Within the last decade, the way clinical trials are done has been revolutionised by technology. Pharmaceutical companies are embracing the power of new tools, from wearables to telehealth appointments, to transform timelines, milestones and, ultimately, patient outcomes.
Daniela Caiazza, Senior Director Clinical Services and Innovation at Asia-Pacific CRO Novotech, highlights that participants find it difficult to stay enrolled due to poor health in around 50% of clinical trials, and around 70% of patients live more than two hours from a research site, according to Medrio’s recent report The Rise of Decentralized Trials.
“The decentralised clinical trial (DCT) model addresses a lot of the patient needs that go unmet in the traditional model,” says Matty Notaro, COO at virtual research organisation ObvioHealth.
ObvioHealth has been running DCTs in the consumer health sector since 2017, but the Covid-19 pandemic has propelled the model in recent years.
“Covid-19 created a circumstance whereby restrictions for physical visits to sites impacted existing trials from not only a recruitment, retention and protocol compliance perspective, but also with the CRO or sponsor’s capacity to perform timely reviews and cleaning of data,” says Caiazza. “This has fast-tracked the emergence of DCTs. Sponsors and sites are looking to solutions to minimise patient disruption while identifying technologies that allow for the collection of high-quality data, meeting regulatory standards.”
According to GlobalData analysis, the use of wearables, sensors and tracking devices in clinical trials has been increasing consistently since 2015, to reach over 200 in 2021, with the biggest jump between 2020 and 2021.
Today, the technology continues to evolve and improve. Having started with the introduction of mobile apps, sites have come to explore decentralisation possibilities including telehealth visits, home healthcare agencies, and the integration of Bluetooth-enabled devices providing data from O2 saturation rates to EKG and EEG readings.
“30 years ago, there were many gaps and many inefficiencies in traditional clinical trial design,” says Notaro. “Now we’re monitoring patient safety with much more rigour, much more oversight. The efficiencies are incredible, and it’s very exciting for the industry.”
Driving data collection
“Virtual platforms, generally downloadable to the patients’ existing smart phones, make it possible for patients to report from their homes,” explains Caiazza. “By deploying mobile technologies, DCTs have the scope to also collect more data from patients over time than in a traditional site-based clinical study, providing data which is more akin to a real-world setting.” In DCTs, patients can record symptoms like pain as they are happening.
The systems for data collection are designed to include automated checks, to reduce errors, and notification capabilities, which help maintain patient engagement and increase compliance.
“Now, we’re introducing the automated ePRO, designed to reduce subjectivity from the data using image capture, audio capture and video capture. This gives us real-world evidence for our projects,” says Notaro.
Data is power, she explains: “It’s great for post-marketing surveillance studies, when clients are trying to make claims. All this data allows insurance companies to see how effective the product is and allows them to approve that drug.”
Today, even more advanced technologies are creating new possibilities across industries. Clinical trials are no exception, and machine learning and artificial intelligence are being increasingly used to facilitate data capture and analysis and develop novel outcomes. More devices with APIs can be integrated with DCT platforms, meaning studies can be set up quicker and participants are offered a more seamless experience than ever.
Technology has created more flexible recruitment and communication processes. Researchers can access a broader range of participants using digital platforms and social media, and the trial population is no longer dictated by the geographical location of the site. And by boosting contact with participants, researchers can improve compliance, one of the most fundamental elements of any trial.
“Not all studies can be fully decentralised, but just about every single project has aspects that can be done in a decentralised way,” says Notaro. The hybrid model for clinical trials, integrating elements of both traditional and decentralised trials, presents researchers with the possibility to fine-tune their trial design.
Mental health issues, behavioural diagnoses, metabolic diseases, endocrinology, and autoimmune disorders are some of the top fields for decentralisation, but areas like oncology are also taking advantage of what can be done remotely. “You’d be surprised how many study-related tasks can be done remotely,” says Notaro. “We’re now doing EKG, blood pressure, temperature, O2 saturation rates.”
As technological capabilities expand, so will the potential for decentralisation, Caiazza predicts: “In the short term, the most optimal studies to conduct DCTs are generally in those with well-characterized treatments with few adverse events in a mild indication, with end points suited to remote assessments,” she says. “In the mid to longer term, however, DCTs will be more commonplace and widespread, especially in therapeutic areas that require patient populations that can’t physically travel.”
As the rate of technological development continues to accelerate across all industries, the clinical trial space has enormous potential for improvement: good news for researchers and patients alike.
“As decentralised methods get adopted as standard practice, opportunities will open up for trials to be adopted not only by traditional site-based investigators but also ‘non-investigator’, community-based physicians whose previous exposure to research may have been limited,” says Caiazza. “This flexibility is truly putting the patient at the centre of research.”
“I expect to see even more technology, more devices and more outcomes being measured with technology,” says Notaro. “At the end of the day, the main goal is to get drugs to market quicker and get insurance companies to cover them so patients have access to those drugs.”
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