The next phase of decentralisation in clinical trials

The face of clinical research is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. The result is an improved experience for patients, whose participation no longer rests on long journeys to and from sites.

According to Daniel Tanner, chief commercial officer at Cerba Research, this patient centricity comes with exciting possibilities to improve trials for all stakeholders. “Clinical trials were really not optimised from the perspective of the patient, site orthe sponsor; they are increasingly cost ineffective, and they take a lot of time. Decentralisation has the potential to solve a lot of these challenges, particularly around participation rates but also importantly around diversity.”

Limited participation has been a thorn in the industry’s side for many years now, with low-enrolling sites a likelihood for virtually any study. As Tanner mentions, clinical trials have also been criticised for their lack of participant diversity. Socioeconomic factors can contribute to access difficulty for minority groups, and a shift to decentralised trials (DCTs) could lift this burden.

“Anything we can do to make it easier for patients to take part in a trial should really help us to recruit and retain patients better, which means studies can be completed faster and more cost-effectively,” he explains. “We can also optimise efficiency from a site perspective, which should mean better patient safety outcomes and data quality whilst potentially enabling them to participate in more research. For sponsors, the benefits are clear because they should be able to develop new therapies faster and more efficiently, which ultimately benefits all of us, particularly if they are more representative.”

There is data to support this possibility. According to an investigation by the Tufts CSDD, DCT deployments were associated with reduced trial timelines, as well as net financial benefits ranging from five to 14 times for Phase II and III trials respectively.[1]

Making the transition

The number of decentralised clinical trials has steadily increased over the past decade, rising from 250 in 2012 to 1,291 in 2021. They are expected to peak even higher in 2022, with GlobalData forecasting the industry to hold approximately 1,425 DCTs by the end of the year.[2]

With such profound benefits to be gained from decentralisation, some may wonder why their adoption is not higher. But the pharmaceutical industry has been naturally risk-averse and slow to adopt new approaches, says Tanner.

“Within such a tightly regulated industry, there is natural apprehension to being a first mover. While there’s huge returns when you get it right, there’s also enormous amounts of risk and continuous pressure concerning patient safety and data integrity which have inhibited our ability to move quickly.”

Despite this, during the Covid-19 pandemic, necessity really did prove itself the mother of invention. “Covid had an enormous impact not just on clinical trials, but the entire world,” Tanner remarks. “Everybody got used to doing things remotely. Drug development had to change. Many trials have had elements of decentralisation for some time, so there were things in place that meant that when the conditions precipitated it, there was a fairly quick move.”

Post Covid, he believes decentralised trials are now “part of the toolkit” and are likely to be deployed at least in some degree to “everything that we do going forwards”.

But there are still many challenges to confront on this journey. First, there’s the change management obstacle, which involves figuring out how to align all stakeholders on a new approach and understanding what processes need to change for a successful transition. At the end of the day, compliance and patient safety will be first and foremost for sponsors, but the complexity of some trials can make this difficult in a decentralised setting.

“Ecosystems, technology, regulations, and even cultures are all different from one country to another, which adds complexity,” explains Tanner. “The reality is that certain protocols, studies, and locations will lend themselves more readily to decentralised trials, whereas many others would prove incredibly challenging.”

Study teams are grappling with well-known obstacles on the operational side, too. These include the logistics of shipping investigative medicinal products to patients, with less control over the drugs being stored and administered correctly.

Arranging blood draws for biological testing has also become a challenge. Mobile nursing is the primary solution, but these services are limited in supply. High demand has raised their costs and caused scheduling challenges. Recent innovations in auto-phlebotomy technology could help patients draw their own blood in the future, meanwhile some central laboratories such as Cerba Research now offer dried blood spot testing services. This method involves using a small lancet to create a tiny incision. Small droplets of blood are then absorbed into a filter paper, providing an easier blood draw for the patient and an effective biosampling method for DCTs.  

Cerba Research is utilising its expansive network of city laboratories to draw patients’ blood in hybrid DCTs. With this approach, patients are in the safe hands of medical professionals without having to travel to a clinical trial site potentially many miles away.

Patient access is also an element of DCTs which can be achieved by being where the patient is, their network of routine diagnostic labs in France and Italy, has created new solutions enabling identification and recruitment of patients for clinical trials including Real World Evidence studies utilizing medical and laboratory data.

The next phase

Patient centricity has been the goal of the clinical trial industry for some time now, and the huge leap forward catalysed by the pandemic must now be built on. One example is the increasing focus on incorporating the patient’s perspective into new study designs. It requires teams to engage with patients directly. Making efforts to better understand trial designs through participants’ eyes will be an important action as the industry moves ahead to the next phase.  

“Decentralised trials are just one example of how as an industry we can move away from the traditional model of drug development,” believes Tanner. “Because we have this greater participation and these new research models, we can start to think bigger. We should not be viewing clinical trials as discrete events but try to take a more longitudinal approach to engage individuals with research on new drugs, vaccines, diagnostics, and biomarkers.”

Cerba Research is now working hard to define the position of medical laboratories within this wider vision. “At Cerba, it became apparent to our team that we can either be a passive participant in the market or we can actively try to create this new paradigm. At the start of Covid we updated our strategic imperatives to put decentralised trials as a key pillar,” Tanner says.

“We foresee a huge potential here for our laboratories to enable more DCTs, supporting traditional clinical research and more real-world research by creating an ecosystem which is built around patients.”

[1] https://www.businesswire.com/news/home/20220113005740/en/New-Study-Decentralized-Clinical-Trials-Can-Achieve-Net-Financial-Benefits-of-5X-to-14X-Due-to-Reduced-Trial-Timelines-and-Other-Factors

[2] The Movement Towards Decentralized Clinical Trials, GlobalData, October 2022