News and Media

Latest News Release
01/31/2024

Transaction creates increased clinical and economic value for 11,500 specialty providers, including more than 7,000 physicians across 1,200 independent physician practices Transaction creates...

Top feature box IMAGE ONLY - COMPANY NEWS

Press Releases

Cardinal Health Awarded FDA Funding to Assess Real World Evidence Results Against Clinical Trials
10/28/2021
Cardinal Health will explore how to better standardize real world evidence for use in regulatory decisions

DUBLIN, Ohio, Oct. 28, 2021 /PRNewswire/ -- Cardinal Health (NYSE: CAH) announced today it has been awarded a $750,000 contract by the U.S. Food and Drug Administration (FDA) to implement an 18-month real world evidence (RWE) study as part of the agency's efforts to advance the applicability of RWE in regulatory decision-making.

The funding, which will support the project "Assessment of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real-World Studies," will evaluate the accuracy of real-world data (RWD) for lymphoma tumor response compared to blinded independent central review, the gold standard in randomized clinical trials. Within this research, Cardinal Health will work with the FDA Oncology Center of Excellence to assess tumor response in the clinical care setting.

"The utilization of real world evidence can ultimately lead to improving the patient experience by providing quicker access to safer therapies, but only if the potential is fully realized by bridging the measures used in clinical trials to those observed in real world patients," said Eli Phillips, Jr., PharmD, JD, vice president of Regulatory Sciences and Insights & Engagement, Cardinal Health. "I'm proud that Cardinal Health's commitment to advancing patient care through the use of real world evidence for regulatory objectives has been recognized by the FDA with this award to further our research."

Since Congress passed the 21st Century Cures Act in 2016, the FDA has placed increased focus on evaluating opportunities to use RWD to support regulatory decision making, including supporting the expansion of indications for currently approved drugs. However, despite potential utility of RWD usage, the field currently lacks standardization in tumor response assessment that provide for reproducibility of results. This research could provide important insights to inform RWD study designs or study methodology for such a purpose.

About Cardinal Health 
Cardinal Health (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

Media Contact: Andrew Stern, andrew.stern@cardinalhealth.com

 

 

SOURCE Cardinal Health

More Company News
09/10/2024

In observance of today's World Suicide Prevention Day, Children's Hospital Association (CHA), Cardinal Health (NYSE: CAH), and Zero Suicide Institute (ZSI) celebrate early success of the...

08/28/2024

'Warehouse of the Future' to expand nationwide distribution network in support of home healthcare growth DUBLIN, Ohio, Aug. 28, 2024 /PRNewswire/ -- Cardinal Health (NYSE: CAH) officially...

08/21/2024

New facility opening in Walton Hills demonstrates ongoing commitment to increase U.S. warehouse capacity and modernize operations DUBLIN, Ohio, Aug. 21, 2024 /PRNewswire/ -- Cardinal Health (NYSE:...

08/15/2024

Cardinal Health (NYSE: CAH) announced today that its Board of Directors approved a quarterly dividend of $0.5056 per share out of the Company's capital surplus. The dividend will be payable on...

View all company news »