FDA recognizes the investment made by sponsors over the past decade to develop the expertise and infrastructure to utilize Clinical Data Interchange Standards Consortium (CDISC)[1] standards for study data. T
FDA recognizes the investment made by sponsors over the past decade to develop the expertise and infrastructure to utilize Clinical Data Interchange Standards Consortium (CDISC)[1] standards for study data. The submission of standardized study data enhances a reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product.
The Prescription Drug User Fee Act (PDUFA V)[2] Performance Goals state that FDA will develop guidance for industry on the use of CDISC data standards for the electronic submission of study data in applications. In the near future, FDA will publish guidance that will require study data in conformance to CDISC standards.[3]
FDA envisions a semantically interoperable and sustainable submission environment that serves both regulated clinical research and health care. To this end, FDA will continue to research and evaluate, with its stakeholders, potential new approaches to current and emerging data standards. FDA does not foresee the replacement of CDISC standards for study data and will not implement new approaches without public input on the cost and utility of those approaches.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.