Digital Health Platforms to
Empower Clinical Innovation
Novartis Pharma spearheads the transformation of clinical trials by
embracing decentralized trial models.
Presentation by Linus Kao, Senior DCT Expert, Novartis Pharma
Article by Dan Stanton, Managing Editor, Informa Connect
Novartis Pharma spearheads the transformation of clinical trials by embracing decentralized trial models.
Bringing a drug from research to market takes about 12 years and an investment of $1.5 billion. Around 60% of the overall cost falls over the six- or seven-year period where clinical trials are carried out. For a Big Pharma firm, the issue becomes more complicated as up to 500 trials could be running at any one time with numerous vendors and third parties involved.
With such a setting, Linus Kao, senior DCT expert at Novartis Pharma, told delegates how his firm is looking to break free of the costly and complex hospital-centric model and fully embrace the new paradigm of decentralized trials (DCTs).
“The traditional model has always been site centric, starting from the screening of the patient enrollment, all the tests and the conduct of clinical research are all done in the site, and it can take multiple years,” he said in Barcelona, Spain. “That's pretty much like a patient looking for like a treating chronic disease for quite a long time.”
The concept of DCTs has floated around for several years, but COVID-19 helped accelerate uptake of DCT concepts, including wearables, personal devices, and telehealth tools due to the strict limitations in travel and face-to-face contact enforced during the period.
Despite the advent of technology and the pandemic uptick, the percentage of industry-sponsored trials utilizing a DCT element remains low, 2.5% in 2022, according to Kao. However, clinical trial consultant and industry stalwart Craig Lipset questioned this during the Q&A, suggesting the 2.5% comes from clinicaltrials.gov, a very limited database of trials with no set protocol in place to list whether electronic consent or certain digital tools are being implemented.
Lipset cited one set of pre-publication FDA data that found over 80% of oncology submissions during the pandemic used decentralized methods, though admitted the truth falls between the two percentages, and most likely – particularly post-pandemic – on the lower end.
Whatever the figure, Kao said Novartis sits only below Pfizer in running the largest number of trials with DCT attributes but looks to embrace the model further and bring value to its clinical operations through an end-to-end, flexible, interconnected platforms strategy.
“Novartis is moving away from having a lot of point solutions to put into trial into a more collaborative approach,” he said. “We are open to having multiple vendors. We don’t need to lock ourselves into one platform because it’s clear there has not been a [single] fully capable platform in the past decade, and one is not likely to come up in the next three to five years. Most likely, we need to work with an ecosystem of qualified vendors, each one with their own strength in certain areas. But what we don’t want is to have multiple systems for the site and patients to use.”
Specifically, the proposed solution looks to embrace:
Operational simplification when dealing with multiple vendor systems plus their training and troubleshooting workflows;
Accelerated timelines for the vendor management, contracting, and study start-up process using a competent ecosystem of qualified vendors with their digital solutions seamlessly connected;
Increased data quality through a streamlined data flow that eliminates the hurdles of data exchange across closed vendor systems and ensures higher data integrity in large-scale studies; and
Improved recruitment and retention by simplifying the workflow and improving the study experience through having a single sign-on interface for study teams, site staff, and patients.
The benefits of moving to such a model stretch across the full clinical trial landscape, Kao said. Sites “where we see the most resistance” will encounter speedier patient recruitment and improved retention, while also acquiring experience in clinical innovations, he said.
Similarly, recruitment and retention improvements will benefit contract research organizations (CROs), while also improving patient diversity. CROs will also avoid overstretching current study teams with additional manual data management work, Kao argued.
For the patient, a fully realized DCT model should provide better access to clinical research specific to their health condition, while reducing the commuter burden, and enhancing their overall trial experience (subsequently keeping them in the study).
And for the sponsor, the more efficient model should bring drugs faster to the market, both substantially reducing costs and increasing the reputation of that pharma company in its mission to effectively bring life-saving medicines to the patient.
Kao acknowledged no pharma is an island, and thus Novartis must work with the full range of stakeholders to help implement this end-to-end DCT approach.
“We are open to collaborate with the vendor, with academia partners, [and] with CROs. We like to take your input and to see how we can work together to make the life of a site easier and also find easier ways to roll out digital innovations.”
