Initial Results of Real-World Evidence Pilot Study Published in JCO Clinical Cancer Informatics

BOSTON, Aug. 6, 2019 /PRNewswire/ -- COTA, Inc., a healthcare technology company that uses real-world evidence (RWE) to bring clarity to cancer care, has announced its participation in a pilot program led by Friends of Cancer Research (Friends) focused on advancing the understanding and applications of RWE in oncology research. In addition to COTA, nine other healthcare research organizations and additional stakeholders are participating in the program.

The initial paper, "An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non-Small-Cell Lung Cancer," was authored by COTA, Friends of Cancer Research and other experts across the industry and was recently published in JCO Clinical Cancer Informatics. The pilot study explores how well findings from six RWE data sources match the findings of randomized clinical trials (RCTs) for advanced non-small cell lung cancer (aNSCLC).

Researchers used data from administrative claims and electronic health records to assess real-world endpoints and the extent to which these relate to similar endpoints in clinical trials for immunotherapy-treated aNSCLC. The findings demonstrated that real-world endpoints are generally consistent with each other and with outcomes observed in RCTs, demonstrating the potential validity of real-world data to support regulatory and payer decision-making. The findings will be presented at this year's 8th Annual Blueprint for Breakthrough Forum on September 18th.

"As the availability of real-world data continues to grow, we need to better understand how this information can be applied alongside clinical trial data for patient care and regulatory decision making," said Andrew Norden, MD, Chief Medical Officer at COTA and co-author on the study. "We're honored to collaborate with others across the industry to drive this research and the application of RWE. Thank you to Friends of Cancer Research for taking the lead on this important work, helping to improve overall cancer care."

Alongside partners like COTA, Friends is continuously trying to promote a better understanding of RWE. If interpreted and used appropriately, RWE can fill evidence gaps about the performance of devices and drugs in a real-world setting, including under-represented populations in clinical trials. This initiative includes three proposed objectives:

    --  Describe demographic and clinical characteristics of patients with
        aNSCLC, which will provide a baseline understanding of the similarities
        and differences among the datasets.
    --  Evaluate select real-world endpoints among PD-(L)1-containing frontline
        therapy regimens to assess the ability of real-world endpoints to
        measure differences in treatment.
    --  Develop a framework proposal to assess performance of real-world
        endpoints in a given dataset evaluating the robustness and validity of
        real-world data (RWD) to support the integration and utilization of RWE
        in regulatory decisions.

"RWE is an important tool for continued learning about treatment outcomes over time," said Dr. Jeff Allen, President & CEO of Friends. "This partnership explores the potential use of different endpoints derived from electronic health data, and demonstrates how different data sources can reproducibly provide important information on patient populations often excluded from clinical trials."

About Friends of Cancer Research
Friends of Cancer Research (Friends) drives collaboration among partners from every healthcare sector to power advances in science, policy and regulation that speed lifesaving treatments to patients. For more information, please visit www.focr.org.

About COTA, Inc.
Founded by doctors, engineers and data scientists, COTA is committed to bringing a patient first approach to cancer care through the use of real-world evidence. The Company organizes fragmented, often hidden data from the real world to provide clarity in cancer care. Combining clinical expertise in cancer with proprietary technology and advanced analytics, COTA's platform helps inform decisions and action in oncology. COTA partners with providers, payers, and life science companies to ensure that everyone touched by cancer has a clear path to the right care. To learn more about COTA and how to make better decisions with the right data, visit cotahealthcare.com.

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     Jaimee Ryan                           
     Melissa Brouillette



     COTA, Inc.                            
     Next Step Communications



     Jaimeeryan@cotahealthcare.com         
     Cota@nextstepcomms.com



     617-733-5509                          
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