clinical trial. However, if there are delays during the clinical trial phase, the financial impact can be staggering.

While any number of factors might cause delays, from strategic challenges to commercial barriers, logistics can play a key role. Every delay, from equipment not arriving at a clinical site on time to patients unable to arrive for an onsite visit, creates an avalanche of effects, from decreased patient retention to increased time
to market.

As with other aspects of clinical trials, the COVID-19 pandemic severely impacted the logistics that fuel the supply chain. By July 2020, almost 200 companies had stopped or delayed their clinical trials because of the pandemic,1 and it’s estimated that about 80% of non-COVID-19 clinical trials were interrupted or stopped.2 As the pandemic continued, with delays continuing for months, trials that were in progress were hampered as any inventory redundancies built into their supply chain eroded.

The pandemic—and the upheaval that came with it—underscored gaps in clinical trial logistics. It also created opportunities for organizations to reimagine the process for creating more efficient, reliable, patient-centric clinical trials.

Bringing clarity to future trials

Before the COVID-19 pandemic, many sponsors and CROs had already begun to leverage digitalization to operate more efficiently and prevent costly downtime. As the need to quickly and safely develop COVID-19 vaccines and treatments emerged, organizations needed visibility into their processes as well as the full supply chain. Sponsors and CROs already using digital solutions were better positioned to make that pivot quickly because they already had real-time transparency to make strategic logistics decisions.

In COVID-19’s wake, sponsors, CROs and their logistics partners will need to continue and even expand visibility into every logistics touch point, ensuring supply chain integrity. Along with making sure shipments meet regulatory guidelines, the “Amazon effect” has also increased visibility expectations. Everyone along the supply chain, including clinical staff and patients, want to know not only where their supplies and equipment are, but precisely when they will arrive.

In addition to the expectation for increased visibility, there’s a growing need for flexibility. Traditionally, sponsors and CROs have relied on recruiting parameters based on numerous factors, from regional patient populations to a disease’s prevalence in the population. Predictions help organizations ensure that they are sending the right kits to the right clinical trial sites. Miscalculations can lead to oversupply at one site and shortages at another.

Digitalization tools can provide the transparency needed to overcome these challenges. For example, a kit with a scannable label can be tracked across the entire supply chain, from the moment it leaves the kit assembly line to the patient’s home and finally to the biorepository. Machine learning tools can take the process a step further by considering various factors, like capacity or hours of service, across multiple supply chains. Radio-frequency identification can also help manage shipments needed to service these clinical trials.

These capabilities provide dynamic, multi-mode estimated time of arrival information, whether a package is delayed at a border crossing or five blocks away from a patient’s home. End-to-end visibility enhances the patient experience but can also create the tracking and traceability needed to meet regulatory demands.

Maintaining regulatory compliance in emerging regions

As the COVID-19 pandemic created the need to fast-track vaccines and treatments, emerging geographies, like the BRICS block (Brazil, Russia, India, China and South Africa) and the Middle East, became important locations for related clinical trials. While their large, diverse populations are ideal for conducting multiple, large-scale trials in parallel, the regulatory process in these nations is still evolving. This creates a challenging regulatory landscape for logistics.

From clinical trial approvals to transporting clinical supplies and medical equipment, regulations can vary greatly from country to country. Regulations for transporting clinical trial products and medical equipment can be inconsistent, making it more difficult to plan and coordinate across jurisdictions, especially if they are governed by different regulatory organizations. For example, different transportation modes within an area might require specific types of paperwork to be secured. In addition, the timelines in emerging markets can run much longer than what might be considered standard when conducting trials in many Western nations. Even in well established markets, regulations change and the supply chain needs to adjust to new regulatory standards, such as EU MDR regulation in Europe that came into effect May 2021.

As clinical trials move forward, CROs and sponsors need to fully understand clinical trial regulations in every jurisdiction in which they operate. Working with local trial coordinators or partners who understand each region’s unique logistics challenges can help organizations understand regulations within all relevant jurisdictions to avoid the inadvertent violations and help trials stay on track.

Managing home delivery

In many aspects, the logistical challenges common to traditional, on-site clinical trials are also evident in those that are hybrid or virtual—albeit on an exponential scale. For example, rather than delivering equipment to a dozen sites for a specific trial, a decentralized trial might require thousands of individual shipments to patients’ homes.

