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  1. Analysis
June 16, 2022

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.

By Reynald Castañeda and Andrew Hillman

When it comes to integrating decentralised elements into a clinical trial, the patient is the centre of the issue. And when it comes to a trial site, more than the ability to implement a decentralised design, its capacity to attract study participants quickly is a priority.

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But other factors also need to be considered as they can help consistent use of decentralisation in multi-country trials and prevent delays in trial initiation.

Using GlobalData’s Clinical Trial Database, we looked for sites that use a decentralisation approach in trials. We found location hotspots and then drilled down the data to find the type of sponsors that were driving decentralisation at these sites, and the most common decentralisation elements.

Based on this data and experts in the field, we found recurring themes on the factors influencing decentalisation: clear regulatory guidance, a country’s existing healthcare infrastructure, and the local culture foreshadowing what’s palatable.

“While a protocol is the foundation [of a trial], the complexity [in execution] is driven by what is happening at the individual countries and sites. This could be affected by regulatory requirements or what investigators and patients are able or willing to do,” explains Worldwide Clinical Trials global head of regulatory strategy vice president Aman Khera.

Regulation influences decentralised clinical trials

A regulatory framework is one of the first considerations while designing a decentralised clinical trial (DCT). “It is a conservative industry, so there is a lot of attention on what they [regulatory bodies] say,” Allucent CEO Mark Goldberg says. It is not by accident that countries with regulatory authorities that are more proactive in decentralisation are also places where active research communities exist, adds IQVIA decentralised clinical trials regulatory director Eric Klaver.

Nordic countries such as Denmark have a firm and positive stance on decentralisation, notes THREAD CEO John Reites. Regulatory bodies in the UK, the Netherlands, and Poland are traditionally leaders that enable innovative, good-quality research, Klaver adds. Switzerland’s regulatory body and ethics committee released a position paper on DCT adoption last year, Khera says.

According to our findings, Switzerland has seen the sharpest increase in the proportion of trials with a decentralised approach. Between 2012 and 2016, just 1.4% of single-country trials include decentralisation but in recent years the figure has risen to 9.5%—the second-highest rate of all European countries. The first is the UK, and the third is Denmark.

Of recent single-country decentralised trials in Switzerland, more than half were sponsored by universities in Basel, Zurich, or Bern. In particular, the University of Bern has frequently incorporated telemedicine for its smoking cessation trials.

Academic sites in Switzerland are strong innovators in terms of decentralisation, Khera says. This is notable as not all academic trial sites are as agile as their counterparts in the industry. Application of a decentralised approach to non-commercial research can be a litmus test for identifying a fertile research environment, Klaver adds.

For further context, Reites says the incentive to decentralise is greater for multi-country trials than single-country ones. Decentralisation allows a trial to have a large geographic footprint and single-country trials might not need it, he explains. That said, academic centres usually sponsor single-country trials, which makes it easier to have regulatory body support, Goldberg notes.

Late decentralised clinical trial adopters

Some regulatory authorities are more conservative, reactive, and tend to focus on compliance with current regulations, making them more likely to be late adopters, Klaver says. There is growth in decentralisation in the Asia-Pacific region, but it depends on the country, Reites notes. For example, decentralisation in Japan is harder because of regulatory barriers, Goldberg adds.

In Europe, the Clinical Trials Regulation (Regulation (EU) No 536/2014) may help harmonise the regulatory stances among countries. Outside the continent, every country has its own approaches and consequently some have longer clinical trial start-up times, Khera notes. “[But] all regulatory bodies are collaborative and friendly—even if they might not have specific decentralisation guidance,” she says.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is updating the Good Clinical Practice (GCP) guidelines to Revision 3 (R3). There are more complex trials or studies with multiple sponsors, and guidelines and regulations are actively being updated to make sure this is harmonised, Klaver notes.

Local prior experience vital

A specific country or region’s experience in implementing decentralisation is also an influencing factor. For instance, the use of homecare and telehealth in local healthcare systems may influence their adoption in decentralised trials. “Customers [sponsors] look for experience data,” Reites adds.

Telemedicine remains relatively rare in clinical trials in middle-income countries. For example, GlobalData identified just 0.4% of recent studies with locations in China and 1.5% of recent trials with sites in India involving telemedicine. But South Africa is an outlier. Since 2019, 7% of trials with sites in South Africa have used telemedicine. Moreover, of all the multi-country trials initiated since 2019, 14% with sites in South Africa have been decentralised—the highest rate across all surveyed countries. GlobalData is the parent company of Clinical Trials Arena.

