More than four years after decentralisation became a necessity in the clinical trials space, the sector is still finding its way around decentralised clinical trials (DCTs). And like any other paradigm shift, the journey has taken several turns.
Since early 2022, this news service has tracked the adoption of DCTs and observed the rise and fall in popularity in certain elements central to the decentralisation approach. Using data from GlobalData’s Clinical Trial Database, this news service tracked the numbers of initiated clinical trials employing specific DCT methods or tools each year. Elements like telemedicine, digital data collection, and remote monitoring using sensors, devices, or trackers are often tools used to decentralise a trial.
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The latest data indicates that although the adoption of DCTs slowed after the COVID-19 pandemic, it has still stayed well above the levels seen in 2020. Compared to the levels seen in 2022, there was a 2% drop in the number of all DCTs initiated in 2023.
The use of decentralisation in clinical trials accelerated during the pandemic but slowed down in the post-pandemic era. However, the adoption of decentralisation is expected to have an upward trajectory this year.
The fastest growing form of decentralisation was digital data collection up until 2021.
Although the adoption slowed down, GlobalData identified 310 trials initiated during 2023 that utilised digital data collection, compared to an average of just 20 per year between 2010 and 2016.
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By GlobalDataRemote monitoring of blood pressure and glucose levels – the most common form of decentralisation a decade ago – has seen a downward trend.
We have also tracked instances of remote monitoring using sensors, trackers and devices.
While their use slightly slowed down after 2021, their overall use has increased from an average of 50 trials per year between 2010 and 2016 to 306 in 2023, and is projected to further increase by the end of the year.
The use of ePROs, eCOAs and eConsent increased sharply from 2020 to 2021, largely driven by more widespread use among contract research organisations (CROs), but this has relatively stabilised in the last few years.
Decentralisation to home or alternative sites, which includes remote drug delivery and home nursing, remains rarely utilised with under 40 newly-initiated trials identified as including these elements in 2023.
In comparison, for telemedicine – the most frequently used form of decentralisation – there were over 650 new trials in 2023.
A decade ago, Phase III trials were the most likely to utilise decentralisation. But in recent years growth in use has been particularly strong for Phase II trials, which now make up almost one in every two decentralised trials.
Commercial sponsors used to lead the majority of decentralised trials.
But during the past decade, growth has been strongest for academic institutions and non-profits.
During the pandemic, many organisations used decentralisation as a “stopgap” measure and then went back to their traditional methods, says Kathleen Mandziuk, head of eClinical development and delivery, ICON. Jane Myles, program director at the industry organiation Decentralised Trials & Research Analysis (DTRA), likens the adoption curve to a “first-date scenario”. “Like any new thing, you have to try it a few times before it becomes sort of familiar,” she says.
However, Mandziuk says that there has been a shift in the other direction over the last 6–12 months, partly because the industry is realising that just putting technology in a clinical trial is not necessarily going to make it effective.
The proportion of DCTs is expected to rise again this year, even if they do not reach the peak levels seen in 2021, based on projections that rely on historical and current trends. DCTs in 2024 are expected to increase by 5.46% compared to 2023, reaching a total of approximately 1,450 trials.
Beyond the overall number of trials, the evolving adoption of specific decentralisation approaches tells a more nuanced story.
Data offers clues on trends
One of the most notable decentralisation trends involves the use of remote monitoring via sensors, trackers, and devices, which increased last year compared to 2022. While the remote monitoring of blood pressure and glucose levels was the most prevalent form of decentralisation a decade ago, the adoption of this virtual tool has seen a downward trend since 2021.
It is a matter of finding areas of real value, says Ben Casavant, CEO of Tasso, a diagnostic testing company. Data on glucose or A1C levels has often been recorded in electronic medical records (EMRs) and patients are wearing their own continuous glucose monitoring devices. “It’s areas where the EMR is lacking data that is where we can drive more value,” says Casavant.
If patients cannot use their own devices to record data, then organisations like ICON are employing patient concierge groups to help patients learn how to use a sponsor-provided device within a study. This can also help real-time remote monitoring of the trial, which can identify situations where technical issues may prevent data from being collected or if patients are having a difficult time using a device.
