Real World Evidence? I-MASK+ Protocol: Ivermectin Key for Prophylaxis and Early Treatment of COVID-19

Real World Evidence I-MASK+ Protocol Ivermectin Key for Prophylaxis and Early Treatment of COVID-19

Real world evidence (RWE) means medical evidence obtained from real world data (RWD), that is observational data, secured from outside the context of clinical trials and rather produced during routine clinical practice. The 21st Century Cures Act, enacted as law in 2016, heavily supported by the pharmaceutical industry, mandated the use of Real World Evidence (RWE). The intention of the Act largely was to expedite the approval process including easing the requirements placed on clinical trial sponsors seeking U.S. Food and Drug Administration (FDA) approval on new products or new indications on existing drugs. For example, the new ACT supported a company to provide “data summaries'' and “real world evidence”, such as observational studies, insurance claims data, patient input, rather full clinical trial results, at least in certain situations. With its passing, the FDA embraced RWE, noting that RWE and RWD are playing an increasing role in health care decisions. With the onset of the COVID-19 pandemic, a collaboration in Australia led by Monash University identified in a lab that an approved FDA drug, one with a well-established safety record, Ivermectin, is actually an inhibitor ...

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