Global Vice President of Life Sciences Product Strategy, Oracle Health Sciences
A shift towards decentralised clinical trials is helping gather rapid real-time patient data to help in the development of new drugs and therapies.
Patients are playing an increasingly pivotal role in clinical trials as technology facilitates remote and real-time collection of data to support development of new treatments.
COVID-19 has accelerated the pace of that change and expedited a shift towards decentralised trial models that leverage remote data collection technologies and processes to engage directly with patients, rather than in-person visits.
Jim Streeter, Global Vice President of Life Sciences Product Strategy at Oracle Health Sciences, says: “Clinical trials have become more patient-centred. That has been driven by new tools and methodologies allowing for direct access to the patient, which has increased the amount, as well as the frequency, of quality data collected.”
For over 20 years Oracle has provided core products for clinical trials and e-clinical systems to top pharma, biotech, and CROs, as well as emerging and mid-sized biopharma around the globe.
Streeter says: “We are finding ways to cater more to patients, rather than just doctors; using tools like health devices and accessing electronic health records directly.” Streeter adds: “This will bring a whole new set of technologies to help collect and operationalise this data.”
Working closely with its customers to develop a deep understanding of their needs and to help them meet the demands of this changing landscape, the company has developed a unified platform that allows for the rapid adoption of these innovations at scale.
There are challenges with decentralised trials including: keeping patients engaged and establishing their compliance, integrating new technologies to track high volumes of data as well as ensuring data reliability and quality.
“We hear the term decentralised trials, but from my point of view, they are just additional tools to engage with patients to increase the type and amount of data we get to improve clinical trials,” he continues.
“It means patients do not have to come in person to continue to participate in trials. There is still the need for adoption, but technically advanced organisations such as CROs, are helping to keep the momentum going.”
Patients do not have to come in person to continue to participate in trials.
That has also seen the implementation of artificial intelligence and machine learning systems to process and analyse the massive amounts of 24/7 data generated from mHealth devices such as mobile phones, patient apps and wearables.
“I think we are going to get a lot more realistic data – currently when patients visit a doctor it is a single point in time, and all we are seeing is that window but as we expand out into these bigger windows of data, we get to see what is happening on a daily basis.”
Streeter says patients will want options for clinical trials; some will use hand-held devices, while others may still prefer face-to-face visits. That flexibility may initially increase the cost of trials but over time that will come down as AI helps the understanding of the data.
“By giving patients a choice, more patients will enrol in clinical trials and stay enrolled,” he says. “Patients want to engage more, and they want to help us get drugs to market faster. We have learned a lot from patients over the last year. And patients have learned a lot too.”
Not only will this new dynamic help bring drugs to market faster, it will help terminate ineffective drugs quicker and lead to more personalised medicine in the future.