OK, no one at the Outsourcing in Clinical Trials New England 2021 conference we attended November 9-10, 2021 actually discussed clinical trial supply and sample management challenges specifically. We at Slope are pretty used to that, but Slope’s ground-level view of clinical trial operations lets us see the unseen and often unacknowledged logistical supply and sample tracking problems affecting clinical trials.
There were three hidden supply and sample management-related stories we came across at OCT, and together they show how not addressing these clinical trials supply and sample management challenges can contribute to unnecessary inefficiencies and costs that can impair patient retention and delay or even derail clinical trials.
Decentralized Clinical Trials (DCTs) have promise, and interest in them increased significantly during COVID. A number of companies have sprung up to manage them, and many of these attended and presented at OCT New England. But people are significantly underestimating the project and supply and sample management challenges of handling trials at a much larger number and variety of locations, including research sites, hospitals, and homes, all differing in what resources they have on hand and in the availability of trained staff. That’s no surprise to us: the supply chain challenges of centralized clinical trials are already underestimated.
The clinical community hopes that DCTs will reduce burdens on clinical trial participants when they don’t have to travel hours to a clinical trial site, and so improve recruitment and retention. But for this to be the case, all supplies have to be available when they are needed to take valid samples, which then must be treated properly and tracked to their final destination.
These procedural problems will be further complicated by the fact that sites are already stretched thin to comply with internal SOPs, sponsor SOPs, and other regulations. Managing multiple locations will be a challenge for Principal Investigators (PIs) and study coordinators, who are usually responsible for managing both clinical trial patients and other patients as well.
When a traveling nurse or other clinician arrives at a patient’s home, they need to have picked up the lab kits appropriate for that visit, use the lab kit meant for that patient, take the sample according to the protocol, manage the samples as they travel from patient to patient, and then ensure that those samples are sent to the appropriate labs in the proper packaging. Managing lab kits and samples at clinical research sites is already a challenge. Adding travel and remote sample collection to the mix increases the clinical trial supply and sample management challenges significantly. Getting to a patient and discovering that the necessary lab kit is expired means missing a sample at that visit. That missing data can cause multiple protocol deviations.
We had interesting talks with a number of these DCT-related companies at OCT New England. One pleasure of presenting a solution to a problem people haven’t adequately appreciated is that look of realization when they begin to understand what has been holding them back. Running a DCT increases supply management difficulties, and requires serious planning far in advance.
An under-appreciated facet of patient-centricity is actually treating patients like they matter. This is particularly true of participants in Phase 1 clinical trials, who have agreed to participate despite the fact that there may not be any therapeutic benefit for them. Having the right kit available for that visit and then getting that sample to the right lab without incident is a seemingly simple problem that turns out to take large amounts of effort and skill to solve, but has a deep impact on patient engagement and retention.
Behtash Bahador of the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP) discussed the concept of Return on Engagement (ROE). If patients feel unappreciated, have to wait without explanation, and then never find out what was learned in the clinical trial they participated in, patient engagement is lower, and, as a consequence, so is retention. Retention becomes a more and more significant issue as a clinical trial proceeds.
An important if underappreciated way of reducing negative experiences and improving patient confidence in medical staff and experimental procedures is to be ready for them when they arrive. When the clinical trial supply and sample management challenges are properly addressed, there is no searching for the appropriate kit, no delays because the investigational product (IP) is unavailable, and a staff that is less harried and better prepared.
And anyone taking the sample knows they have the right lab kit for that particular trial, that particular patient, and that particular visit. Nothing is worse than having to turn a willing clinical trial participant away—especially one who is gravely ill—because the site does not have the appropriate kit in its supply closet. Such a mistake not only affects the clinical results of the trial, it is disrespectful to the trial participant, and can result in their dropping out of the trial. Seventy-seven percent of clinical trial sites surveyed have experienced inventory outages that negatively affected their patients.
Trials already have trouble recruiting and retaining participants among marginalized groups who have reason to be less trustful of the healthcare system. Their presence in trials increases the robustness and applicability of the eventual conclusions. When recruiting for clinical trials, every patient counts, and the cost to the trial of having one drop out is significant.
The best-attended presentation at the conference was probably the one providing sponsors with guidance on how to work through issues with their contract research organization (CRO). The main stress was on communication. Several versions of the question “what do you do when things fall apart?” got the same answer: there is no way you should have let it get to that point. The warning signs from clinical trial supply and sample management challenges would have been visible for six months before. A smoothly functioning supply and sample management system removes friction from research site operations and automatically provides full documentation of each sample throughout its journey from patient through lab to eventual long-term storage in a biorepository. This makes information transfer and reporting significantly easier.
The two presenters, Dr. Angela Johnson of Roivant Sciences and Judy Zahora of Agenus, stressed repeatedly the fundamental importance of explicitly laying out how issues are communicated, to whom, and under what circumstances. Constant data collection and analysis will show trends early. Everything must be documented at all times—and we certainly know how challenging that is to do without the help of automated systems.
An issue that always needs to be kept in mind is staff turnover. The Clinical Research Associates (CRAs) who monitor the clinical sites have particularly high turnover rates. This increases the importance of good documentation since the likelihood is that the staff at the end of a clinical trial will not be the staff that started it.
We did talk a lot with people about clinical supply and sample tracking, clinical inventory management, and clinical trial logistics. People are increasingly realizing that failure to get a grip on these clinical trial supply and sample management challenges leads to friction, stress, and errors that affect both staff and patients, as well as the eventual results of the clinical trial itself.
By tracking and managing every sample, Slope enables DCT providers to ensure that the clinicians arrive at each patient visit with the appropriate lab kit, the right samples are collected, and they get to the right lab at the right time, despite the vastly increased complexity of modern clinical trials.
By ensuring that the appropriate lab kit is available when the patient arrives to have their sample taken, we help the clinical trial site maintain engagement with the trial participating patients by treating them with respect.
And by reducing friction and error while automatically generating the data that tracks every sample, we help sites, CROs, and sponsors keep the clinical trial on track, even as staff changes. So the clinical trial supply and sample management challenges are no more.
Slope will be at Outsourcing Clinical Trials Southern California December 7th and 8th. Come visit us at booth #49 and enter to win an Apple Watch Series 7.
Connect with our solutions experts to learn how Slope can address your clinical trial supply and sample management challenges.