Digital technologies show signs of speeding patient enrollment and improving diversity in trials
Medable Inc., the leading technology provider for modern clinical trials, today announced that the Partnership for Advancing Clinical Trials (PACT) consortium in conjunction with the Tufts Center for the Study of Drug Development (CSDD) has produced compelling results from a new study. In total, 13 clinical trial sponsors and contract research organizations provided robust data on 60 clinical trials that deployed decentralized solutions and found that actual timelines beat planned timelines from first site activated to first patient enrolled, and from first patient to last patient enrolled.
In this initial dataset, sponsors used, on average, four DCT elements (or digital tools) per trial – – not just one – most often in support of study visit activity. Further, sponsors say they believe one-third of all protocol procedures, and half of all study visits, could be performed remotely.
“Data completion rates were high across most usage and performance outcome variables – affirming the mission and viability of the consortium – and promising meaningful and actionable insights as the dataset continues to grow,” explained Ken Getz, Tufts CSDD Executive Director and research professor. “This study will become an invaluable source for granular data on the hybrid use and impact of individual DCT solutions and is already showing encouraging signs of the potential benefits of these technologies.”
Early results of the PACT research also suggest that trials with DCT elements have more diverse study volunteers than those without, including a lower percentage of white participants, and higher percentage of Asian participants.
“The only way to know whether or not today’s clinical trial designs yield the results we want is to collect data,” said Dr. Pamela Tenaerts, Chief Scientific Officer at Medable. “At Medable, we are committed to supporting the Tufts/PACT consortium’s singular mission to capture key metrics. Already, we are seeing early evidence that digital technologies can help improve population representation in clinical research – a fundamental goal for us all.”
Medable, which ranked in the top 8% of software companies on the 2023 Inc. 5000, has deployed its software-as-a-service platform in more than 300 decentralized and hybrid clinical trials in 60 countries, serving more than one million patients and research participants globally. Customers have achieved impressive results – including 200 percent faster enrollment and 50 percent cost reductions. A Tufts CSDD study shows that, on average, decentralized trials can achieve net financial benefits from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million ROI and $39 million ROI for an investment on average of $500K in Phase II and $1.5M in Phase III trials, respectively.
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About Medable
Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Named a Leader in the industry by Everest Group and awarded Best Digital Health Solution by the Galien Foundation, Medable’s platform has been deployed in more than 300 trials in 60 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and ranked #398 on the Inc. 5000 in 2023.
About the Partnership for Advancing Clinical Trials (PACT)
PACT is a pre-competitive consortium of organizations collaborating to gather and manage empirical evidence to inform the adoption, use and impact of virtual and remote solutions supporting drug development planning, execution, analysis and reporting. Launched in 2023, PACT currently has 30 global members including major and mid-sized pharmaceutical and biotechnology companies and contract research organizations. The Reagan-Udall Foundation for the FDA co-funded the consortium as part of its Evidence Generation project.*
*This activity is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award of $400,000 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit FDA.gov.
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Contacts
Lisa Barbadora, Barbadora INK for Medable
+1 (610) 420-3413
lbarbadora@barbadoraink.com / media@medable.com
