• The decentralised clinical trial (DCT) tracker entails an exclusive taxonomic approach to the identification of decentralisation methods across thousands of drug trial public records.
  • Its quarterly updates advance the understanding of the decentralisation elements being used by sponsors and CROs across multiple therapy areas and trial attributes.

The clinical trials industry remains intrigued by the promise of DCTs, arguably one of the most discussed topics in the clinical trials space in recent years. According to Decentralized Trials and Research Alliance’s (DTRA) Glossary released last year, a DCT is a clinical trial that utilises technology, processes, and services that minimise or eliminate the need for patients to physically visit a traditional research site.

Initially triggered by the need to rescue ongoing clinical trials during the Covid-19 pandemic, the adoption of decentralisation components has been increasing substantially. Now it is time to trace how the industry solidifies some of the decentralisation approaches and incorporates an a priori DCT mindset into day-to-day trial planning and execution.

Discovering DCT trends is valuable because this can pinpoint which elements are practical and which are not, says Nico O’Kuinghttons, vice president of decentralised clinical trials at Huma, a healthcare technology company. “It is important to see what piece of the puzzle will bring efficiencies.”

 

The use of decentralisation in clinical trials accelerated during the pandemic but slowed down more recently.

The fastest growing form of decentralisation was digital data collection up until 2021.

Although the adoption has slowed down, GlobalData identified 296 trials initiated during 2022 that utilised digital data collection, compared to an average of just 20 per year between 2010 and 2016.

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By GlobalData

Remote 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 this has slowed in the last year, their use has increased from an average of 50 per year between 2010 and 2016 to 261 in 2022.

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 2022.

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 2022.

In comparison, for telemedicine – the most frequently used form of decentralisation – there were over 500 new trials in 2022.

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.

 

Overall adoption trends

While Covid-19 lockdown measures made decentralisation an obvious answer to keep clinical trials running, the response was not immediate. The disruption of non-Covid-19 drug trials was severe across the board, regardless of DCT components being used. However, throughout 2020, more and more trials utilised decentralisation elements, especially in the Covid-19 field.

The use of decentralised components in drug trials peaked in 2021, with a 45% increase compared to 2020. Despite riding the wave of global adoption, the use of DCTs slowed down in 2022, though it remained significantly higher than in 2020. Looking forward and based on historical values of DCT activity between 2010 and 2022, it is estimated that DCT volume will rise by 17% by the end of 2023, surpassing the peak activity observed in 2021.

Uptake by disease area and decentralisation method

To further examine how the use of different forms of decentralisation varies by disease area and decentralisation method, Clinical Trials Arena took GlobalData’s Clinical Trial Database DCT subcategories and created six major DCT groups, each reflecting a distinct form of remote or virtual trial design: decentralisation to home or alternative sites, digital data collection, use of ePRO/eCOA/eDiary, remote monitoring (blood pressure and glucose), remote monitoring (via sensors, devices, trackers, etc.), telemedicine, and eConsent.

While this high-level DC categories may not be perfect (not all DCT approaches neatly fit into a single category) and the data may not be fully comprehensive (sponsors are not mandated to make the decentralised elements of their trial protocols public), this analysis provides an informative view on the landscape of decentralisation landscape by therapy area and DCT approach.

Clinical Trials Arena used this data to characterise trial decentralisation archetypes by therapy area. Telemedicine and remote monitoring via sensor, device, or tracker, were the most prominent decentralisation components across most of the analysed therapy areas. Dermatology and women’s health trials have most frequently included ePROs, eCOAs, or eConsent, while Covid-19 drug trials have been the most likely to move nursing or drug delivery away from traditional trial sites.

There are disease spaces where decentralisation seems yet to take off. While DCT in some therapy areas, such as oncology, may be hard to keep track of, it does not mean there is lack of involvement among players, adds Craig Lipset, co-founder and co-chairman of DTRA. It is all about intent – DCT allows the opportunity for patients to participate in trials who may not have access to a typical clinical trial site, he notes.

DCT leaders and laggards

Large commercial sponsors led DCTs in the past decade, but in recent years the landscape has become more nuanced. More universities, governmental organisations, and non-profit firms have become increasingly proactive in utilising decentralisation. This has been particularly evident for digital data collection, which is now twice as likely to be included in a trial led by an institution than a commercial sponsor. 

Academic centres are on the frontlines of scientific breakthroughs, so it is not surprising they are also increasingly becoming more engaged with DCTs, O'Kuinghttons explains. “They are openly engaging with their own peers to try new things,” he adds.

There is also an increase in private-public partnerships that also help this trend, notes Rachel Colite, decentralised clinical trials vice president at Cogstate, a neuroscience company. These types of partnerships are valuable as they help facilitate large-scale research that any individual institution may find challenging to execute, she explains.

CROs are pivotal players in trial decentralisation. A DCT’s success depends on how well the CRO has incorporated decentralised components in their business, which is a key selling point when working with sponsors.

DCT uptake by country

One of the key appeals to decentralisation is the potential to remove geographical barriers for clinical trial participants. However, running DCTs may be easier in some countries than others, and certain cultural differences might cause more burden to patients than traditional trials. For example, middle-income and East Asian nations have seen minimal growth in decentralisation.

This trend can be attributed to how friendly local regulators are on engaging with decentralised clinical trials, Lipset says. “There are countries whose regulators are particularly outspoken, progressive, and engaged on this topic,” he adds. And as such, they will attract trials with DCT elements, he says.

High-income countries tend to set the pace with new approaches as their economies have the means to adapt, O'Kuinghttons explains. Data privacy also needs to be a part of the DCT conversation, Colite adds. DCT uptake that requires data collection will have to be in places where data privacy regulations and compliance are also up to speed, she notes.

More insights on DCT adoption trends:

Decentralised paediatric clinical trials trending up but study execution critical

DCT Adoption Tracker: Clinical Trials Arena investigates which paediatric disease spaces are using decentralisation the most and why.

Direct to patient: rocky road to remote drug delivery in clinical trials

While an obvious solution to lockdown measures, sending study participants investigational drugs directly is still an untapped opportunity even in trials that would benefit. Clinical Trials Arena finds out why.

Beyond clinical trial design: factors that impact decentralisation

DCT Adoption Tracker: Clear regulatory guidance, existing healthcare infrastructure, and local culture are key influencers for swift decentralisation uptake.

Women’s health clinical trials: breaking down barriers through decentralisation

Women tend to be harder to recruit for clinical trials due to socioeconomic factors. But decentralised study designs help ease barriers to participation.

Remote clinical trial monitoring uptake rises but validation questions swirl

DCT Adoption Tracker: Clinical Trials Arena reviews the burgeoning trend on remote monitoring and look into regulatory know-how needed to ensure success.

DCT Adoption Tracker: Top 3 clinical trial decentralisation trends in Q1 2022

Clinical Trials Arena updates its exclusive taxonomic review of decentralised clinical trials with a spotlight on notable shifts in the past quarter.

DCT Adoption Tracker reveals top therapy areas using a decentralisation approach

Clinical Trials Arena updates its exclusive decentralised clinical trial (DCT) tracker with a spotlight on adoption by therapy area.

DCT Adoption Tracker: exploring trial decentralisation archetypes by therapy area

Clinical Trials Arena updates its exclusive DCT tracker and compares different decentralisation categories across disease areas.

Year in review: Who were the main DCT players in 2022?

Clinical Trials Arena reviews the companies and countries that mentioned decentralisation most often in their clinical trial protocols.