Join the dots between providers to untether DCT potential
Decentralised clinical trials can drive efficiency and patient centricity, but only if the sector learns to join the dots between stakeholders.
Hybrid and decentralised clinical trials (DCTs) are fast becoming the norm. Yet, the complex network of providers and partners needed to bring them to fruition can sometimes create a logistical nightmare that erodes, rather than enhances, efficiency.
Mobile health providers and central laboratories, for example, are often unaware of each other’s needs. This can lead to delays in study set up and initiation, and create needless operational barriers throughout the trial.
That’s why Tom Brazier, director of decentralised clinical solutions at mdgroup, and Stephanie Larimer, decentralised trials solutions manager at Q² Solutions, believe that an eco-system approach, driven by early and meaningful cross-vendor collaboration, is key.
A new era
Hybrid and DCTs are fast becoming the norm, and the change shows no sign of slowing. The market, worth an estimated $8.8 billion in 2021, is expected to increase by 10% year on year, and reach $14.2 billion by 2026.
It is easy to see why. The model, which replaces at least a portion of clinic visits with remote appointments, can streamline research, enhance patient centricity, and increase inclusivity and cohort diversity.
Implementation, however, is not without its challenges. Sponsors not only need to adopt a new suite of technologies and solutions, they also need to learn how to seamlessly integrate their providers into the existing research infrastructure. In short, the shift represents a significant shift in the way we “do” research, says Brazier.
“Decentralised solutions themselves are a tool. If we want to embed them into clinical trial protocols efficiently, we need the right processes and procedures in place to ensure we get the right solutions for the right study,” he says.
“Having time at the beginning of a study where we can understand each other’s requirements and how we can bring them together is really helpful. There is a lot we can find out from reviewing a lab manual and a protocol, but there is a lot more that we can’t.”
These studies tend to be conducted using a patchwork of different service providers and vendors, including the mobile health providers who collect the clinical samples and the central laboratories who analyse them. While these two key stakeholders are dependent on each other to do their job, often there is no direct line of communication between them.
“At the moment, the sponsor tends to become the key contact for both the mobile health provider and the central laboratory, and attempts to pass messages between the two,” says Larimer, adding not only does this place additional burden on the sponsor team, but also it is not the most effective or efficient way to communicate trial needs.
DCTs are often lauded as a way to streamline lengthy research processes, helping drug developers to get the medicines they create to the people who need them as quickly as possible. Yet, the communication blackout serves to add, rather than remove, barriers to efficiency. It can delay set up and initiation and result in replicated efforts – problems that could all be avoided with early cross-vendor collaboration.
Says Brazier: “Having time at the beginning of a study where we can fully understand each other’s requirements and how we can bring them together is extremely helpful. From a mobile health point of view, there is a lot we can learn from reviewing the lab manual and protocol, but there is a lot more that we can’t.”
Larimer agrees, citing first-hand central laboratory experience of how the “broken telephone effect” can result in unnecessary barriers and delays.
“We can be awarded a study, but not even know there is a remote element until we are asked to send kits to a depot,” she says. “There are some aspects of sample collection that just can’t be done at home, or at least will need to be modified.”
It can be equally disruptive from the other side, Brazier explains. “As a mobile health provider, we need to know that the protocol, the lab manual, and the samples being requested are suitable for the home setting. In the past, we have had studies where samples have required chemical additives, complicated centrifuge steps, or immediate storage in dry ice, for example.”
Such disconnects will often necessitate lengthy discussion and amendments, “all of which takes time”, Larimer added. “In our industry, everything is needed yesterday. Having to update the lab manual just before the study starts is far from ideal.”
Once the study is underway, neither party knows what they don’t know. Mobile health providers, for instance, may not be aware of the contents of central laboratory sample collection kits, and when something is missing.
This can prevent visits from taking place or samples from being collected, leading to avoidable repeat visits, missed data points and, ultimately, increased costs.
Fixing the broken telephone
Simply putting the two providers in contact as soon as possible, Brazier and Larimer argue, could save a lot of time, money, and headaches.
“We in the central lab are the experts on collecting the samples and how they need to be processed,” Larimer says. “We will be better able to advise on things like alternatives to refrigerated centrifugation and validated standard lab processes than the sponsor.”
Early collaboration would also allow laboratory manuals and mobile health staff training materials to be developed in parallel, rather than in the current stepwise approach. This would not only save time – and therefore money – overall, but it would also make sure these crucial documents are compatible.
Says Brazier: “At the moment, there is limited to no collaboration between companies like mdgroup, who are sourcing healthcare professionals and training them on the lab requirements, and companies like Q² Solutions, who are creating those lab requirements. There is a real opportunity to streamline and improve the quality of things like training materials and training sessions.”
Sample queries is another area of interest, says Larimer. “Laboratories tend to send all their queries to the sites. They forward them on to the mobile health vendors, who contact their workers in the field to resolve the query. It takes time.”
If central laboratory staff were able to direct relevant queries to the organisation or healthcare professionals responsible for the remote visits, the whole process would be much more efficient.
If we are to truly embrace the power of decentralised research, we have to learn to navigate the potential pitfalls, including the disconnect between providers.
Early and meaningful collaboration between the laboratory and the mobile health company is crucial for more aligned, more efficient trial planning and execution.
About the authors
Tom Brazier, director of decentralised clinical solutions, mdgroup
With experience in global project management and global team management across central labs and patient support services, Brazier brings extensive leadership experience to mdgroup’s Decentralised Clinical Solutions department. In his role, Brazier aims to improve the availability and accessibility of decentralised solutions and increase awareness of how and when they should be used to get the biggest benefit. After graduating from the University of Exeter with a BSc in Biochemistry, Brazier then went on to work for Q2 Solutions (central lab) before taking a role at mdgroup to get one step closer to patient care.
Stephanie Larimer, decentralized trials solutions manager, Q2 Solutions
After a brief tenure as a high school biology teacher, Stephanie Larimer transitioned into the clinical trial laboratory space at Q² Solutions and has since established herself as a global project services professional across central labs. In her current role, Larimer’s mission is to implement novel solutions that improve the efficiency and effectiveness of remote collection operations. In addition to receiving a master’s degree in biology from West Chester University of Pennsylvania, she has earned the ETS Recognition of Excellence Award for biology content knowledge.