SCA can make certain randomized controlled trials more attractive to patients, and reduce recruitment and retention challenges
NEW YORK–(BUSINESS WIRE)–Medidata, a Dassault Systemes company, today announced that the Medidata Acorn AI Synthetic Control Arm® (SCA) has been awarded “Best AI-based Solution for Healthcare” in this year’s AI Breakthrough Awards.
The AI Breakthrough Awards program is the premier awards and recognition platform founded to recognize artificial intelligence related technology innovators, leaders and visionaries from around the world. This year’s program attracted more than 2,200 nominations.
Amid a crowded AI market and during the COVID-19 pandemic, Medidata has changed the world of clinical trials through its unique approach to external controls—the Medidata SCA. Medidata SCA is a type of external control that is generated using patient-level data from individuals external to the trial. Due to Medidata’s unique pool of more than seven million anonymized patient records, Medidata SCA offers the only external control group created with cross-industry historical clinical trial data.
“Because patients who are seeking treatment through a clinical trial have often already considered standard-of-care treatments and found them unappealing, many view an investigational drug as an opportunity for something better, particularly with rare and life-threatening diseases,” said Arnaub Chatterjee, senior vice president, Medidata Acorn AI Product & Ecosystem. “The possibility of being placed in a control group can dissuade patients from participating in a trial. However, an SCA can improve patient recruitment and retention by allowing for a study design where all or at least more patients can be treated with the experimental therapy. At Acorn AI, we are proud to be able to leverage our data and analytics capabilities to be presenting solutions that allow patients greater access to potentially life-saving therapies.”
In a precedent setting acceptance of a hybrid external control (combining synthetic control arm patients with randomized patients), the U.S. Food and Drug Administration (FDA) recently authorized a phase 3 registrational trial (one to be used for a potential new drug submission) using this breakthrough innovation. The FDA’s acceptance of this unique trial design will expedite completion of the study, allowing earlier access of a new drug for a disease with poor prognosis and high unmet need. Medidata’s recent whitepaper developed with the MIT Technology Review explores how synthetic controls enable new insights for clinical development and mitigate go/no-go decision risk.
Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.
About Medidata
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,700+ customers and partners access the world’s most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata.
About Dassault Systèmes
Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual experience twins of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production. Dassault Systèmes brings value to more than 290,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com.
3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French “société européenne” (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.
About AI Breakthrough
Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the AI Breakthrough Awards program is devoted to honoring excellence in Artificial Intelligence technologies, services, companies and products. The AI Breakthrough Awards provide public recognition for the achievements of AI companies and products in categories including AI Platforms, Robotics, Business Intelligence, AI Hardware, NLP, Vision, Biometrics and more. For more information visit AIBreakthroughAwards.com.
Contacts
Paul Oestreicher
External Communications Director
+1-917-522-4692
poestreicher@medidata.com