South Africa’s recent decentralised clinical trials have predominately been in Covid-19 and respiratory disease research. There was a big influx of Covid-19 trials in the country, and many had relatively simple trial designs, Goldberg says. In infectious disease trials, like those investigating vaccines, which are typically less complex, telehealth is a great modality, he adds.

Further, telehealth is culturally relevant in South Africa as its wide geographic area necessitates mobile connectivity, Reites says. If the trial is ideal for telehealth, and there is already infrastructure supporting that in the country, long start-up times can be alleviated, he notes.

As a point of contrast, it can be difficult to deploy telehealth in Europe unless it is already part of the healthcare system, Goldberg says. While some countries are investigating the possibility of using remote monitoring, countries like the Netherlands do not allow it, Klaver notes.

A country’s medical record infrastructure is also an influencing factor. In Poland, medical records are mostly paper and there is no legislation regulating electronic medical records (EMR), Klaver notes. In Australia and the UK, there is a mix of paper and EMRs, he adds. And in countries like the Netherlands and the UK, facilities use different systems of EMR. This is all in contrast to Denmark, where historical medical records are stored on a public health server.

Going back to Asia, single-country trials located in China are least likely to involve decentralisation, with fewer than one in 100 single-country trials having such an approach. It makes sense that decentralisation uptake for single-country trials in China is low, as these studies may be conducted in a central clinic that makes all the study design decisions, Reites says. On May 13, Clinical Trials Arena reported how China’s clinical trial activity is still mostly catering to its local industry.

Adoption of decentralised clinical trials is growing in Asia-Pacific countries, but not as quickly as in other regions, Khera says. There are cultural changes that need to be made: patients are used to seeing the doctor in person, but these trends are changing, even if not as quickly as in other countries, she adds. 

Another example of DCT being at odds with traditional practice is eConsent. From experience, much of Europe does not embrace eConsent, which is also the case in Asia-Pacific, Goldberg says. There can be regulatory bodies that still want the wet, ink signature even if they allow eConsent, Khera notes.

eConsent is not simply obtaining a digital signature—it includes a standard workflow involving study education and comprehension checking, which sets expectations for the trial participant, Reites adds. In some countries, clinicians prefer to provide the education themselves without technology support, he says.

Similar language allows for multi-country rollout

Overall, the use of decentralisation has risen dramatically during the past 10 years. Between 2012 and 2016, just 3.1% of single-country trials in the UK and 3.8% of trials in Australia used decentralised elements. But these countries are now considered leaders in decentralisation.

In Australia, 16.5% of single-country central nervous system trials, primarily university-sponsored, have been decentralised since 2019. Sleep disorder trials involving wristband trackers and telemedicine have been particularly common in Australia in recent years. Some 39% of single-country sleep disorder trials in Australia have been decentralised since 2019.

One possible reason is that these are English-speaking nations, and thereby clear destinations for expansion once an approach has been piloted in the US, Reites says. Further, the UK and Australia are top recruiters in clinical trials, he adds. Australia’s “zero-Covid” plan had insulated its local clinical trials industry from the pandemic.

While our data shows the US is lagging Australia and the UK, it could be that certain local trials do not publicly disclose their decentralisation approach. The DCT Adoption Tracker analyses 12 years of data based on clinical registry protocols, research papers, and press releases to find trends on the uptake of approaches used in clinical trials that are decentralised. 

Multiple factors affecting decentralisation

There is an enormous appetite to understand the penetration of decentralisation, Goldberg says. As the pandemic is shifting, the industry is stepping back to think about using decentralisation elements more thoughtfully, he adds.

But it will ultimately come down to where patients can be found, Goldenberg says. An individual site’s record of attracting patients comes first, and decentralisation can then further empower these sites to reduce the burden on patients, he explains.

A decentralisation approach that works in one country might not need to be used in another—it is not unusual for international trials to have some countries with a decentralised element and not others, Khera says. Even if there is patchy decentralisation among countries in the same trial, data integrity is likely to remain. “The data will still be uniform throughout. It is how the data is collected is different,” she adds.

As Reites concludes: “You don’t decentralise a trial because it’s the cool thing to do, but it should be the right thing to do for the trial to be patient-centric and go outside of geographic barriers.”

Takeaways:

  • Regulatory bodies showing support for decentralised clinical trials can make their countries attractive to host decentralised studies. But this is not a key factor in site selection, as the case for decentralisation can be made for all regulatory bodies if it makes sense for the trial.
  • Previous experience and existing infrastructure that supports a decentralised approach can ensure quick decentralisation. This is particularly true in countries where the start-up times can be longer.
  • But the caveat is that even with the right infrastructure, it still comes down to what investigators and patients are willing to do. There will be cases where even if the decentralised approach is okayed, more traditional methods will still likely be required in tandem.

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