Aside from shining a light on the complexity of drug development and increased efforts in drug repurposing and de novo drug development, the Covid-19 pandemic saw decentralised clinical trials (DCTs) brought to the forefront as a solution to the socially distanced roadblocks of the time. Having scaled the walls and surmounted the hurdles, it is decentralised solutions and not DCTs that look to be the future of clinical trials.

The rise of decentralisation can largely be attributed to its necessity within circumstance. However, a post-Covid environment has allowed the field to reflect on the workings of DCTs and adopt the most feasible and promising features of the trial modality, says Maria Harrison, Vice President of Operational Capabilities at contract research organisation Parexel.

Elements of DCTs are looking to be a silver lining of the pandemic. Now it is down to the field to continue evolving the definition of sites, develop more advanced technological solutions, and optimise the role of decentralisation in clinical trials.

Hybrid, the new normal

Though DCTs gained momentum during the pandemic, the idea of decentralisation has been around for a long time. Moreover, the extent of its applicability in trials can be divided into three phases: pre-Covid, Covid-19 pandemic, and post-Covid.

Pre-Covid was marked by innovation, namely pushing how far a trial could move away from a clinical site using different solutions, technologies, and site models, explains Harrison. For many years, the industry fixated on DCTs, adds Scott Palmese, Executive Director of Decentralized Clinical Trials at Worldwide Clinical Trials.

“Every company was trying to figure out how everything could be virtual, or everything can add technology, and it never really stuck. It was kind of the exact same conversations, and nobody really wanted to make the investment to progress in that space,” said Palmese.

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While prior evaluation of innovations such as e-consent and Home Health facilitated the implementation pathway of decentralised solutions during the pandemic, the challenges of supercharging to “full force” on short notice became apparent during this time, Harrison adds.

The industry is at a point today where stakeholders and vendors are taking a step back to reevaluate which elements of decentralisation worked and which fell flat.

According to Harrison, what has become increasingly apparent is that DCTs do not exist. “What I’ve seen in this post-Covid environment, is that there is no such thing as decentralised clinical trials. Today’s clinical trials have many decentralised clinical trial solutions that perhaps we did not see during Covid.” The emphasis on decentralised clinical trials becoming fully decentralised or applying decentralisation to every study has become a non-starter, adds Palmese. 

The industry is shifting towards a new norm – the hybrid model, where certain decentralised elements are incorporated into studies, but only in ones that make sense, Harrison and Palmese agree.

Challenges of decentralisation

Patients are an important stakeholder, and the start of decentralization is largely attributed to increasing patient engagement bringing clinical trials to patients, says Harrison. However, decentralisation places a heavy burden on sites—which are also significant stakeholders in clinical trials—that have subsequently voiced a negative post-pandemic response to decentralised solutions because of these burdens.

Post pandemic, there seems to be a reverse trend for decentralisation where some pharmaceutical companies are pushing back on some additional costs of decentralisation that were a necessity during Covid and sites are often not excited about an additional “technology bloat” in studies, says Palmese.

Ram Raju, former senior vice president and Community Health Investment Officer at Northwell Health agrees that the industry is seemingly reverting back to its normal practices.

“Principal investigators are very much afraid about the lack of control of the patient population because they think the clinical trials do not have enough oversight. The second part of this is that they also believe that patients may not use some of the technology correctly and create patient safety issues,” Raju explains.

While technology has its setbacks and can sometimes lack the precision of human action, there are areas in which technology surpasses human error, he adds. The “anecdotal” lack of oversight and the concerns over patient interaction with technology seems to be a blanket for a separate concern of how elements of decentralisation, such as technology, will impact the job market, adds Raju.

“In this country [US], the cost of human service always goes up while the cost of technology is always coming down. Eventually, intuitively, the cost will be lower in the long run,” adds  Raju, who was a panellist at the 15th Annual Outsourcing in Clinical Trials East Coast conference. Ultimately, the aim is to do more with less money.

As per the experts, this leads the industry in the current “fit for purpose” direction of decentralisation that emphasises minimising burdens for sites and maximising benefits for patients.

Fit for purpose

Because every protocol is different, there is no standard protocol design to base every hybrid trial on, says Palmese. Patient burden should be evaluated upon each visit, with decentralised elements potentially being included on a visit-by-visit basis instead of on wholesale for an entire study, he adds. When designing a protocol, the trialist must think about the solution, the patient journey, site, and the applicability of decentralisation, which is easier to do in some therapeutic areas than other.

Clinical Trials Arena’s exclusive DCT Tracker analysed that in H1 2022, the top therapy area for DCT adoption was metabolic disorders, followed in sequence by central nervous system (CNS), genetic disorders, infectious disease, and hormonal disorders. According to Palmese, there is good reason why decentralisation has more commonly been applied in these indications, and it comes down to how trials in these indications are designed.

Oftentimes with CNS conditions such as Alzheimer’s disease, the studies are designed to be longer because changes in disease progression are slow and must be evaluated over a long period of time, which correlates with longer follow up periods. Additionally, these trials implement many rating scales and cognitive assessments, some of which can be conducted remotely because they do not require the “intense” treatment programs that are seen in oncology trials, says Palmese.

The key is flexibility, Harrison and Raju agree. It is to balance the collection of valid data and provide the patient choices to facilitate the trial process. However, this must all be done with regulatory aspects in mind, added Harrison, who highlighted the impossibility of implementing one method of e-consent across geographic boundaries.

Clinical trials must be mindful of regulatory guides and consider how technology such as e-consent is deployed, how it is used to assess data, and how the data is managed; and how these processes are carried out varies from country to country, Harrison says. What trials need to do is learn how to work within the rules and write decentralised solutions and protocols in ways that limit biases and allow all involved stakeholders to reap the most benefits.