Global Medical Sciences Group Looks At Benefits, Challenges And Risks Of Using RWD
The non-profit Council for International Organizations of Medical Sciences (CIOMS) has issued draft recommendations on using real-world evidence for the approval, use and reimbursement of medicinal products.
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The European Medicines Agency has responded to an analysis that argued that generating evidence for decision making in health care using observational real-world data, and thus potentially replacing randomized controlled trials, “is the wrong remedy for the challenges in drug development.”
The European Medicines Agency is preparing to roll out simplified transparency rules for its Clinical Trials Information System in mid-2024. This article looks at what will change and the impact on the thousands of trials that are already in the system.
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