Decentralised trials: beyond the pandemic

The adoption of decentralised activities was a major factor in allowing clinical trials to continue during the early stages of the pandemic. Ben Hargreaves examines whether this adoption looks set to become a permanent feature of clinical trials moving into the future, rather than just supplying the tools to a temporary need.

Decentralised clinical trials (DCTs) have become a major talking point due to their ability to ensure that drug development can continue efficiently through the current pandemic. The arrival of COVID-19 meant that certain virtual technologies became essential for clinical trials to continue, bringing certain activities into the patient’s home and allowing for further activities to be conducted remotely.

This transition was already underway; however, with clinical trial activity greatly hindered at the early stage of the pandemic, the situation allowed clinical research organisations (CROs) and further stakeholders to introduce decentralised elements at a much faster rate than had previously been the case. The questions to be answered now are how far will this adoption of decentralised activities continue, how will the lessons learned from the pandemic be applied and how might the future of clinical trials change post-pandemic?

A steady movement

The major issues facing the formation of clinical trials are well-known: the expense, with each stage of trials costing in the millions of dollars, and the recruitment challenge to ensure patients join the trials and then remain with the trial for the duration, amongst other challenges. As a result, efforts have been consistently made to minimise these hurdles, which has involved looking towards how decentralised activities can be introduced into the clinical trial framework.

The opportunity to implement such solutions has evolved rapidly over time, as the public, in general, are much more comfortable using and living with technology that can assist in DCTs, such as smartphones or smart devices. As technology has improved, it is also increasingly viable to provide patients with such technology at a lower cost and that is more accurate or efficient than was previously possible.

As multiple factors have come together to spur greater interest in DCTs, the funding and investment that is taking place in the space is also increasing. Medable, a company working on the development of digital and DCTs, recently announced that it had raised $304 million in a Series D funding round, topping the $217 million it had raised through all of its previous funding rounds.

When speaking to pharmaphorum, Pam Tenaerts, chief scientific officer at Medable, outlined what is changing, in regard to how much interest is being generated in DCTs. “Prior to the pandemic, decentralized trials were gaining industry momentum for over a decade, but still deployed as pilots and proof-of-concepts instead of essential. With COVID-19, they became a necessity as clinical research sites shut down or stopped seeing non-COVID patients,” Tenaerts explained.

It is not just those companies that are directly involved in creating and marketing the products who were working on this type of solution, a spokesperson for Roche told pharmaphorum that virtual technology has been ‘critical’ to ensuring that clinical trials were able to run smoothly during the pandemic.

“Trial sites have been able to remotely conduct assessments, administer medicines, collect paperwork and even coordinate care at patients’ homes, cutting down the number of trips patients have to make to study sites. The COVID-19 pandemic provides an example of how technology can deliver better healthcare to patients,” the spokesperson stated.

A spectrum of activity

With the increase in the use of DCT activities, the task for stakeholders now is to determine what virtual tools can be applied more broadly and where there are limitations in their potential use. According to research by McKinsey, on a range of different decentralised tools, at least 48% of participants had attempted to decentralise trials to homes and alternative sites whilst 95% of had conducted electronic clinical-outcome assessments and electronic patient-reported outcomes.

A spokesperson for Vault Health, a provider of decentralised clinical research solutions, told pharmaphorum, “The pandemic ultimately proved that decentralized clinical trials can in fact yield better, safer, and faster health outcomes. With that said, there is no one-size-fits-all solution for every trial, and successful outcomes are dependent on which DCT tools and protocols are applied for a given situation.”

For instance, there is an expectation that fully virtual trials will be viable in only a specific set of circumstances, such as when the endpoints of the trial are suited to decentralised tracking and with a treatment that has few or mild adverse events. More likely, the uptake of proven tools will experience wider adoption and new technologies that provide supplemental information, such as real world data, will be added into an existing framework.

The spokesperson for Roche outlined what technologies the company is currently working on, in regard to creating new virtual tools: “We are developing disease-specific algorithms for use with wearable technologies to monitor patients with difficult-to-track, progressive diseases. By understanding a patient’s health metrics, day-to-day and over-time, care can be more accurately tailored to the individual.”

In terms of how the tools can be smoothly introduced into clinical trials, Tenaerts stated that the lessons from the pandemic period must be incorporated into future implementation, including ‘the good, the bad, and the ugly’, to “design trial protocols using digital-first principles, wherever logical, from conception and design of the study protocol – not retro-fitting them in later.”

Greater inclusion

One of the core benefits of DCTs is that it extends the reach beyond that of regular trials, which could also help address the longer-standing criticisms that they face. The spokesperson for Vault Health said, “Our industry has been slow to address accessibility, diversity, and inclusion. This is a big deal because understanding the safety and efficacy of treatments across different populations can help reduce disparities and advance equity in healthcare for all.”

This is where the advantages of DCTs can address the limitations of traditional clinical trials. With wider adoption of tools that can engage patients at home or reduce journeys to clinical sites, patients can be selected from a wider geographic area. Potentially, increasing the ease with which clinical trials can be completed will also encourage people from varied backgrounds to participate, for instance, not limiting participation based on work commitments. With the varied advantages offered by DCTs and the option to differ the levels of adoption within the trial itself, it seems clear to both pharma companies and those developing solutions for DCTs themselves that the advances achieved during the pandemic are certain to continue into the future.