Drugs

Cardinal Health Contract on Real World Evidence

FDA has awarded Cardinal Health a $750,000 contract to implement an 18-month real world evidence (RWE) study to help the agency advance RWE in regulatory decision-making. The grant is intended to support FDA’s Assessment of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real-World Studies project, which 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,” Cardinal Health says.

In the research, Cardinal Health will work with FDA’s Oncology Center of Excellence. Despite increased focus at FDA with using RWD to support regulatory decision making, “the field currently lacks standardization in tumor response assessment that provide for reproducibility of results,” Cardinal Health says. “This research could provide important insights to inform RWD study designs or study methodology for such a purpose.”

Meanwhile, FDA’s drug user fee program that begins 10/1/2022 proposes to advance a new pilot program around real-world evidence to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications of approved medical products or to satisfy post-approval study requirements (see earlier story). And, earlier this year FDA announced it was funding a RWE demonstration project called Randomized Controlled Trials Duplicated using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology. The project will attempt to duplicate the results of recently completed randomized controlled clinical trials relevant to regulatory decision-making using RWE, based on health insurance claims data, FDA says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome