Optimised clinical research through decentralised trials

Not only did the COVID-19 pandemic bring lockdown rules and increased safety protocols, it also led to delays, reconfigurations, limited patient access, and other restrictions for life science research and development. However, one benefit is that it accelerated innovations underway to solve long-standing clinical process issues.

“The pandemic turbo-charged trial decentralisation,” says Caroline Redeker, senior vice president, corporate development at Advanced Clinical. “We were already incorporating home visits, ePRO, and other decentralised components. But when the new coronavirus hit, we had to find new ways of working with trial sites since they couldn’t see their patients in person, nor could we send our staff on-site to monitor.”

Leveraging pandemic insights and digital progress

The pandemic forced trial innovation across the board. “It completely changed how our clients and the agencies would let us work,” Redeker comments. “Instead of just for certain types of trials, we incorporated telemedicine and video broadly and increased other decentralised activities such as remote monitoring.”

In parallel, the pandemic accelerated digital advances that were already underway.

“It led to increased automation of the highly complex trial process, as well as improved access to information,” explains Moulik Shah, vice president, digital health at Advanced Clinical.

Before COVID-19, a lot of information would typically be recorded and stored on paper or in many separate systems that were not integrated. With vast amounts of data accumulating over time, locating and retrieving the correct details at the right time became challenging.

“Clinical trials involve a large number of individual steps, many of which used to be covered manually until only a short while ago,” states Shah. “Digitisation helps access and integrate data from a wide range of diverse sources in real-time. It brings tremendous efficiencies that drive trial decentralisation and clinical innovation.”

Value generation through decentralised trials (DCTs)

Will these improvements prevail post pandemic? Why would the industry not revert to tried and tested ways that served them for decades?

“Decentralised trial components offer too many benefits all around,” says Redeker. “You can’t unlearn what you’ve learned.”

The gained efficiencies, speed, and quality of results for trial sponsors are compelling. For patients, DCTs typically offer simpler more accessible, and convenient participation. For all, including healthcare providers, remote trial options generate data representative of real-world populations, resulting in targeted, personalised treatment opportunities.

“A lot of improvements will definitely stick,” Redeker adds. “The industry is already benefiting from different ways of thinking. The pandemic taught us to embrace new approaches. For every future trial, people will explore improved ways of conducting them – how to optimise both our methods and how we interact with site staff, investigators, and patients.”

“From a data perspective, we’ve seen a quality leap, too,” adds Shah. When information gets digitised and seamlessly integrated, this eliminates faults like duplicative data entry or transcription errors between systems. “We’re increasingly looking at a single source of truth.”

Taking the trial to the patient

However, DCTs do not only mean technology improvements. “For certain types of trials, we want to bring the trial to the patient rather than requiring travel to centres for their visit,” clarifies Redeker.

This can be achieved in diverse ways, such as leveraging mobile clinics, local pharmacies, or even targeting specific communities and groups. “A research structure may be set up around a patient’s home or primary care physician environment, where they can participate remotely with a principal investigator (PI) based somewhere else.”

Shah agrees: “Before decentralisation, the average trial participant’s journey was cumbersome. Many had to travel to distant sites, take time off work; often multiple times since visits would be scheduled around staff schedules rather than the patient’s availability.”

While DCTs can significantly improve the patient experience by enabling convenient participation, Shah explains, “They also help include patients from diverse backgrounds of relevance to a given disease or investigative treatment. This can strengthen submissions by representing real-world populations, also improving compliance and reducing attrition rates.”

Hybrid trials – the new gold standard

How should trial sponsors leverage these insights to optimise their research strategy?

“Your digital strategy should mirror and serve your overall clinical strategy,” guides Redeker. “Hybrid trials will be the gold standard for some time. Many aspects can be done remotely, and some fully decentralised trials are underway. But I don’t think it’s practical for the majority of studies to turn completely virtual; not in the near future.”

There are, of course, acute conditions and patients who need to be seen by a specialist in the clinic. According to Redeker, “Even those cases usually contain digital or in-home follow-up components that can be incorporated to facilitate the research, like electronic patient-reported outcomes (ePRO), clinical outcome assessments (eCOA), or other aspects of hybrid trials.”

Asked for types of research she would recommend DCTs for, Redeker lists chronic as well as rare diseases. “There are definitely chronic conditions where patients, sites and sponsors all benefit from efficient monitoring by wearables and other digital offerings, especially in later phase, registry, or quality of life studies collecting long term data.”