The number of trials using this type of remote monitoring is expected to remain steady in 2024, as per this news service’s projections. However, projections indicate that DCTs employing digital data collection will decline by a further 13.54% from 2023 to 2024.
“It’s that balancing act of saying where the innovations are needed, where they can actually enrich and show that quantifiable return on investment, and it’s not going to be a blanket solution everywhere,” says Casavant.
Myles cautions that the complexity of managing data collected via devices, especially if patients use their own devices, is often underestimated. There is a need to balance the burden on sites and patients, and still be able to collect evidence while assessing decentralised elements at the protocol stage, says Mandziuk.
Mandziuk says digital endpoints are the future of clinical research. This would mean not just using technology to help offset what would normally be done at the site, but seeing digital endpoints becoming primary and secondary endpoints in research, says Mandziuk.
Decentralised clinical trials are evolving to focus on the specific areas of value, says Casavant. For example, during the pandemic, telemedicine was the most frequently used form of decentralisation. Given the almost overnight need to decentralise trials and start studies when most patients could not easily travel to sites, this made sense. Consequently, as COVID-19-related travel restrictions and state-to-state telemedicine-related regulations eased, its use declined.
In the case of telemedicine, sites could use telemedicine from one state to another under more relaxed licensure needs. “All the conditions were more adaptive than planned, and so now we’re in a situation where you have to plan for these methods,” says Myles. With the need to handle a high volume of real-time data, the industry may have pulled back compared to the early adoption trends, but that is in an effort to conduct studies in a more planned manner, says Mandziuk.
Based on his discussions with pharma clients, Casavant is particularly excited about the potential to use of decentralised approaches during screening, which will allow patients more access to participate in trials.
Nonetheless, there has been a resurgence in the use of telemedicine in contrast with Clinical Trials Arena’s earlier predictions, which anticipated a further decline in trials using this element. By the end of 2024, the use of telemedicine is expected to rise by 8.37% compared to last year.
Similarly, the adoption of electronic patient-reported outcomes (ePROs), electronic clinical outcome assessments (eCOAs), and electronic consent (eConsent) has also stabilised following a decrease since their peak in 2021.
How to view DCTs
There is a desire to change how decentralised clinical research is viewed, beginning with what it is called. Myles calls them “flexible” trials while Mandziuk used the term “digitally enabled research”. Casavant says decentralisation, as its own separate thing, is going away. The time has come to take the lessons learned during the pandemic and apply them to areas with actual, quantifiable results, he adds.
Nonetheless, despite the challenges, Mandziuk says this (digitally enabled research/decentralised clinical trials) is how clinical trials will be run in the future. This will be more fit for purpose and will involve designing trial protocols around DCT elements.
“You can't talk to a regulator in any part of the world right now [and] they're not talking about improving patient access and decreasing patient burden. How you do that? You do it by decentralising your trials”, says Myles. She clarifies that this does not mean each measure will apply to every site or patient, but by identifying the methods that can be applied in a particular trial.
This has also meant subverting initial expectations. Initially, people assumed decentralisation would be the hardest in oncology, says Myles. However, Casavant says there has been a tremendous growth in the use of decentralisation measures in oncology trials where assessing progression at different time points is critical. For example, collecting data on traditional endpoints like progression free survival has been challenging in the traditional approaches, says Mandziuk. This becomes especially tough when the FDA mandates the collection of follow up data for 5–10 years.
However, the field is slowly collecting data to sway any naysayers. In a study presented at the American Society of Clinical Oncology, a group reported the findings of a survey of pharma companies that conducted trials that led to a drug approval. Of the 19 completed responses, almost all sponsors used at least one DCT element, with remote site monitoring, telemedicine, and remote laboratory assessments being the most common (Patel et al. Journal of Clinical Oncology, 42[16 suppl]).
The fully decentralised trial is not the answer, says Casavant. “It all comes back to how to make trials more efficient.”
Original development on the tracker done by Andrew Hillman
Previous research and reporting done by Urtė Fultinavičiūtė and Reynald Castañeda
More insights on DCT adoption trends:
Beyond clinical trial design: factors that impact decentralisation
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DCT Adoption Tracker: exploring trial decentralisation archetypes by therapy area
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Year in review: Who were the main DCT players in 2022?
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Direct to patient: rocky road to remote drug delivery in clinical trials
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