Televisit image courtesy of Medable
The use of decentralized clinical trials (DCTs) exploded during the pandemic, but quantifying their financial benefits has been elusive.
Medable (Palo Alto, California), the maker of a cloud-based DCT platform, has announced that DCTs can accelerate clinical trial timelines and lead to significant cost savings.
Medable and its research partner, the Tufts Center for the Study of Drug Development (CSDD), found that for Phase 2 studies, a standard DCT deployment yielded a one-to-three month time savings over a traditional Phase 2 study. In addition, a DCT yielded a financial benefit that is up to five times more than the upfront investment.
Time savings for Phase 3 studies were similar, while the net financial benefit was up to 14 times more than the upfront investment.
To learn more about the recent research, we spoke with Dr. Pamela Tenaerts, chief scientific officer of Medable.
Dr. Pamela Tenaerts
Drug Discovery & Development: Can you share more about the financial modeling for decentralized Phase 2 and Phase 3 trials in the research from Tufts Center for the Study of Drug Development (CSDD)?
Tenaerts: Joe DiMasi of Tufts CSDD at the Tufts School of Medicine led the financial modeling and analysis. DiMasi is best known for his calculation of the full cost to bring a drug to market, a figure commonly used as an industry benchmark.
Medable was privileged to engage and work with this expert Tufts team and provided a portion of the data used in the analysis. Tufts drew from published benchmarks and their extensive repository of data gathered over many years of collaborating with industry leaders and tracking key metrics about the drug development industry.
Full details around the modeling and analysis will be a part of the peer-reviewed publication, which is in progress.
Drug Discovery & Development: What is your view of the current state of DCT adoption?
Tenaerts: Nothing has helped lessen or remove the barriers to DCT adoption like COVID-19. All stakeholders in drug development, from sponsors to service providers to tech companies to sites and patients, have been forced to modify or reconsider the standard approach as a result of the risks presented by COVID-19. Many industry leaders are committed to not returning to the traditional approaches that served us for decades but instead learning from what was achieved in 2020 and 2021 and incorporating those into clinical trial planning going forward. It’s an exciting time to support this evolution – especially as recent reports indicate a willingness of patients to participate in trials that offer greater flexibility. That’s a major win, as anything that drives greater patient participation solves one of the biggest barriers in clinical research. Conversely, a recent survey of sites released by SCRS suggests that increased technology has increased the burden on site staff who need to spend extra time learning and managing various new solutions. Collectively, we need to continue to make technology more intuitive and reflective of the needs of end-users to increase efficiencies and realize the broader benefits of decentralized clinical trials.
Drug Discovery & Development: How mature would you say this trend is of DCTs shifting more clinical trials to community settings?
Tenaerts: Encouraging news from a recent Tufts CSDD report noted, for the first time in years, that we didn’t see the usual attrition in principal investigators (PIs) that has been a hallmark of the industry for the last decade or longer. Additionally, we are observing an expansion of research into healthcare, driven partly by community physicians and physician groups looking to provide more treatment options to their patients by offering the opportunity to be part of the research done locally. We are seeing new types of healthcare providers like retail pharmacies and community clinics developing new models to provide access to clinical trials to the people in the community. We have also seen efforts like accountable care organizations (ACOs) use clinical research-as-a-care options as a way to expand access to clinical trials.
Drug Discovery & Development: How important do you think collaborative data sharing related to DCTs will be for pharma innovation?
Tenaerts: One of the silver linings of the pandemic was the tremendous collaboration across the scientific community, as reported in a FasterCures publication. It is unprecedented to have scientists within the U.S. and across the globe working collaboratively to solve the biggest public health crisis of the last 100 years and the rapid development and delivery of mRNA vaccines in particular. These efforts showcase what is possible when we all work together. Medable supports ongoing and greater data sharing efforts while, of course, protecting the confidentiality of participants and respecting the competitive nature of our industry.