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Multiple Data Sources Show That Decentralized Clinical Trials Pay Off

ByAaron Csicseri

Traditional clinical trials are typically conducted at central locations or sites that patients must travel to in order to be evaluated and treated by trial investigators. These are referred to as centralized clinical trials. In contrast, a decentralized clinical trial (DCT) has no set location for patients to report to. Rather, clinical trial activities are…

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Regulatory Policy Watch: The FDA Is Taking Accelerated Approval Pathway Reforms Into Their Own Hands

ByAngela Corona

On September 30, 2022, President Biden signed into law the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), which will be in place for the next 5 years. Despite extensive bipartisan efforts to include reforms of the accelerated approval (AA) pathway as so-called “policy riders” in the bill, ultimately a “practically clean” version…