In our April issue:
FEATURED
Optimizing RWE Generation
Rob Sambrook
Studies designed to incorporate real-world evidence are, in the scheme of clinical research, relatively straightforward to conduct. Yet, as explored here, it is important to involve epidemiologists in these studies from their inception to help minimize bias and ensure external validity.
FDA's 'Real-World' Framework
Beth Schurman
This report examines the scope of FDA's proposed Real-World Evidence Program—its draft framework for using RWE to support new drug approvals—and the potential implications for pharmaceutical manufacturers.
Research Data: The Quest to Standardize
Barbara Jauregui, Lynn D. Hudson, Lauren B. Becnel, Eileen Navarro Almario,
Ronald Fitzmartin, Frank Pétavy, Nathalie Seigneuret, James K. Malone, Fang
Liz Zhou, Jose Galvez, Tammy Jackson, Nicole Harmon, Rebecca D. Kush
Clinical research is only as effective as its ability to impact and benefit health and patients at large. Authors present the latest government, industry, and public health efforts to promote global common standards in the collection and sharing of clinical trial data.
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