Real-World Evidence Study Registration May Help Drive FDA Acceptance
US FDA’s David Martin encourages sponsors to register observational studies on drug effectiveness to enhance transparency and agency confidence in the data.
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Real-World Evidence Registry Aims To Build Research Credibility Through Transparency
Pre-registration of study protocols will be voluntary and concerns with revealing proprietary information, among other issues, could be a deterrent to participation. But the developers of the registry hope that researchers will conclude the benefits of doing so outweigh the risks.
US FDA Is Hesitant About Using Observational Studies In Real-World Evidence Framework
Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.
Reality Check For Real World Data: FDA’s Sentinel Network Enters “Production” Stage
FDA’s Sentinel drug safety surveillance network has completed an important transition, moving from “experimental” to “production stage” as a tool to help inform post-market safety decisions. Now the question is whether real-world data can be used in making efficacy decisions.