Tom Brazier, Director, Decentralised Clinical Solutions, mdgroup and Stephanie Larimer, Q² Solutions discuss the opportunities for decentralised clinical trials and how common pitfalls can be avoided through communications and streamlined working.
Hybrid and decentralised clinical trials (DCTs) are fast becoming the norm, but they often involve multiple vendors and service providers, presenting sponsors and CROs with new considerations on the logistics of study conduct.
By leveraging the expertise of their vendors, sponsors and contract research organisations (CROs) can avoid common pitfalls that can contribute to inefficiencies, safety concerns, and increased costs.
The logistics of DCTs
The number of clinical trials being conducted via the DCT and hybrid model has increased significantly in recent years, and the pace of 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, to $14.2 billion, by 20261.
Yet DCTs themselves are a new tool and embedding them into routine workflows relies on having the right processes and procedures in place.
Sponsors and CROs must for example, think about how to streamline the logistics of these studies, which tend to be conducted using a patchwork of different service providers and vendors – including mobile health providers, who collect the clinical samples, and central laboratories, who analyse them.
Despite each of these service providers being dependent on the other to do their job, there is often no direct line of contact between the two. Instead, the shared client becomes the key liaison for both, impairing effective communication, draining clinical trial efficiency, and placing additional burden on the sponsor.
On the ground, this lack of direct communication can create a ‘broken telephone’ mode of operation and means the two providers are unaware of – and therefore unable to account for – each other’s needs and limitations.
Sponsors /CROs failing to let central laboratories know that there will be a mobile health element of a trial could negatively impact aspects of the trial that require tailored setup for home visits. These aspects could include, for example, the use of harmful chemical additives in sample processing, the use of refrigerated centrifuges or complex sample processing instructions (eg, peripheral blood mononuclear cells (PBMC) isolation) that may require specialist equipment and/or extra training.
In addition, mobile health vendors usually have to wait for the central laboratory to finalise its lab manual before starting to develop its training materials. Early collaboration would allow for these documents to be built in parallel, thus reducing start-up timelines and avoiding potential process discrepancies further down the line.
When sponsors/CROs understand the interaction points between their various service providers, they can mitigate a host of potential delays. With regards to central laboratories and mobile health providers, one such example is sample queries.
Most laboratories will send all their queries to sites, who then have the task of forwarding them on to mobile health vendors. Mobile health vendors then contact their field workers to resolve the query. Two approaches can help to make this more efficient. First, if site personnel can contact home care workers directly, a step can be saved. And second, if labs can create home visit kits and separate visits in their laboratory system, it may be possible to direct queries to home care workers, again eliminating the extra step.
Right place, right time logistics
When mobile health providers are not in direct contact with the central laboratory, they may not be aware of the contents of central laboratory sample collection kits. This can lead to missing supply items which may prevent visits from taking place or samples from being collected.
As such, a lack of communication between laboratories and mobile health providers can delay scheduled visits and lead to avoidable repeat visits, all of which can mean missed datapoints and increased costs.
Again, early engagement with an open line of communication is the answer. When logistics of laboratory materials, such as pregnancy tests, 24-hour urine containers, and stool sample collection kits, are being decided, it is essential for central labs and mobile health providers to be aligned to ensure nurses have the right equipment in the right place and at the right time.
This need for alignment extends to the delivery logistics of site or visit specific sample kits, ie. whether supplies will be delivered by the mobile health depot or the clinical trial site.
Mobile health providers and labs also need to collaborate to ensure the instructions provided to the nurses are clear, easy to replicate in a patient’s home and preserve sample viability. This is essential for preventing delays in sample testing and data release, and for minimising the risk of samples being discarded.
When it comes to returning the samples to the laboratories, it is essential that mobile health providers and central labs assess lab opening times, courier capabilities and sample stability to ensure that sample viability is preserved, and any reporting timelines are met.
Some mobile health companies manage logistics vendors and others do not. For those that do not, strong coordination with the sponsor, CRO, and laboratory are required to prevent confusion regarding the holder of logistics budgets.
Any delay in agreeing on this essential information between vendors can hamper study setup efforts, leading to increased costs and longer lead times.
Direct communication is the most efficient solution.
Towards a joined-up future
DCTs and hybrid trials may be the future of clinical research, but only if we learn how to embrace their benefits while avoiding their pitfalls. One such challenge is the disconnect between different key stakeholders on any one project.
The contracting process for mobile health can vary. Sometimes sponsors/CROs contract with mobile health providers, sometimes CROs do, and sometimes labs hold the contract. Regardless of the contracting methodology, communication and coordination between the lab and the mobile health company is critical.
A lack of interaction between central laboratories and mobile health providers can delay study set up and negatively impact laboratory data quality – negating many of the efficiency benefits DCTs and hybrid trials have to offer.
Early and meaningful collaboration between vendors provides a way to overcome this barrier. Sponsors/CROs, mobile health providers and central labs are all aligned around how home visits can help reduce patient burden. Going forward we must all do better to align on planning and execution.
DDW Volume 24 – Issue 1, Winter 2022/2023
About the authors
Tom Brazier, is Director, Decentralised Clinical Solutions, mdgroup. In his role as head of Decentralised Clinical Solutions, 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.
Stephanie Larimer, is Decentralized Trials Solutions Manager, Q2 Solutions. After a brief tenure as a biology teacher, Larimer transitioned into the clinical trial laboratory space at Q² Solutions and has established herself as a successful global project services professional across central labs.