Cardinal Health Awarded FDA Funding to Assess Real World Evidence Results Against Clinical Trials

Rhea-AI Summary

Cardinal Health (NYSE: CAH) has secured a $750,000 contract from the FDA for an 18-month study examining real-world evidence (RWE) in lymphoma treatment. The study, titled 'Assessment of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real-World Studies,' aims to compare real-world data (RWD) with central review standards in clinical trials. This initiative supports the FDA's increasing focus on RWE following the 21st Century Cures Act and seeks to improve patient outcomes through enhanced regulatory decision-making.

Positive

• Awarded a $750,000 contract by the FDA for a study on real-world evidence in lymphoma.
• Study aims to bridge clinical trial measures and real-world patient data to improve treatment responses.
• Aligns with FDA's focus on utilizing real-world data for regulatory decisions.

Negative

• None.

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

 

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SOURCE Cardinal Health

FAQ

What is the purpose of Cardinal Health's FDA-funded study?

The study aims to evaluate the accuracy of real-world data in assessing lymphoma tumor response compared to blinded independent central review.

How much funding did Cardinal Health receive from the FDA?

Cardinal Health received a $750,000 contract from the FDA for the study.

What implications does this study have for regulatory decision-making?

The study could inform real-world data designs and methodologies, enhancing the FDA's regulatory framework.

When was the contract awarded to Cardinal Health?

The contract was awarded on October 28, 2021.