The Undervalued Importance of Last Mile Logistics in a Clinical Trial

On average, sponsor companies invest between $1 billion and $3 billion in ushering a new drug to market. As they progress to the final and pivotal trial before submission to regulatory authorities, the stakes heighten, approval looms closer, and undoubtedly, logistical intricacies multiply. During this phase, planning typically revolves around recruitment challenges and local approvals, but an often overlooked yet significant hurdle emerges: the so-called “last mile”.

In the past, the last mile primarily focused on ensuring the successful delivery of IP to sites. However, in today’s decentralized clinical trials (DCT) landscape that increasingly includes provisioned devices (phones and tablets), wearable sensors, and electronic Clinical Outcome Assessments (eCOA).

The final mile now hinges on the flawless deployment of a myriad of devices, sensors and associated materials. Timely delivery of properly functioning equipment, ensuring user comprehension of how to operate the systems and equipment coupled with an on-site management strategy becomes pivotal for the success of the study. This spans across recruitment, retention, adherence to the protocol, and, ultimately, the ability to capture clinical research data

If you are an investigative site, the last mile described above is your first mile. While much of the schedule of visits will depend on equipment you already have, the work and planning to get IP and logistics to your site is really what allows you to enroll your first patient.

However, additional devices, whether they are used to collect consent or clinical measurements, assess patient satisfaction, track daily drug usage, etc, can come from an ever-evolving number of providers and often must also be on hand before a patient can be enrolled. How can you, the site community, cope with this challenge?

The challenges of technology that the site faces are multifaceted: a single study will utilize 8 or more different applications or portals. The site staff must train on each of these, in addition to the 4 systems that many sites already use for their standard workflow such as eSource, eReg, CTMS, email, and patient payment portals.

Technology usage aside, logistics such as planning and accounting for the wearables and devices is an overlooked and sometimes overwhelming requirement for study teams. For example, when Rochester Clinical Research (RCR) receives a shipment of devices, often there are NO identifiers as to the protocol, sponsor even the PI on what the devices are intended to be used for. A guessing game ensues.

Sites need to find a secure location that has numerous power outlets available for charging. Being advised to monitor the device so they are not left charging is simply not a feasible option for sites. There is often “rationing” with just-in-time delivery of the devices and lengthy delays in re-supplying the devices at high-enrolling sites. The alternative of having participants use their own devices solely for the trial can create additional challenges of data plans, wifi availability, etc.

As you contemplate a study that likely or definitely will include devices and wearables, here is a set of suggestions on items to consider or plan for to support a successful study.

1. An Ounce of Prevention

Planning for the use of devices and sensors should start in advance of the study. The use of devices and sensors will have an impact on your budget as well as other considerations during the trial. If possible, ask for a list including the quantity of devices and sensors that will be shipped to the site.

Other things to consider include:

• Will they be shipped just in time or in bulk (which will require storage)?
• Will you be expected to retain the packaging until the end of the study (which will require storage) or can you discard it?
• If the study is relying on patient devices to bring their own devices (BYOD), will backups be provisioned (which will require storage)?
• Will devices need to be updated in any way after receipt? On occasion, technical solution providers will deploy an application or web-based updates after the equipment is shipped.
• What are your local IT security standards? Will they allow for these devices to be used with your WiFi?
• What is the cellular data reception like in your location? What about your participants? Do you foresee any challenges with poor service?
• Devices may have to be replaced during the study if the duration is longer than the warranty or useability of the device.

Understanding these items will allow you to consider if storage is available and to put it into your study budget and ensure devices are ready for participant use.

Recognize that provisioned devices may be a different Make/Model/operating system than the participant is familiar with and this may impact their acceptance or interaction with the tasks required of them.

Be prepared to walk the participant through the basics of using said device such as charging, button placement, and how to use basic features. This will help participants get started without experiencing friction later. Concerning BYOD devices, ensure that the technology can be used with their specific model and operating system.

While you are planning, also consider how much you understand about your current patient population or the volunteers in your patient database. Do they have smartphones already? Do they have wifi at home and are their data plans sufficient for trial participation? If they are someone new to technology, do they live with someone who might be able to help them navigate some basic instructions? Knowing this will help you also plan for what time may be required to support the participants. Not all study participants have a smartphone or unlimited data plans.

2. Training

Training is a hot topic right now. SCRS has collected feedback to show some of the increased burden that sites have experienced as a result of new technology. While it is time-consuming, if you can, track the time that the standard training takes per device or log in. Identify if previous training can count towards future use or if each study will require you to repeat essentially the same course. Use this data to plan your budget and provide the information to the sponsor or CRO in advance. You never know when the site experience may inform the study team’s final decision on what technology to use.

3. Adoption

Data from Medable’s Site Adoption team shows a surprising trend. It’s often “getting started” that has caused the most calls to the help desk amounting to approximately 60% of all support tickets. This includes completing training, getting your credentials logging in, and taking the first basic steps in the system. Once a coordinator has gotten exposed to new tech, they are far more comfortable integrating and supporting technology and the inquiries to the help desk dramatically decline.

However, it also happens that devices arrive and they don’t work as promised. Inquire about what support will be provided and how, both before study start and during your site’s participation, knowing that will help you develop a budget but also a resourcing plan for support, while also minimizing the inconvenience and frustration felt by your site staff and participants.

4. Taking Inventory of Your Team

Another way to cope with the challenges that accompany the logistics around integrating tech is to understand who within your organization is best suited to provide support.

At Rochester Clinical Research (RCR), they created a role specifically designed to assist their seasoned coordinator and PI staff through the use of a digital native. This role is aimed at professionals who want to work in research but came of age during the digital era. They are not replacing paper in their workflow because their education or first jobs didn’t require the use of paper.

RCR learned firsthand that the digital native skill set was different than those who were even just a few years older. When faced with technology created quickly during large volume trials in the middle of the pandemic, RCR had to pivot quickly to be able to utilize the patient-facing technology. They created a role for digital natives to assist the study participant with the diary devices, the engagement specialists helped the subjects create an email address, access the app store, set pins, and be on call to troubleshoot since critical data was being lost due to participant challenges with the technology and poor help desk assistance. Essentially, they created their helpdesk to ensure compliance and decrease frustration for both staff and subjects.

Not all sites will be able to do this nor should they have to, but for the participant to be successful, expanding the role and responsibilities of the study team to include this type of support, may be necessary.

5. The Role of Technology Providers

How do you prepare and test devices before deployment? Do you have an option
to use your site’s own devices rather than a study-specific device and can you specify this at SSV?

• Tracking, both for inbound shipments and returns, but also for equipment at site. How is one tablet distinguishable from another? Recommend study-specific labeling to your CRO/sponsor. Devices frequently arrive without any identifiers as to sponsor, protocol, CRO, or even PI.
• Return Logistics: couriers will often not specify a time for collection; how can you work to support the site in terms of planning? Ensure that all importer of record paperwork is completed correctly with cross-border returns.
• Safety and storage of Lithium Ion battery powered devices: never leave indefinitely connected to a charger to avoid the risk of overheating and/or fire.

New technology brings promise and opportunity, but the impact on the site workflow needs to be considered. Let us know what aspects of device and sensor management you all have found to be the most challenging and any suggestions for improvement. Take Medable’s survey on devices and wearables at the site level.

By Carl Franzetti, Technology Operations, Medable

Mary Costello, Site Evidence, Medable

Pat Larrabee, Founder, Rochester Clinical Research