COTA’s service offerings used by top life sciences companies to support
regulatory and research projects.
COTA, Inc., an oncology real-world data and analytics company, today announced its expanded research and consulting services — Real-World Insights and Real-World Support. These additional services will leverage COTA’s deep real-world data (RWD) expertise to expedite cost-effective drug development, deliver actionable clinical insights, and support regulatory submissions.
COTA’s oncology RWD is already being utilized by leading life sciences organizations, cancer centers, and regulatory agencies, including the U.S. Food and Drug Administration (FDA), Bristol Myers Squibb, Miami Cancer Institute, and others for research and drug development. The expanded services will provide organizations with expert guidance and scientific support to conduct research, from protocol advisory and development, to analytic and algorithmic support and publications.
The results of COTA’s expanded RWD companion services were featured earlier this month at the Annual Conference of the National Comprehensive Cancer Network (NCCN). Miami Cancer Institute (MCI) worked with COTA to conduct a real-world study of first-line treatment patterns in HR+/HER2- metastatic breast cancer. The MCI team used COTA’s oncology real-world data to analyze a group of 135 eligible patients.
They found that the most common treatments for these 135 patients were ET-CDK 4/6i (55%), chemotherapy (21%), and ET (17%); 7% of patients did not receive any treatment (patient refusal, hospice, or death). There was an increase in the number of patients who received ET-CDK 4/6i from 45% in 2017 to 62% in 2019.
This utilization rate is actually in line with national trends, representing a very different finding than the claims data. The findings demonstrate the value of clinical RWD in understanding real-world treatment patterns and open the door to future research using RWD to investigate clinical questions, including treatment responses and patient outcomes.
COTA’s Real-World Insights service, led by an experienced team of regulatory, data science, and oncology experts, provides customers with customizable end-to-end study execution — from protocol development through manuscript publication. “COTA’s clinicians, researchers, and data scientists are masters of our data model. As a result, studies are able to be conducted expertly and with speed,” said C.K. Wang, MD, Chief Medical Officer at COTA, Inc.
In addition, COTA’s Real-World Support consulting services provide clients with input and advisory services throughout their project — ranging from straightforward analyses with partners experienced using COTA data, to more complicated needs, including cohort development, algorithm deployment, and developing studies in the regulatory setting.
“Real-world data is increasingly becoming more critical to supplement clinical trial research and accelerate the drug development process, especially following the latest guidance from the FDA,” said Miruna Sasu, CEO and President at COTA, Inc. “These new offerings will enable us to fill a deep data services gap and provide pharma organizations with specific insight into how best to utilize real-world data to drive next-generation approaches to drug development.”
For more information on COTA Real-World Insights and Real-World Support services, please visit cotahealthcare.com/data-services/.