“Yet there are rare disease patients, too, who need to travel far to see an expert PI based at a prestigious academic centre, for whom home health visits or other ways of monitoring and connecting between clinic visits may bring significant relief and open the patient pool.”

Regulators enabling trial innovation

Regulators around the world have been open to how trials had to be adapted during the pandemic.

“It was great to see agencies accept a lot of the improvements we were making,” comments Shah. “We’ve come a long way. Just a few years ago, a lot of data had to be collected in paper form and adoption of technology has been historically slow in our industry.”

But things have changed since. “Today, we see the FDA and other agencies actively encourage the use of technology, for example, to enable greater diversity in trial populations. We value their openness to effective technology solutions and the productive collaboration with regulators across the globe.”

“With that comes an expectation, however, that research providers prevent any compromise of data integrity, patient safety, or other violations of trial quality,” Redeker explains.

Shah adds: “We also can’t drive technology solutions too aggressively.” The burden is shifting from patients going into a controlled setting to follow protocols, to patients leveraging a lot of smart technology at home.

The benefits though of this shift are intriguing. Technology facilitates accurate monitoring of patients’ real life. How do they act outside the controlled clinical setting? What influences them to make decisions or change behaviours?

“We need to be certain patients and sites are ready to accept new technologies. There is a fine balance to strike,” Shah explains. “That set of real-world information is critical to drive improved clinical outcomes.”

The future of clinical research

Redeker and Shah envision the immediate future of clinical research to lie in tailored solutions to fit individual research programmes. “Our approach to DCTs is flexible, modular, and scalable, adapting to trial needs and therapeutic area norms,” says Redeker. “Sponsors and CROs need to constantly deepen their understanding of new ways of working at both the site and patient level.”

In addition to improved data integration and seamless flow through the clinical research environment, Shah expects automation will continue to replace yet more repetitive manual processes. “And with rapidly increasing data generation and processing capabilities, technologies like artificial intelligence and machine learning show significant potential to revolutionise clinical research.”

Another clear trend on the horizon is that new technologies customised to patients will boost precision medicine.

“Then we need to intensify the matching of clinical research to standard of care,” he continues. “Over the next years, trials will be optimised to a point where there’s no divergence. We will build clinical programmes on standard of care, not create separate conditions.”

Conclusion

Against these trends, how should pharmaceutical companies, device manufacturers and CROs best work together to create maximum value?

“There’s no one-size-fits-all in clinical research,” Redeker says. “Each trial presents unique needs. As a strategic partner, we aim to work with trial sponsors early on to fully understand the programme and match its needs to tailored solutions ideally before protocols are written.”

“Collaborating early strengthens the opportunity to integrate the most beneficial digital and DCT elements to enhance clinical development strategy,” adds Shah. These strategies should not run separately. “One doesn’t exist without the other.”

“For optimal clinical research efficiency, patient experience and journey, digital health expertise needs to be embedded in the entire drug and device development process and certainly should guide clinical trial design,” Shah concludes.

Caroline Redeker, senior vice president, corporate development
Caroline Redeker, senior vice president, corporate development, has 30 years of experience in planning and managing pharmaceutical, biotech and medical device clinical research, creating successful partnerships with sponsor companies to add value to their programmes. Areas of specialty include clinical development and feasibility planning, site engagement and patient engagement strategies, decentralised trial approaches, and transition or rescue programmes.

Moulik Shah, vice president, digital health
Moulik Shah, MS, PMP, is vice president, digital health, at Advanced Clinical. Shah is primarily focused on identifying untapped opportunities to improve the patient journey, increase operational efficiencies and achieve cost savings in clinical trials – and on delivering these using innovative technological solutions.

Based on his broad experience in the avionics, telecommunications, power, medical device, and pharmaceutical sectors, Shah brings a unique perspective to digital health challenges. He has a BS and an MS in electrical and electronics engineering from the University of Illinois Chicago, and is the holder of two approved patents

Advanced Clinical is a privately-held, single owner global clinical research services organization, providing full-service CRO, FSP and Strategic Resourcing solutions for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. Visit our website to learn more about how we deliver a Better Clinical Experience: www.advancedclinical.com

Don’t miss your complimentary subscription to Deep Dive and our newsletter