Cardinal Health announced it has been awarded a $750,000 contract by the 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.
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