Tag: RWE

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Real-World Evidence (RWE) Studies in APAC: Regulatory Pathways, Site Qualification, and Key Considerations Before Protocol Finalization

Sponsors running real-world evidence studies in APAC face a different planning challenge from those running interventional trials. The study design is not the primary source of complexity. The data infrastructure is. So is each market’s regulatory acceptance posture and the site capability to manage observational methodology. Sponsors who treat the APAC region as a single […]

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Trial Designs Using Real-World Data (RWD)

Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions and now in clinical trial designs. The gold standard for demonstrating the efficacy of clinical trials since the 1960s has been randomized controlled trials (RCTs). We require at least two pivotal RCTs on the market for investigational medications. RCTs […]

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Real World Data & Real World Evidence In Clinical Trials

The clinical research landscape is shifting drastically due to an increase in the availability of electronic data allowing researchers to make assessments based on available real-world evidence (RWE) obtained from the analysis of real-world data (RWD). Global regulators are encouraging researchers/drug developers utilize the RWE for submissions. Many regulators are accepting the Real-world evidence (RWE) […]

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