Logistical complexity goes beyond simply making sure the right patient gets the right kit at the right time. Other factors might include coordination and pickup of biological samples from patients, or the return of equipment or perhaps materials that are partially used, unused or even expired. And extending beyond logistical complexities, data compliance regulations, such as HIPAA or GDPR, expand further back in the supply chain as partners need to handle patient data that enables home delivery of equipment as well as labeling for sample collections.

Sponsors and CROs may want to consider partnering with specialized companies with the resources and experience to manage direct-to-patient shipments, no matter where the supplies or equipment is being sent. These types of partnerships can help ensure the sponsors or CROs can focus on clinical trial design and outcomes as well as patient experience.

Leveraging wearable medical devices

Mobile health (mHealth) is one tool helping facilitate clinical trial logistics. Two-way communication medical wearables, like smartphone apps, patches or other monitoring sensors, can measure essential biometric data. In addition to providing clinical staff with accurate, real-time health data, these devices help to reduce or eliminate the need for in-clinic visits, making it easier for trials to continue even in the face of unexpected macro events. Patients also experience a greater degree of independence because the technology reduces or eliminates the need for clinic visits, which helps increase retention. mHealth devices can reduce costs, too, by decreasing the time and expense related to in-clinic visits.

Wearable medical device usage is perhaps one of the most exciting aspects of the clinical trials of the future. mHealth devices are currently in the first generation of development. As developers continue to refine the technology, it will evolve, much like the apps consumers use on smartphones. CROs able to leverage this new technology by acquiring or partnering with software companies can help move innovation forward to improve the trial’s efficiency and the patient’s experience.

Delivering training in a decentralized clinical trial

Logistics is more than the movement of people and products; it’s also about the movement of information. As COVID-19 led to wider adoption of decentralized clinical trials, sponsors and CROs were prompted to find effective ways to deliver the training patients need to participate in their care. In traditional clinical trials, a recruited staff would receive any relevant training at the team level. However, hybrid and virtual trials require the delivery of that information to each individual patient.

For example, clinical teams can transmit alerts to a patients’ wearable or medical device to remind the patient to conduct a test or provide a sample. An app might also deliver information, like instructions, so if the patient doesn’t understand a process, they can view a step-by-step how-to guide or even contact off-site, 24/7 support.

Considering additional challenges

Data and cybersecurity in logistics is a concern that will become more critical in the near-term. In traditional clinical trial site settings, patients’ private information is blinded from supplier, service and logistics partners. For example, a repository sample might be shipped with a patient information rendered as a code.

Now, hybrid and virtual trials require partners to ship directly to or pick up directly from patients, requiring partners to have access to a range of personal information, from the patient’s name and address to the study type to the serial number of the equipment used. Data that is not properly secured can create cybersecurity risks that potentially expose confidential patient information as well as violate regulatory standards.

In addition to data and cybersecurity compliance with GDPR in Europe and HIPAA in the United States, sponsors, CROs and their logistics partners must navigate emerging regions where the intersection of virtual trials, data and cybersecurity is still in the early stages of development.

Moving forward into opportunity

No matter how quickly the clinical trial landscape changes or where those changes lead the industry, there is one factor that will not change: expect the unexpected. There is simply no way to predict every unforeseen event. Within the last few years alone, logistics within the pharmaceutical industry, and clinical trials in particular, have been challenged with events ranging from COVID-19 to Brexit to the vessel that temporarily blocked one of the world’s busiest trade routes, the Suez Canal.

The unexpected will continue to challenge organizations to maximize robust, flexible logistics that ensure supply chain integrity—and those in the clinical trials space will rise to meet that challenge and leverage the opportunity it brings. Whether supplies are being shipped to a patient’s home or equipment is being moved from one clinical site to another, reliable logistics is a key factor in creating an efficient and reliable patient-centric clinical trials.

References

  1. Adams, B. Fierce Biotech. (Online) Available at: https://www.fiercebiotech.com/biotech/more-than-two-thirds-trials-hit-by-covid-enrollment-halts-midstage-tests-worst-affected#:~:text=Drilling%20down%20into%20the%20numbers,impacted%20due%20to%20slow%20enrollment (Accessed 5-24-2021)
  2. Van Dornb, A. COVID-19 and readjusting clinical trials. Available at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31787-6/fulltext (Accessed 5-24-2021)