The Center for Drug Evaluation (CDE) has released two important documents: the “Guiding Principles of Real-World Drug Research Design and Program Framework (trial)” and the “Guiding Principles of Communication and Exchange of Real-World Evidence Supporting Drug Registration Applications (trial).” These guidelines are designed to enhance the quality and efficiency of drug research and development by providing comprehensive frameworks for real-world studies.
Guidelines for Real-World Study Design
The first set of guidelines focuses on the basic considerations of real-world study design and protocol formulation in drug research and development and evaluation. It provides comprehensive guidance on the overall design, research population, follow-up, data management, quality control, and other areas related to real-world drug research. This document aims to ensure that studies are conducted with the highest standards of scientific rigor and ethical considerations.
Guidelines for Communication and Evidence Exchange
The second set of guidelines addresses the core issues to be discussed in the communication and exchange of real-world evidence. It outlines the requirements for meeting materials when using real-world evidence as the key evidence for efficacy and/or safety evaluation to support drug registration applications. The guidelines also provide suggestions for sponsors to carry out communication and exchange at key time nodes, thereby improving the efficiency of drug clinical research and development. This document is crucial for ensuring that real-world evidence is used effectively and appropriately in the drug approval process.-Fineline Info & Tech
