The clinical trial industry has seen big change recently, with the Covid-19 pandemic accelerating a shift to decentralised trials. This enables patients to still participate in studies while isolating at home. Telemedicine processes, such as in-home dosing, virtual visits and remote data collection, are deployed and may be combined with in-clinic sessions if a hybridised model is followed.
The decentralised clinical trial (DCT) concept has existed for many years but it had not yet been widely adopted. Then, the pandemic presented the perfect opportunity to operationalise the model at-scale. Many advantages of the decentralised model emerged, including that patients were able to continue participating in trials at home and still connect with physicians via remote visits. Many trial managers were able to continue recruitment while retaining existing participants by pivoting to decentralised trial designs.
“Recruiting eligible patients to participate in clinical research has always been a rate-limiting step for clinical development,” says Sheila Rocchio, Chief Marketing Officer at eClinical Solutions. “The DCT models are a chance for participants to be brought into the research pool that would not be able to participate in traditional studies which, due to convenience and physical proximity, rely primarily on site-based visits. There is a lot of excitement across the industry about decentralised trial designs, and the ability of technology infrastructure to bring more patients to the research process. It will build on the positive press and awareness for clinical research that’s grown and been publicised by the Covid-19 vaccine development and rollout.”
The industry’s rapid adoption of a completely different way of conducting trials also presented many new challenges for researchers. Using processes that differ from the traditional clinical trial model means data is captured and analysed differently, and data managers must adapt to these new methods rapidly.
“To realise the full benefits and capabilities of the decentralised trial, you need to think through it holistically and make sure you start with the end in mind,” Rocchio explains. “Many researchers are thinking primarily about the patient experience, including protocol designs and technology platforms, along with the regulatory impact and more practical, logistical aspects, like shipping devices to homes and last mile connectivity. However, once data is collected from different systems it stills needs to be reviewed by data managers and clinical scientists. It must be standardised into industry formats and analysed for safety, efficacy and, eventually, submission. Thinking holistically about data capture, interoperability, review, monitoring and analyses is an important component of decentralised trial adoption.
Don’t leave your data behind
Advancements in digital technologies have been a key enabler of DCTs. From mobile communication technologies to physiological monitoring devices (or ‘wearables’), a range of patient-centric data collection technologies can now be deployed from a patient’s home. In many cases, these allow for near real-time monitoring of patient safety, with the possibility of even better insights. This, in turn, has increased the volume, variety and velocity of data that’s available to measure patient experiences with new therapies.
Rocchio stresses the importance of an holistic approach towards integrating new data sets into a comprehensible view for stakeholders. “The rapid adoption of decentralised trials, which come with new technology platforms, connected devices and virtual visits, creates yet more data, that must then be handled on the back end,” she explains. “That can put additional strain on the system if you don’t have the proper infrastructure. If you’re just thinking through the front-end experience, but don’t think about who’s consuming, reviewing, integrating and analysing that data, you’ve missed the full picture, and you might cause a bottleneck to occur further along in the process.”
The transition to more trial data being electronic also changes data monitoring requirements, and expectations around source data verification. Risk-based approaches, that rely on predictive analytics and involve key risk indicators (KRIs), will become more important. Analytics that detect data anomalies – such as incorrectly calibrated measurements, or time inconsistencies – will help reviewers to sort through the data in a more methodical and automated way.”
Centralise your data
Another important consideration for decentralised trial strategies is where data gets assimilated and stored. “The data management and medical review process is still very EDC-focused, although the majority of data – more than 60% – now comes from outside electronic data capture systems,” says Rocchio.
For data reviewers, having one centralised platform that can comprehensively review all sources and then visualise integrated sets of trial data, is essential. Developed by eClinical Solutions, elluminate is a centralised data platform that collects and manages data from all sources, including decentralised systems, labs, biomarkers, eCOAs and EDCs. Data must be centralised on the platform before it is visualised and acted upon, and elluminate helps reviewers do both.
With elluminate, one integrated platform automates data ingestion across multiple sources, detecting conformance to standards while also providing analytics, data review exception listings, issue management and patient profiles. It provides data managers, medical monitors and clinical trial managers with risk-based quality management for faster reviews, more effective oversight, and faster time to insight overall.
Many lessons have been learned about DCTs over the past year. While the model still requires further streamlining and knowledge sharing, there is tremendous opportunity for benefit across the industry. Considering how data from DCTs is going to be assimilated with other trial data sources, and how it will be reviewed for quality and safety, and incorporated into analytics that both assess and predict operational risk with platforms like elluminate, is an important part of the DCT story. Platforms like elluminate encourage further DCT adoption, and help to build on the momentum created during the pandemic for better clinical development processes for all those involved in bringing new therapies to market.