Flatiron Health and FDA’s Oncology Center of Excellence renewed their collaboration to jointly develop and implement specific research projects to advance the use of real-world data and explore the potential strengths and limitations of using real-world evidence for regulatory purposes. The partnership will specifically evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer.
FDA has established the Oncology Quality, Characterization and Assessment of Real-World Data initiative.
Leal Health, formerly known as Trialjectory, presented data on the negative impact of Eastern Cooperative Oncology Group, or ECOG, performance status scores on cancer patients’ eligibility to enroll in clinical trials at the American Society of Clinical Oncology Genitourinary Cancers Symposium.
S2302 Pragmatica-Lung is a federally-funded, streamlined clinical trial examining a new combination of agents in patients with advanced non-small cell lung cancer (NSCLC). Like most studies, it is focused on improving outcomes for patients with cancer—but it is also poised to simplify and transform the entire clinical trials model as we know it.
The past six weeks have brought fundamental change in the way oncology drugs are being developed. At this unprecedented moment in oncopolitics, FDA, NCI, academic oncologists, advocates, and the industry are in agreement on how cancer therapies should be developed, tested and approved.
FDA has been mulling over reliance on real-world evidence for about a decade, keeping it on the edges of the existing approval system that runs on data from conventional clinical trials.
As real-world evidence becomes ever more essential, a cancer health technology company that played a key role in modernizing 21st-century health data is capitalizing on its accomplishments in the U.S.—and moving into international markets to meet the growing demand for actionable data.
Noel Alaka was named vice president of life sciences COTA Inc.
A retrospective, observational study sponsored by G1 Therapeutics described the burden of myelosuppression and its impact on healthcare resource utilization in 3,277 patients being treated with chemotherapy for extensive-stage small-cell lung cancer. The study also described patient outcomes from 21 patients receiving Cosela (trilaciclib) prior to chemotherapy.
Miruna Sasu was named president and CEO of COTA Inc. In her new role, she will lead efforts to drive broader adoption of real-world data by the life sciences industry to safely accelerate the speed of development and reduce the cost of cancer drugs.
