Building a better ECA: 5 steps for submitting an ECA to regulators
In this post we look at the future of RWD in action and explore the world of external control arms (ECAs). Experts outline 5 steps to building and submitting an ECA to regulators.
Real-world data control arm provides new look into effectiveness of lymphoma therapies
Real-world data can uncover vital efficacy info for new treatments. In the development of an external control arm for lisocabtagene maraleucel in patients with R/R large B-cell lymphoma, Bristol Myers Squibb used COTA’s RWD.
What to know about FDA draft guidance on accelerated approval of oncology drugs
Are you up to date with the latest FDA guidance on accelerated approvals for oncology therapeutics? The FDA has just released draft guidance on the use of randomized controlled trials (RCTs) versus single-arm trials for the accelerated approval of oncology therapies. We’ve broken down what you need to know.
Baptist Health Miami Cancer Institute expands partnership with COTA.
Miami Cancer Institute has recently utilized COTA’s analysis of RWE to change its testing policy for breast cancer gene mutations. With the new technology, the institute has decided to test every patient diagnosed with the condition. Not only will this help with early detection, but it will also allow for more personalized treatment plans.
NCCN: Enabling real-world cancer research with real-world data from COTA
Real-world data assets are becoming increasingly vital in cancer research. And at NCCN 2023, COTA’s data sets are recognized in 2 studies, one focusing on HR+, HER2- metastatic breast cancer, and the other analyzing early-stage non-small cell lung cancer.
COTA, Inc. Forms Strategic Real-World Data Research Partnership with the Clinical Research Data Sharing Alliance
COTA, Inc. is now a proud member of the Clinical Research Data Sharing Alliance (CRDSA). This cross-industry alliance is dedicated to accelerating the discovery and delivery of life-saving therapies through the use of high-quality clinical trials and real-world data.
What Makes a Fit-for-Purpose Database for Clinical Oncology Research?
A fit-for-purpose database includes key variables, reliable and accurate data, and representative samples that can be used to draw meaningful conclusions. RWD can be highly valuable in supporting clinical oncology research, but choosing the right data is essential. The keys to finding the right fit-for-purpose database include relevance, reliability, integrity, and bias.
How Real-World Data Helps Explore Alternative Dosing for Colorectal, Pancreatic Cancer Therapy
Research from MedStar Georgetown Lombardi Comprehensive Cancer Center and COTA shows the potential of a more patient-friendly dosing regimen for Stage 4 CRC/PC or locally advanced PC.
This collaboration highlights how real-world data can contribute to clinical research and can help answer pressing questions about care already taking place in clinical practice.
Key Takeaways from ASH 2022: Real-World Data Gets Down to Business
The American Society of Hematology’s 2021 annual meeting showed that real-world data is no longer the new kid on the block – it’s an indispensable part of the toolkit for therapeutic development and clinical research. COTA is proud to be a part of the discussion, contributing research this year for chronic lymphocytic leukemia.
Are Pharma Companies Ready to Harness the Promises of Real-World Data?
Partnering with Impatient Health, we take a comprehensive look at the realities of real-world data and the challenges that pharma companies face in leveraging it to gain actionable insight, based on feedback from executives at well-known, major pharma companies.
This is a key part of our mission to provide the most comprehensive cancer care possible by leveraging the latest advances in data science and technology.
