Elevating Clinical Trial Quality and Accelerating Approval: Clario's Expertise Enables Breakthrough Alzheimer's Treatment
- Complicated clinical trials need to collect data across various "endpoints" to test safety and effectiveness. Without sufficient support and planning, this could span years and pose risks of data corruption and results that can't be reproduced.
- Clario ensured quality by overseeing the examination and analysis of more than 35,000 MRI and amyloid PET timepoints in vital Phase IIb and III studies for a new Alzheimer's disease drug. Additionally, Clario managed cardiac safety data collection and analysis across over 250 sites in 14 countries, including expert overread services for >20,000 ECGs.
- Through expert scientific assistance, standardization was promoted across multiple study protocols and all phases of development. This support played a crucial role in delivering comprehensive evidence necessary for evaluating safety and effectiveness.
PHILADELPHIA, Aug. 22, 2023 /PRNewswire/ -- Clario, a healthcare research technology company that delivers the leading endpoint technology solutions for clinical trials, has established a groundbreaking benchmark by creating comprehensive, science-driven standardized data collection on a global level. This achievement has expedited both conventional and accelerated approvals for innovative medications like Eisai's Alzheimer's disease treatment, LEQEMBI® (lecanemab-irmb).
LEQEMBI® (lecanemab-irmb) is only the second FDA-approved therapy in a new generation of Alzheimer's disease (AD) treatments, providing a lifetime of hope for afflicted patients and their loved ones. Its clinical trial program required long-term technical and scientific support to ensure the most effective collection and analysis of data to demonstrate the drug's safety and efficacy for the FDA's accelerated approval.
Clario provided support for confirming patient eligibility using both MRI and PET scans. Additionally, they monitored on-treatment patient MRI scans, assessed for Amyloid-Related Imaging Abnormalities (ARIA), and supported the drug's efficacy claim through volumetric MRI and amyloid PET SUVr analyses. Clario centrally received, quality checked, and analyzed over 35,000 MRI and amyloid PET timepoints for the lecanemab program. The amassed data during this period, exceeding 10 terabytes, is equivalent to streaming continuous music playback for 50 years. Clario also supported Eisai in providing cardiac safety devices to more than 250 sites in 14 countries globally, overreading >20,000 ECGs for the pivotal phase III study.
Standardized trial data collection was applied throughout the trial process to ensure the data was read uniformly and consistently within and across sites for accurate primary endpoint efficacy analysis, seamless transition between study phases, and accelerated setup times.
"I am immensely proud of our journey and collaboration with the Eisai team that spans over a decade, culminating in this remarkable achievement," said Joyce Suhy, Ph.D., Executive Vice President, Medical Imaging and Specialty Solutions, Clario. "Our dedication to scientific excellence has redefined the landscape of complex clinical trials for novel medicines. We recognized the critical role that precision and reliability play in these trials, especially in difficult-to-treat conditions like Alzheimer's disease. Together, we have not only raised the standards of data collection and analysis but also helped instill hope in countless patients and their families. This milestone further reinforces our determination to continue propelling innovation and making a transformative impact in the field of healthcare research."
"Variability kills clinical trials. This is especially true when it comes to novel medicines in under-treated conditions such as Alzheimer's disease. Alzheimer's disease is treated differently across the world, with different standards of care, different access to medicines and different cultural attitudes toward treatment. Unreliable, corrupted or non-standardized data can cause years of setbacks, not to mention pain for patients and their families and careers. Few companies can provide the proper scientific support and global scale for researchers who require this level of certainty in their trials. I'm incredibly proud of the Clario team's ability to deliver this for our customers and ultimately patients," said Ellen Street, Executive Vice President, Cardiac Safety, Respiratory and Precision Motion, Clario.
About Clario
Clario is a leading healthcare research and technology company that generates the richest clinical evidence in the industry for our pharmaceutical, biotech and medical device partners. Across decentralized, hybrid and site-based trials, our deep scientific expertise, global scale and the broadest endpoint technology platform in the industry allows our partners to transform lives. Clario has the only technology platform that combines eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. With 30 facilities in nine countries, Clario's global team of science, technology and operational experts has helped deliver over 24,000 trials and 870 regulatory approvals for over five million patients in 120 countries. Our innovation has been transforming clinical trials for 50 years.
For more information, go to Clario.com or follow us on LinkedIn and Twitter
Clario Media Contact
Duncan Cantor
Sr. Director, Corporate Communications
media@clario.com
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